美国临床试验招募 A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE VITAL)-出境医

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出境医 / 临床实验 / A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE VITAL)

A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE VITAL)

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Study Description

Brief Summary:

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

Condition or disease	Intervention/treatment	Phase
Psoriatic Arthritis	Drug: Bimekizumab	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1045 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Actual Study Start Date :	August 13, 2019
Estimated Primary Completion Date :	May 2025
Estimated Study Completion Date :	May 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bimekzumab dosage regimen Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.	Drug: Bimekizumab Subjects will receive bimekizumab at pre-specified time-points. Other Names: BKZ UCB4940

Outcome Measures

Primary Outcome Measures :

Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Incidence of treatment-emergent serious adverse events (SAEs) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is an infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

Secondary Outcome Measures :

TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]

The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]

The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]

The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]

The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]

The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]

The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011.

The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.

The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]

A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011.

An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]

A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011.

An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]

A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011.

An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Exclusion Criteria:

Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated

Contacts and Locations

Locations

Show 115 study locations

Layout table for location information

United States, California

Pa0012 50035

San Diego, California, United States, 92128

United States, Florida

Pa0012 50033

Palm Harbor, Florida, United States, 34684

United States, Georgia

Pa0012 50039

Atlanta, Georgia, United States, 30342

United States, Idaho

Pa0012 50024

Boise, Idaho, United States, 83702

United States, Kentucky

Pa0012 50028

Lexington, Kentucky, United States, 40504

United States, Louisiana

Pa0012 50023

Baton Rouge, Louisiana, United States, 70836

United States, Maryland

Pa0012 50015

Hagerstown, Maryland, United States, 21742

Pa0012 50026

Wheaton, Maryland, United States, 20902

United States, Massachusetts

Pa0012 50047

Boston, Massachusetts, United States, 02115

United States, Michigan

Pa0012 50019

Lansing, Michigan, United States, 48910

United States, Missouri

Pa0012 50016

Saint Louis, Missouri, United States, 63141

United States, New Jersey

Pa0012 50005

Freehold, New Jersey, United States, 07728

United States, New Mexico

Pa0012 50029

Albuquerque, New Mexico, United States, 87102

United States, New York

Pa0012 50010

Brooklyn, New York, United States, 11201

Pa0012 50011

New York, New York, United States, 10003

Pa0012 50034

Rochester, New York, United States, 14642

United States, North Carolina

Pa0012 50125

Charlotte, North Carolina, United States, 28210

Pa0012 50031

Salisbury, North Carolina, United States, 28144

United States, Ohio

Pa0012 50040

Vandalia, Ohio, United States, 45377

United States, Pennsylvania

Pa0012 50020

Duncansville, Pennsylvania, United States, 16635

Pa0012 50006

Wyomissing, Pennsylvania, United States, 19610

United States, Rhode Island

Pa0012 50008

Johnston, Rhode Island, United States, 02919

United States, South Carolina

Pa0012 50007

Orangeburg, South Carolina, United States, 29118

United States, Tennessee

Pa0012 50001

Jackson, Tennessee, United States, 38305

Pa0012 50012

Memphis, Tennessee, United States, 38119

United States, Texas

Pa0012 50002

Austin, Texas, United States, 78731

Pa0012 50049

Corpus Christi, Texas, United States, 78404

Pa0012 50036

Mesquite, Texas, United States, 75150

Pa0012 50009

Waco, Texas, United States, 76710

United States, West Virginia

Pa0012 50050

Beckley, West Virginia, United States, 25801

Australia

Pa0012 30005

Camberwell, Australia

Pa0012 30008

Hobart, Australia

Pa0012 30006

Maroochydore, Australia

Pa0012 30007

Victoria Park, Australia

Pa0012 30006

Woodville South, Australia

Canada

Pa0012 50042

Rimouski, Canada

Pa0012 50043

Sydney, Canada

Pa0012 50044

Trois-Rivières, Canada

Czechia

Pa0012 40061

Brno, Czechia

Pa0012 40065

Brno, Czechia

Pa0012 40062

Ostrava, Czechia

Pa0012 40009

Pardubice, Czechia

Pa0012 40066

Praha 2, Czechia

Pa0012 40015

Praha 3, Czechia

Pa0012 40014

Praha 4, Czechia

Pa0012 40063

Praha 5, Czechia

Pa0012 40013

Praha, Czechia

Pa0012 40010

Uherské Hradiště, Czechia

Pa0012 40012

Zlín, Czechia

France

Pa0012 40068

Chambray-lès-Tours, France

Germany

Pa0012 40076

Cottbus, Germany

Pa0012 40117

Frankfurt, Germany

Pa0012 40029

Hamburg, Germany

Pa0012 40071

Hamburg, Germany

Pa0012 40078

Leipzig, Germany

Pa0012 40026

Ratingen, Germany

Hungary

Pa0012 40081

Budapest, Hungary

Pa0012 40083

Budapest, Hungary

Pa0012 40032

Debrecen, Hungary

Pa0012 40030

Eger, Hungary

Pa0012 40082

Kistarcsa, Hungary

Pa0012 40079

Szentes, Hungary

Pa0012 40033

Székesfehérvár, Hungary

Italy

Pa0012 40084

Catania, Italy

Japan

Pa0012 20030

Chuo Ku, Japan

Pa0012 20043

Itabashi-Ku, Japan

Pa0012 20036

Kawachi-Nagano-Shi, Japan

Pa0012 20045

Kita-Gun, Japan

Pa0012 20049

Kitakyushu, Japan

Pa0012 20044

Minato-Ku, Japan

Pa0012 20041

Osaka, Japan

Pa0012 20046

Osaka, Japan

Pa0012 20031

Sapporo, Japan

Pa0012 20042

Sasebo, Japan

Pa0012 20032

Suita, Japan

Poland

Pa0012 40093

Białystok, Poland

Pa0012 40119

Bydgoszcz, Poland

Pa0012 40038

Elbląg, Poland

Pa0012 40088

Elbląg, Poland

Pa0012 40096

Gdynia, Poland

Pa0012 40042

Kraków, Poland

Pa0012 40092

Kraków, Poland

Pa0012 40037

Lublin, Poland

Pa0012 40091

Nowa Sól, Poland

Pa0012 40044

Poznań, Poland

Pa0012 40090

Poznań, Poland

Pa0012 40118

Toruń, Poland

Pa0012 40041

Warsaw, Poland

Pa0012 40094

Warsaw, Poland

Pa0012 40097

Warsaw, Poland

Pa0012 40041

Warszawa, Poland

Pa0012 40098

Warszawa, Poland

Pa0012 40039

Wrocław, Poland

Pa0012 40043

Wrocław, Poland

Pa0012 40095

Wrocław, Poland

Russian Federation

Pa0012 20002

Moscow, Russian Federation

Pa0012 20005

Moscow, Russian Federation

Pa0012 20010

Moscow, Russian Federation

Pa0012 20017

Moscow, Russian Federation

Pa0012 20013

Petrozavodsk, Russian Federation

Pa0012 20012

Ryazan', Russian Federation

Pa0012 20016

Ryazan', Russian Federation

Pa0012 20001

Saint Petersburg, Russian Federation

Pa0012 20004

Saint Petersburg, Russian Federation

Pa0012 20009

Saint Petersburg, Russian Federation

Pa0012 20083

Saint Petersburg, Russian Federation

Tracking Information

First Submitted Date ^ICMJE

July 2, 2019

First Posted Date ^ICMJE

July 5, 2019

Last Update Posted Date

June 4, 2021

Actual Study Start Date ^ICMJE

August 13, 2019

Estimated Primary Completion Date

May 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Incidence of treatment-emergent serious adverse events (SAEs) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is an infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

Original Primary Outcome Measures ^ICMJE

Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Incidence of serious adverse events (SAEs) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is an infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

Change History

Current Secondary Outcome Measures ^ICMJE

TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011. An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011. An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011. An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.

Original Secondary Outcome Measures ^ICMJE

Adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 160) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at ≥3% of body surface area (BSA) at Baseline of PA0010 or PA0011. The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011. An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011. An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA ≥2 at the Baseline of PA0010 or PA0011. An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Official Title ^ICMJE

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Brief Summary

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Psoriatic Arthritis

Intervention ^ICMJE

Drug: Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

Other Names:

BKZ
UCB4940

Study Arms ^ICMJE

Experimental: Bimekzumab dosage regimen

Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.

Intervention: Drug: Bimekizumab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

1045

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

May 2025

Estimated Primary Completion Date

May 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Exclusion Criteria:

Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Russian Federation, Spain, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04009499

Other Study ID Numbers ^ICMJE

PA0012
2018-004725-86 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Clinical Study Report (CSR)
Time Frame:	Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria:	Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
URL:	http://www.Vivli.org