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出境医 / 临床实验 / A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

Study Description
Brief Summary:

The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.

The secondary objectives of the study are:

  • To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
  • To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
  • To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Pain Drug: REGN5069 Drug: Matching Placebo Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Actual Study Start Date : May 21, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : October 29, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: REGN5069 Low Dose
Randomized in a 1:1:1 ratio
Drug: REGN5069
Intravenous (IV) Dose every 4 weeks (Q4W)

Experimental: REGN5069 High Dose
Randomized in a 1:1:1 ratio
Drug: REGN5069
Intravenous (IV) Dose every 4 weeks (Q4W)

Experimental: Matching Placebo
Randomized in a 1:1:1 ratio
Drug: Matching Placebo
Intravenous (IV) Dose every 4 weeks (QW4)

Outcome Measures
Primary Outcome Measures :
  1. Change from baseline to week 12 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)


Secondary Outcome Measures :
  1. Change from baseline to week 12 in the WOMAC total score (based on the full survey) in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)

  2. Change from baseline to week 12 in the WOMAC physical function subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)

  3. Change from baseline to week 12 in the Patient Global Assessment score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The Patient Global Assessment of OA is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor)

  4. Change from baseline to week 12 in WOMAC stiffness subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)

  5. Percentage of patients treated with REGN5069, compared to that of patients treated with placebo, who had a response at week 12, with response defined as an improvement by ≥30% in the WOMAC pain subscale scores [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)

  6. Incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (52 weeks) ]
  7. Incidence of imaging abnormalities consistent with accelerated arthropathies as assessed by X-ray and MRI in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (52 weeks) ]
  8. Presence of anti-REGN5069 antibody development in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (52 weeks) ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Generally in good health at the screening visit
  • Body mass index (BMI) ≤39 kg/m2 at the screening visit
  • Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit
  • Moderate-to-severe pain in the index joint
  • A history of inadequate pain relief from or intolerance to analgesics used for OA

Key Exclusion Criteria:

  • Diagnosis of systemic diseases that may affect joints
  • History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or MRI as assessed by the central imaging reader.
  • Is scheduled for a joint replacement surgery to be performed during the study period
  • Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
  • Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit (topical, intranasal, or inhaled corticosteroids are permitted).
  • History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
  • Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study
  • History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit

Note: Other protocol defined inclusion/exclusion criteria apply.

Contacts and Locations

Locations
Layout table for location information
United States, Florida
Regeneron Study Site
DeLand, Florida, United States, 32720
Regeneron Study Site
Jupiter, Florida, United States, 33458
Regeneron Study Site
Miami, Florida, United States, 33143
United States, South Carolina
Regeneron Study Site
Charleston, South Carolina, United States, 29406
Georgia
Regeneron Study Site
Tbilisi, Georgia, 112
Moldova, Republic of
Regeneron Study Site
Chisinau, Moldova, Republic of, MD2025
Poland
Regeneron Study Site
Zgierz, Lodzkie, Poland, 95-100
Regeneron Study Site
Lublin, Lubelskie, Poland, 20-412
Regeneron Study Site
Zamosc, Lubelskie, Poland, 22-400
Regeneron Study Site
Warsaw, Mazowieckie, Poland, 02 - 777
Regeneron Study Site
Bialystok, Podlaskie, Poland, 15-879
Ukraine
Regeneron Study Site
Kyiv, Ukraine, 1135
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE May 21, 2019
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
Change from baseline to week 12 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to Week 12 ]
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • Change from baseline to week 12 in the WOMAC total score (based on the full survey) in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
  • Change from baseline to week 12 in the WOMAC physical function subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
  • Change from baseline to week 12 in the Patient Global Assessment score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The Patient Global Assessment of OA is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor)
  • Change from baseline to week 12 in WOMAC stiffness subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
  • Percentage of patients treated with REGN5069, compared to that of patients treated with placebo, who had a response at week 12, with response defined as an improvement by ≥30% in the WOMAC pain subscale scores [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
  • Incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (52 weeks) ]
  • Incidence of imaging abnormalities consistent with accelerated arthropathies as assessed by X-ray and MRI in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (52 weeks) ]
  • Presence of anti-REGN5069 antibody development in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (52 weeks) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Change from baseline to week 12 in the WOMAC total score (based on the full survey) in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
  • Change from baseline to week 12 in the WOMAC physical function subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
  • Change from baseline to week 12 in the Patient Global Assessment score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The Patient Global Assessment of OA is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor)
  • Change from baseline to week 12 in WOMAC stiffness subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
  • Percentage of patients treated with REGN5069, compared to that of patients treated with placebo, who had a response at week 12, with response defined as an improvement by ≥30% in the WOMAC pain subscale scores [ Time Frame: Baseline to week 12 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
  • Incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (36 weeks) ]
  • Incidence of imaging abnormalities consistent with accelerated arthropathies as assessed by X-ray and MRI in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (36 weeks) ]
  • Presence of anti-REGN5069 antibody development in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Through the study duration (36 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Official Title  ICMJE A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Brief Summary

The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.

The secondary objectives of the study are:

  • To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
  • To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
  • To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis of the Knee
  • Pain
Intervention  ICMJE
  • Drug: REGN5069
    Intravenous (IV) Dose every 4 weeks (Q4W)
  • Drug: Matching Placebo
    Intravenous (IV) Dose every 4 weeks (QW4)
Study Arms  ICMJE
  • Experimental: REGN5069 Low Dose
    Randomized in a 1:1:1 ratio
    Intervention: Drug: REGN5069
  • Experimental: REGN5069 High Dose
    Randomized in a 1:1:1 ratio
    Intervention: Drug: REGN5069
  • Experimental: Matching Placebo
    Randomized in a 1:1:1 ratio
    Intervention: Drug: Matching Placebo
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2020)
259
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2019)
240
Actual Study Completion Date  ICMJE October 29, 2020
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Generally in good health at the screening visit
  • Body mass index (BMI) ≤39 kg/m2 at the screening visit
  • Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit
  • Moderate-to-severe pain in the index joint
  • A history of inadequate pain relief from or intolerance to analgesics used for OA

Key Exclusion Criteria:

  • Diagnosis of systemic diseases that may affect joints
  • History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or MRI as assessed by the central imaging reader.
  • Is scheduled for a joint replacement surgery to be performed during the study period
  • Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
  • Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit (topical, intranasal, or inhaled corticosteroids are permitted).
  • History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
  • Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study
  • History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit

Note: Other protocol defined inclusion/exclusion criteria apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Georgia,   Moldova, Republic of,   Poland,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956550
Other Study ID Numbers  ICMJE R5069-OA-1849
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All IPD that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP