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出境医 / 临床实验 / Open-label Extension Study of Brazikumab in Crohn's Disease (Intrepid)

Open-label Extension Study of Brazikumab in Crohn's Disease (Intrepid)

Study Description
Brief Summary:
The purpose of this study is to permit participants who successfully completed or early terminated due to lack of efficacy from D5271C00001 (Legacy # 3150-301-008) or discontinued from therapy due to termination of study 5170C00002 to receive open-label Brazikumab for an additional 52 weeks.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Brazikumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : April 14, 2025
Estimated Study Completion Date : April 14, 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: Brazikumab Induction Dose
Intravenous Brazikumab on Days 1, 29, and 57 followed by subcutaneous Brazikumab every 4 weeks through Week 52
 Drug: Brazikumab
Non-responders (or partial responders) to treatment from the lead-in studies D5271C00001 (Legacy #3150-301-008) and D5170C00002 may receive an induction dose regimen of intravenous Brazikumab on Days 1, 29, and 57 followed by subcutaneous Brazikumab every 4 weeks through Week 52
Experimental: Brazikumab Maintenance Dose
Subcutaneous Brazikumab every 4 weeks through Week 52 starting at Day 1
 Drug: Brazikumab
D5271C00001 (Legacy #3150-301-008) and D5170C00002 lead-in study responders to treatment will receive subcutaneous Brazikumab every 4 weeks through Week 52 starting at Day 1
Outcome Measures
Primary Outcome Measures :
  1. To assess the safety of long-term treatment with Brazikumab in patients with Crohn's disease (CD) based on the number of patients who experience one or more Treatment Emergent Adverse Events (TEAE) [ Time Frame: Across the 52-week treatment period ]
  2. Percentage of participants with potentially clinically significant vital sign measurements [ Time Frame: Across the 52-week treatment period ]
  3. Percentage of participants with potentially clinically significant laboratory values [ Time Frame: Across the 52-week treatment period ]
  4. Percentage of participants with potentially clinically significant electrocardiograms [ Time Frame: Across the 52-week treatment period ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successful completion or early termination due to insufficient therapeutic response from D5271C00001 (Legacy #3150-301-008), or discontinued from treatment in D5170C00002 due to study termination
  • No prior history of active TB and meets all TB-related criteria
  • Consent to ileocolonoscopy at required time points.
  • Agree to comply with contraception requirements for the study.

Exclusion Criteria:

  • Any participant with an unresolved AE from a lead-in study, that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study.
  • Current diagnosis of ischemic colitis, colonic mucosal dysplasia, primary sclerosingcholangitis, or any demyelinating condition.
  • Any other condition or finding that, in the investigator's opinion, would either confound proper interpretation of the study or expose a participant to unacceptable risk.
  • Participant meets criteria for discontinuation of study intervention during prior lead-in study.
  • Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication), biological treatment or prohibited treatment.
  • Participant does not agree to refrain from receiving live vaccinations during the course of the study.
  • Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study D5271C00002 (Legacy #3150-303-008).
  • Females who are pregnant, nursing, or planning a pregnancy during the study.
Contacts and Locations

Locations
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United States, California
Research Site
Lincoln, California, United States, 95648
United States, Florida
Research Site
Clearwater, Florida, United States, 33756
Research Site
Kissimmee, Florida, United States, 34741
Research Site
Lakeland, Florida, United States, 33813
Research Site
Miami Lakes, Florida, United States, 33016
Research Site
Miami, Florida, United States, 33157
Research Site
Miami, Florida, United States, 33165
Research Site
Tampa, Florida, United States, 33626
United States, Indiana
Research Site
Brownsburg, Indiana, United States, 46112
United States, Michigan
Research Site
Farmington Hills, Michigan, United States, 48334
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87108
United States, Ohio
Research Site
Beachwood, Ohio, United States, 44122
United States, Texas
Research Site
Houston, Texas, United States, 77058
Austria
Research Site
Innsbruck, Austria, 6020
Research Site
Steyr, Austria, 4400
Research Site
Wels, Austria, 4600
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Kathy Bohannon AstraZeneca
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE May 20, 2019
Estimated Primary Completion Date April 14, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • To assess the safety of long-term treatment with Brazikumab in patients with Crohn's disease (CD) based on the number of patients who experience one or more Treatment Emergent Adverse Events (TEAE) [ Time Frame: Across the 52-week treatment period ]
  • Percentage of participants with potentially clinically significant vital sign measurements [ Time Frame: Across the 52-week treatment period ]
  • Percentage of participants with potentially clinically significant laboratory values [ Time Frame: Across the 52-week treatment period ]
  • Percentage of participants with potentially clinically significant electrocardiograms [ Time Frame: Across the 52-week treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Extension Study of Brazikumab in Crohn's Disease
Official Title  ICMJE An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Brief Summary The purpose of this study is to permit participants who successfully completed or early terminated due to lack of efficacy from D5271C00001 (Legacy # 3150-301-008) or discontinued from therapy due to termination of study 5170C00002 to receive open-label Brazikumab for an additional 52 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Brazikumab
    Non-responders (or partial responders) to treatment from the lead-in studies D5271C00001 (Legacy #3150-301-008) and D5170C00002 may receive an induction dose regimen of intravenous Brazikumab on Days 1, 29, and 57 followed by subcutaneous Brazikumab every 4 weeks through Week 52
  • Drug: Brazikumab
    D5271C00001 (Legacy #3150-301-008) and D5170C00002 lead-in study responders to treatment will receive subcutaneous Brazikumab every 4 weeks through Week 52 starting at Day 1
Study Arms  ICMJE
  • Experimental: Brazikumab Induction Dose
    Intravenous Brazikumab on Days 1, 29, and 57 followed by subcutaneous Brazikumab every 4 weeks through Week 52
    Intervention: Drug: Brazikumab
  • Experimental: Brazikumab Maintenance Dose
    Subcutaneous Brazikumab every 4 weeks through Week 52 starting at Day 1
    Intervention: Drug: Brazikumab
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
 (submitted: May 21, 2019) 		1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 14, 2025
Estimated Primary Completion Date April 14, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Successful completion or early termination due to insufficient therapeutic response from D5271C00001 (Legacy #3150-301-008), or discontinued from treatment in D5170C00002 due to study termination
  • No prior history of active TB and meets all TB-related criteria
  • Consent to ileocolonoscopy at required time points.
  • Agree to comply with contraception requirements for the study.

Exclusion Criteria:

  • Any participant with an unresolved AE from a lead-in study, that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study.
  • Current diagnosis of ischemic colitis, colonic mucosal dysplasia, primary sclerosingcholangitis, or any demyelinating condition.
  • Any other condition or finding that, in the investigator's opinion, would either confound proper interpretation of the study or expose a participant to unacceptable risk.
  • Participant meets criteria for discontinuation of study intervention during prior lead-in study.
  • Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication), biological treatment or prohibited treatment.
  • Participant does not agree to refrain from receiving live vaccinations during the course of the study.
  • Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study D5271C00002 (Legacy #3150-303-008).
  • Females who are pregnant, nursing, or planning a pregnancy during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, 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 Austria,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961815
Other Study ID Numbers  ICMJE D5271C00002
2019-001866-14 ( EudraCT Number )
Has Data Monitoring Committee No
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: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kathy Bohannon AstraZeneca
PRS Account AstraZeneca
Verification Date May 2021

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

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