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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03961815
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The purpose of this study is to permit participants who successfully completed or early terminated due to lack of efficacy from 3150-301-008, or successfully completed 3150-302-008, 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

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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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 28, 2024
Estimated Study Completion Date : April 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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 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
Lead-in study responders to treatment will receive subcutaneous Brazikumab every 4 weeks through Week 52 starting at Day 1




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 ]


Information from the National Library of Medicine

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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 3150-301-008, successful completion of 301-302-008, 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 3150-303-008.
  • Females who are pregnant, nursing, or planning a pregnancy during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961815


Locations
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United States, Florida
Gastro Florida
Tampa, Florida, United States, 33626
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Aparna Sahoo, DO Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03961815     History of Changes
Other Study ID Numbers: 3150-303-008
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases