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An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759288
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 29, 2018
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE December 7, 2018
Estimated Primary Completion Date December 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
  • Stage 1. Percentage of participants with endoscopic response and clinical remission at Week 12 [ Time Frame: 12 Weeks ]
    Endoscopic response based on decrease from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Clinical remission based on average daily LSF (Loose Stool Frequency) and average daily AP (abdominal pain) score.
  • Stage 2. Percentage of participants with endoscopic response and clinical remission at Week 52 [ Time Frame: 52 Weeks ]
    Endoscopic response based on decrease from baseline in Simple Endoscopic Score for Crohn's Disease(SES-CD). Clinical remission based on average daily LSF (Loose Stool Frequency) and average daily AP (abdominal pain) score.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
  • Stage 1. Percentage of participants with endoscopic response and clinical remission at both Weeks 12 and 52 [ Time Frame: Up to 52 Weeks ]
    Endoscopic response based on decrease from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD). Clinical remission based on average daily LSF (Loose Stool Frequency) and average daily AP (abdominal pain) score.
  • Stage 1. Percentage of participants with endoscopic remission and clinical remission at Week 52 [ Time Frame: 52 Weeks ]
    Endoscopic remission based on decrease from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD). Clinical remission based on average daily LSF (Loose Stool Frequency) and average daily AP (abdominal pain) score.
  • Stage 1. Percentage of participants with endoscopic response at Week 12 and endoscopic remission at Week 52 and clinical remission at both Weeks 12 and 52 [ Time Frame: Up to 52 Weeks ]
    Endoscopic response and remission based on decrease from baseline in Simple Endoscopic Score for Crohn's Disease (SESCD). Clinical remission based on average daily LSF (Loose Stool Frequency) and average daily AP (abdominal pain) score.
  • Stage 2. Percentage of participants with endoscopic response and clinical remission at both Weeks 12 and 52 [ Time Frame: Up to 52 Weeks ]
    Endoscopic response based on decrease from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD). Clinical remission based on average daily LSF (Loose Stool Frequency) and average daily AP (abdominal pain) score.
  • Stage 2. Percentage of participants with endoscopic remission and clinical remission at Week 52 [ Time Frame: 52 Weeks ]
    Endoscopic remission based on decrease from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD). Clinical remission based on average daily LSF (Loose Stool Frequency) and average daily AP (abdominal pain) score.
  • Stage 2. Percentage of participants with corticosteriod-free endoscopic remission and clinical remission at Week 52 [ Time Frame: 52 Weeks ]
    Endoscopic remission based on decrease from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD). Clinical remission based on average daily LSF (Loose Stool Frequency) and average daily AP (abdominal pain) score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Official Title  ICMJE A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Brief Summary This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Crohn's Disease
  • IBD
Intervention  ICMJE
  • Drug: Brazikumab low dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous brazikumab on Day 85 and every 4 weeks through Week 48
  • Drug: Brazikumab high dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous brazikumab on Day 85 and every 4 weeks through Week 48
  • Drug: Humira®
    Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.
  • Drug: Placebo
    Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 2 weeks through Week 50
Study Arms  ICMJE
  • Experimental: (Stage 1) Brazikumab high dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
    Intervention: Drug: Brazikumab high dose
  • Experimental: (Stage 1) Brazikumab low dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous brazikumab on Day 85 and every 4 weeks through Week 48
    Intervention: Drug: Brazikumab low dose
  • Active Comparator: (Stage 1) Humira®
    Subcutaneous Humira® on Day 1, Day 15, Day 29 and every 2 weeks through Week 50
    Intervention: Drug: Humira®
  • Placebo Comparator: (Stage 1) Placebo
    Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 2 weeks through Week 50
    Intervention: Drug: Placebo
  • Experimental: (Stage 2) Brazikumab high dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
    Intervention: Drug: Brazikumab high dose
  • Experimental: (Stage 2) Brazikumab low dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab 240 on Day 85 and every 4 weeks through Week 48
    Intervention: Drug: Brazikumab low dose
  • Active Comparator: (Stage 2) Humira®
    Subcutaneous Humira® on Day 1, Day 15, Day 29 and every 2 weeks through Week 50
    Intervention: Drug: Humira®
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2018)
1140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 4, 2022
Estimated Primary Completion Date December 4, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion and Exclusion Criteria are the same for both Stage 1 and Stage 2; however, participants enrolled in Stage 1 will not be permitted to enroll in Stage 2.

Inclusion Criteria:

  • Aged 16 to 80 years, inclusive, at Screening. For participants less than 18 years of age, the participant must weigh at least 40 kg
  • Diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to screening
  • Moderately to severely active Crohn's Disease

Exclusion Criteria:

  • Participant is unable or unwilling to have endoscopic procedures performed during the study.
  • History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
  • Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to screening.
  • Participant has known history of drug (including opiates) or alcohol abuse.
  • Currently enrolled in another investigational device or drug study.
  • Participant is pregnant, breastfeeding, or plans to become pregnant 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: Clinical Trial Registry Team 877-277-8566 IR-CTRegistration@Allergan.com
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03759288
Other Study ID Numbers  ICMJE 3150-301-008
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: No
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aparna Sahoo, DO Allergan
PRS Account Allergan
Verification Date October 2020

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