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52-Week Crohn's Disease Study

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ClinicalTrials.gov Identifier: NCT03759288
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Crohn's Disease IBD Drug: Brazikumab low dose Drug: Brazikumab high dose Drug: Humira® Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : December 4, 2022
Estimated Study Completion Date : December 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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
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

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
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

Active Comparator: (Stage 1) Humira®
Subcutaneous Humira® on Day 1, Day 15, Day 29 and every 2 weeks through Week 50
Drug: Humira®
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.

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
Drug: Placebo
Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 2 weeks through Week 50

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
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

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
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

Active Comparator: (Stage 2) Humira®
Subcutaneous Humira® on Day 1, Day 15, Day 29 and every 2 weeks through Week 50
Drug: Humira®
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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




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 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.

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): NCT03759288


Contacts
Contact: Clinical Trial Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
United States, Arkansas
Applied Research Center of Arkansas Recruiting
Little Rock, Arkansas, United States, 72212
United States, California
Clinical Trials Research Recruiting
Lincoln, California, United States, 95648
United States, Florida
Top Medical Research Recruiting
Cutler Bay, Florida, United States, 33189
Sanchez Clinical Research, Inc Recruiting
Miami, Florida, United States, 33157
Medical Professional Clinical Research Center, INC. Recruiting
Miami, Florida, United States, 33165
Gastro Florida Recruiting
Tampa, Florida, United States, 33762
Contact: Study Coordinator    727-347-0536      
United States, Illinois
Illinois Gastroenterology Group, LLC Recruiting
Gurnee, Illinois, United States, 60031
United States, Indiana
Investigators Research Group, LLC Recruiting
Brownsburg, Indiana, United States, 46112
United States, Kansas
Kansas Medical Clinic Recruiting
Topeka, Kansas, United States, 66606
United States, New York
Trialspark, Inc. Recruiting
New York, New York, United States, 10012
United States, North Carolina
Lucas Research Recruiting
Morehead City, North Carolina, United States, 28557
United States, Texas
Centex Studies, Inc. - Houston Recruiting
Houston, Texas, United States, 77058
Sponsors and Collaborators
Allergan
Investigators
Study Director: Aparna Sahoo, DO Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03759288     History of Changes
Other Study ID Numbers: 3150-301-008
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents