An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03759288
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Allergan
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Aparna Sahoo, DO
Principal Investigator Affiliation	Allergan
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Puerto Rico, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn's Disease, IBD

Arms & Interventions

Arms

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

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

Active Comparator: (Stage 1) Humira®

Subcutaneous Humira® on Day 1, Day 15, 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

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

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

Active Comparator: (Stage 2) Humira®

Subcutaneous Humira® on Day 1, Day 15, Day 29 and every 2 weeks through Week 50

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Shapiro Michael S MD, Scottsdale, Arizona

Status

Recruiting

Address

Shapiro Michael S MD

Scottsdale, Arizona, 85258

Site Contact

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