Last updated on June 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Inflammatory bowel disease | Crohn's Disease (Pediatric) | Irritable Bowel Syndrome (IBS- Pediatric) | Crohn's Disease | Irritable Bowel Syndrome | Irritable Bowel Syndrome (IBS)
  • Age: Between 16 - 80 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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