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The Efficacy and Safety of Risankizumab in Participants With Moderate to Severe Crohn's Disease

UCI Specialty Area: Gastroenterology
Principal Investigator: Robert Fearn
Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn's Disease (M23-784)
A Study On:
Crohns Disease

Study Description

Eligibility

Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.

Participant meets the following disease activity criteria:

Moderate to severe CD as assessed by CDAI

Endoscopic evidence of mucosal inflammation as documented by a SES-CD

Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.

Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.

Participants with unstable doses of concomitant Crohn's disease therapy.

Participants with prior exposure to p19 inhibitors.

Participants with complications of Crohn's disease.

Participants having an ostomy or ileoanal pouch.

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
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