Last updated on May 2020

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

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) | Crohn's Disease
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Participants who have entered and completed Study M16-006 or Study M15-991 or Study M15-989.
  • Participants have completed the study M16-006 or M15-991 and have achieved clinical response.

Exclusion Criteria:

  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .
  • Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), or had an adverse event (AE) during Studies M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the participant unsuitable for this study.
  • Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989.
  • Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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