Last updated on July 2019

A Study of the Efficacy and Safety of Risankizumab in Subjects 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: Crohn's Disease
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

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

Exclusion Criteria:

  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .
  • Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Studies M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the subject unsuitable for this study.
  • Subject 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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