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

  • Interventional
  • Recruiting
  • NCT03105102
Eligibility Details Visit Clinicaltrials.gov

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension 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

The study consists of 3 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991 - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.

Gender
All

Age Group
18 Years to 80 Years

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03105102

IRB#IRB18-0739

Lead SponsorAbbVie

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
18 Years to 80 Years
Recruiting