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



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/24/2019
Start Date:April 9, 2018
End Date:May 31, 2026
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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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 subjects
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
subjects 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 subjects who completed Sub-study 1, Sub-study 2 or the Phase 2,
open-label extension study M15-989.


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.
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