NCT03105102.

Trial name or title	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
Methods	The study consists of 3 substudies, as follows: Substudy 1 (randomised, double‐blind, placebo‐controlled trial) 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; Substudy 2 (randomised, 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; Substudy 3 (open‐label, long‐term extension study) to evaluate long‐term safety of risankizumab in subjects who completed substudy 1 or 2.
Participants	Adults (16 ‐ 80 years) with Crohn's disease who have completed study M16‐006 or study M15‐991 and have achieved clinical response
Interventions	Experimental: Double‐blind risankizumab dose 1 (substudy 1) ‐ Participants randomised to receive double‐blind risankizumab dose 1 for 52 weeks Experimental: Double‐blind risankizumab dose 2 (substudy 1) ‐ Participants randomised to receive double‐blind risankizumab dose 2 for 52 weeks. Placebo Comparator: Double‐blind placebo for risankizumab (substudy 1) ‐ Participants randomised to receive double‐blind placebo for risankizumab for 52 weeks Experimental: Maintenance risankizumab dose 1 (substudy 2) ‐ Participants randomised to receive 1 dose of double‐blind risankizumab dose 1 followed by open‐label risankizumab for 52 weeks Experimental: Maintenance risankizumab dose 2 (substudy 2) ‐ Participants randomised to receive 1 dose of double‐blind risankizumab dose 2 followed by open‐label risankizumab for 52 weeks Experimental: Open‐label risankizumab (substudy 3) ‐ Participants who completed substudy 1 or substudy 2 will receive open‐label risankizumab beginning at Week 56
Outcomes	Primary outcomes: Clinical remission (average daily SF and average daily AP at week 52) Endoscopic response (SES‐CD at week 52) Secondary outcomes: Clinical remission (CDAI at week 52) Discontinued corticosteroid use and achieved clinical remission (average daily SF and average daily AP score at Week 52) Discontinued corticosteroid use (at week 52) Sustained clinical remission (average daily SF and average daily AP score at both week 0 and week 52) Enhanced clinical response (decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score at week 52) Clinical remission (average daily stool frequency and average daily abdominal pain score) and endoscopic response (SES‐CD at week 52) Endoscopic healing (SES‐CD at week 52) Severity of Crohn's disease symptoms (Crohn's Symptom Severity at week 52) Resolution of extra‐intestinal manifestation (at week 52) Deep remission, both clinical remission (per average daily SF and average daily AP score) and endoscopic healing (SES‐CD at week 52) Hospitalisation (through to week 52) Draining fistula (at week 52) Fatigue (FACIT‐F at week 52) Overall health status (SF‐36 at week 12) Crohn's disease‐related surgeries (through to week 12)
Starting date	September 2017
Contact information	AbbVie Call Center Telephone: 8472838955 Email: abbvieclinicaltrials@abbvie.com
Notes	Estimated completion date: September 2022 Estimated enrollment: 912 participants