NCT03104413.

Trial name or title	A multicenter, randomized, double‐blind, placebo‐controlled induction study to assess the efficacy and safety of risankizumab in subjects with moderately to severely active Crohn's disease who failed prior biologic treatment
Methods	A multicentre, randomised, placebo‐controlled, double‐blinded trial
Participants	Patients (aged 16 ‐ 80 years ‐ Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the baseline visit) with a diagnosis of Crohn's disease for at least 3 months prior to baseline. A confirmed diagnosis of moderate‐to‐severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES‐CD). Demonstrated intolerance or inadequate response to biologic therapy for CD. If female, subject must meet the contraception recommendations.
Interventions	Placebo Comparator: Placebo (induction period 1) ‐ Subjects randomised to receive placebo for risankizumab in induction period 1. Experimental: Risankizumab dose 1 and dose 2 in induction period 1 Experimental: Risankizumab dose 1 (induction period 2): Participants who received placebo in period 1 and participants with inadequate response at week 12 in period 1 randomised to receive risankizumab dose 1 administered by intravenous (IV) infusion in period 2. Experimental: Risankizumab dose 2 (induction period 2) Participants with inadequate response at week 12 in period 1 randomised to receive risankizumab dose 2 administered by subcutaneous (SC) injection in period 2. Experimental: Risankizumab dose 3 (induction period 2) Participants with inadequate response at week 12 in period 1 randomised to receive risankizumab dose 3 administered by subcutaneous (SC) injection in period 2.
Outcomes	Primary outcomes: Clinical remission (average daily SF and average daily AP at week 12) Endoscopic response (SES‐CD at week 12) Secondary outcomes: Clinical response (average daily SF and average daily AP at week 4 and week 12) Clinical remission (CDAI at week 4 and week 12) Clinical response and endoscopic response (at week 12) Endoscopic healing (SES‐CD at week 12) Severity of Crohn's disease symptoms (Crohn's Symptom Severity at week 12) Resolution of extra‐intestinal manifestation (at week 12) Hospitalisation (through to week 12) Draining fistula (at week 12) Fatigue (FACIT‐F at week 12) Overall health status (SF‐36 at week 12) Crohn's disease‐related surgeries (through to week 12)
Starting date	June 2017
Contact information	AbbVie Call Center Telephone: 8472838955 Email: abbvieclinicaltrials@abbvie.com
Notes	Estimated study completion date: June 2019 Estimated enrollment: 579 participants