NCT03398148.
| Trial name or title | A multicenter, randomized, double‐blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in subjects with moderately to severely active ulcerative colitis who have failed prior biologic therapy |
| Methods | A multicentre, randomised, double‐blind, placebo‐controlled induction study |
| Participants | 720 participants (aged 16 to <= 80 years) with a confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline, active UC and intolerance or inadequate response to one or more biologic therapies |
| Interventions | Experimental: Substudy 1, induction 2: Double‐blind risankizumab dose 2: Participants who received risankizumab with inadequate response in induction 1 randomised to receive risankizumab dose 2 administered by subcutaneous (SC) injection in induction 2 Experimental: Substudy 2, induction 1: Open‐label risankizumab dose 2: Participants randomised to receive risankizumab dose 2 administered by intravenous (IV) infusion Experimental: Substudy 2, induction 2: Double‐blind risankizumab dose 1(a): Participants who received placebo with inadequate response in induction 1 randomised to receive risankizumab dose 1 administered by intravenous (IV) infusion in induction 2 Experimental: Substudy 2, induction 2: Double‐blind risankizumab dose 3: Participants who received risankizumab with inadequate response in induction 1 randomised to receive risankizumab dose 3 administered by subcutaneous (SC) injection in induction 2 Experimental: Substudy 1, induction 1: Double‐blind risankizumab dose 1: Participants randomised to receive risankizumab dose 1 administered by intravenous (IV) infusion Experimental: Substudy 1, induction 1: Double‐blind risankizumab dose 2: Participants randomised to receive risankizumab dose 2 administered by intravenous (IV) infusion Experimental: Substudy 1, induction 2: Double‐blind risankizumab dose 1(a): Participants who received placebo with inadequate response in induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in induction 2 Experimental: Substudy 1, induction 2: Double‐blind risankizumab dose 1(b): Participants who received risankizumab with inadequate response in induction 1 randomised to receive risankizumab dose 1 administered by intravenous (IV) infusion in induction 2 Experimental: Substudy 2, induction 1: Double‐blind risankizumab dose 1: Participants randomised to receive risankizumab dose 1 administered by intravenous (IV) infusion Experimental: Substudy 1, induction 1: Double‐blind risankizumab dose 3: Participants randomised to receive risankizumab dose 3 administered by intravenous (IV) infusion Placebo Comparator: Substudy 1, induction 1: Double‐blind placebo: Participants randomised to receive placebo for risankizumab administered by intravenous (IV) infusion Experimental: Substudy 2, induction 2: Double‐blind risankizumab dose 2: Participants who received risankizumab with inadequate response in induction 1 randomised to receive risankizumab dose 2 administered by subcutaneous (SC) injection in induction 2 Experimental: Substudy 1, induction 2: Double‐blind risankizumab dose 3: Participants who received risankizumab with inadequate response in induction 1 randomised to receive risankizumab dose 3 administered by subcutaneous (SC) injection in induction 2 Placebo Comparator: Substudy 2, induction 1: Double‐blind placebo: Participants randomised to receive placebo for risankizumab administered by intravenous (IV) infusion Experimental: Substudy 2, induction 2: Double‐blind risankizumab dose 1(b): Participants who received risankizumab with inadequate response in induction 1 randomised to receive risankizumab dose 1 administered by intravenous (IV) infusion in induction 2 Experimental: Substudy 1, induction 1: Open‐label risankizumab dose 3: Participants receive risankizumab dose 3 administered by intravenous (IV) infusion |
| Outcomes | Primary outcomes: Clinical remission (Mayo score at week 12) Secondary outcomes: Clinical remission (full Mayo score at week 12) Severity of Crohn's symptoms (Ulcerative Colitis Symptom Questionnaire (UC‐SQ) at week 12) Quality of life (IBDQ at week 12) Fatigue (FACIT‐Fatigue at week 12) Clinical response (adapted Mayo score at week 12) Endoscopic remission (endoscopy subscore at week 12) Clinical response (partial adapted Mayo score at week 4) Mucosal healing (endoscopic and histologic remission at week 12) Health status (SF‐36 at week 12) Hospitalisation (through week 12) Ulcerative Colitis (UC)‐related surgeries (through week 12) Endoscopic improvement (endoscopy subscore at week 12) |
| Starting date | March 2018 |
| Contact information | AbbVie Call centre Telephone: 847.283.8955 Email: abbvieclinicaltrials@abbvie.com |
| Notes | Estimated study completion date: December 2021 Estimated enrollment: 720 participants |