A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Purpose
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Condition
- Ulcerative Colitis (UC)
Eligibility
- Eligible Ages
- Between 16 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit. - Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline. - Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore. - Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies. - Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.
Exclusion Criteria
- Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis. - Participant receiving prohibited medications and treatment. - Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. - Participant with currently known complications of UC (e.g., megacolon). - No known active Coronavirus Disease - 2019 (COVID-19) infection.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Substudy 1, Induction 1: Double-blind Risankizumab Dose 1 |
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion. |
|
Experimental Substudy 1, Induction 1: Double-blind Risankizumab Dose 2 |
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion. |
|
Experimental Substudy 1, Induction 1: Double-blind Risankizumab Dose 3 |
Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion. |
|
Placebo Comparator Substudy 1, Induction 1: Double-blind Placebo |
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion. |
|
Experimental Substudy 1, Induction 1: Open-label Risankizumab Dose 1 |
Participants receive risankizumab dose 1 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 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2. |
|
Experimental Substudy 1, Induction 2: Double-blind Risankizumab Dose 2 |
Participants who received risankizumab with inadequate response in Induction 1 randomized 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 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2. |
|
Experimental Substudy 2, Induction 1: Double-blind Risankizumab Dose 1 |
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion. |
|
Placebo Comparator Substudy 2, Induction 1: Double-blind Placebo |
Participants randomized to receive placebo for risankizumab 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 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2. |
|
Experimental Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b) |
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2. |
|
Experimental Substudy 2, Induction 2: Double-blind Risankizumab Dose 2 |
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2. |
|
Experimental Substudy 2, Induction 2: Double-blind Risankizumab Dose 3 |
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2. |
|
More Details
- Status
- Completed
- Sponsor
- AbbVie