Vanderbilt Clinical Trials

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 Sex: 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
Placebo Comparator Substudy 1, Induction Period 1: Double-blind Placebo IV	Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.	Drug: placebo for risankizumab placebo for risankizumab
Experimental Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV	Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066
Experimental Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV	Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066
Experimental Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV	Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066
Experimental Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV	Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066
Experimental Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC	Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.	Drug: risankizumab SC risankizumab subcutaneous (SC) injection Other names: ABBV-066 BI 655066
Experimental Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC	Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.	Drug: risankizumab SC risankizumab subcutaneous (SC) injection Other names: ABBV-066 BI 655066
Experimental Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV	Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066
Experimental Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo	Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066
Placebo Comparator Substudy 2, Induction Period 1: Double-blind Placebo IV	Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.	Drug: placebo for risankizumab placebo for risankizumab
Experimental Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV	Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066
Experimental Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC	Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.	Drug: risankizumab SC risankizumab subcutaneous (SC) injection Other names: ABBV-066 BI 655066
Experimental Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC	Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.	Drug: risankizumab SC risankizumab subcutaneous (SC) injection Other names: ABBV-066 BI 655066
Experimental Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV	Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066
Experimental Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo	Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.	Drug: risankizumab IV risankizumab intravenous (IV) infusion Other names: ABBV-066 BI 655066

More Details

Status: Completed
Sponsor: AbbVie