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
Completed · Phase 2, Phase 3 · NCT03398148
Conditions: Ulcerative Colitis (UC)
At a glance
- Research payments reported, 2025
- $250
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 1,558
About the trial
- Sponsor
- AbbVie
- Tested
- risankizumab IV (drug), placebo for risankizumab (drug), risankizumab SC (drug)
- Dates
- Started 2018-03-07; completion 2023-05-11
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2025-01-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $250 in research payments for this study in 2025 (1 payments).
Products named: Skyrizi
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Yale University $250
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.