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 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT03398148

Run by

AbbVie

People needed

1558

Starts

2018-03-07

Expected to finish

2023-05-11

Last updated by the study team

2025-01-16

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hoag Memorial Hosp Presbyterian /ID# 218348 — Irvine, California, United States
• UC San Diego Health System /ID# 160452 — La Jolla, California, United States
• United Medical Doctors /ID# 158528 — Los Alamitos, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931 — Los Angeles, California, United States
• UCSF Center for Colitis and Crohn's Disease /ID# 201210 — San Francisco, California, United States
• Cedars-Sinai Medical Center-West Hollywood /ID# 163851 — West Hollywood, California, United States
• Peak Gastroenterology Associates, PC /ID# 165841 — Colorado Springs, Colorado, United States
• Rocky Mountain Pediatric Gastroenterology /ID# 207174 — Lone Tree, Colorado, United States
• Medical Research Center of CT /ID# 160311 — Hamden, Connecticut, United States
• Yale Univ Digestive Diseases /ID# 213179 — New Haven, Connecticut, United States
• South Lake Pain Institute, Inc /ID# 162878 — Clermont, Florida, United States
• Ctr for Advanced Gastroenterol /ID# 202811 — Maitland, Florida, United States
• University of Miami /ID# 160471 — Miami, Florida, United States
• Coral Research Clinic /ID# 158584 — Miami, Florida, United States
• South Florida Research Ph I-IV, Inc. /ID# 161848 — Miami, Florida, United States
• Gastroenterology Group Naples /ID# 165212 — Naples, Florida, United States
• Advanced Research Institute, Inc /ID# 161938 — New Port Richey, Florida, United States
• Advent Health /ID# 160433 — Orlando, Florida, United States
• Endoscopic Research, Inc. /ID# 206711 — Orlando, Florida, United States
• Omega Research Group /ID# 203059 — Orlando, Florida, United States
• Lenus Research & Medical Group /ID# 169730 — Sweetwater, Florida, United States
• Clinical Research Trials of Florida, Inc. /ID# 201783 — Tampa, Florida, United States
• AdventHealth Tampa /ID# 170503 — Tampa, Florida, United States
• Gastroenterology Associates of Central Georgia, LLC /ID# 160523 — Macon, Georgia, United States
• Southern California Res. Ctr. /ID# 169660 — Coronado, California, United States

Full record on ClinicalTrials.gov

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