A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (NCT03398135)
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Who can join: Review the eligibility criteria below.
Location: Southern California Res. Ctr. /ID# 169659 — Coronado, California
Age range: 16 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (426 Sites)
Showing the first 25 of 426 sites.
- Southern California Res. Ctr. /ID# 169659 — Coronado, California
- Hoag Memorial Hosp Presbyterian /ID# 218347 — Irvine, California
- UC San Diego Health System /ID# 160430 — La Jolla, California
- United Medical Doctors /ID# 158574 — Los Alamitos, California
- Cedars-Sinai Medical Center /ID# 163848 — Los Angeles, California
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934 — Los Angeles, California
- UCSF Medical Center - Mount Zion /ID# 201209 — San Francisco, California
- Peak Gastroenterology Associates, PC /ID# 165838 — Colorado Springs, Colorado
- Rocky Mountain Pediatric Gastroenterology /ID# 207173 — Lone Tree, Colorado
- Duplicate_Medical Research Center of CT /ID# 160287 — Hamden, Connecticut
- Yale Univ Digestive Diseases /ID# 213265 — New Haven, Connecticut
- South Lake Pain Institute, Inc /ID# 162859 — Clermont, Florida
- Ctr for Advanced Gastroenterol /ID# 202820 — Maitland, Florida
- University of Miami /ID# 160456 — Miami, Florida
- Coral Research Clinic /ID# 158608 — Miami, Florida
- South Florida Research Ph I-IV, Inc. /ID# 161844 — Miami, Florida
- Gastroenterology Group Naples /ID# 165210 — Naples, Florida
- Advanced Research Institute, Inc /ID# 161945 — New Port Richey, Florida
- Advent Health /ID# 160393 — Orlando, Florida
- Endoscopic Research, Inc. /ID# 206709 — Orlando, Florida
- Omega Research Group /ID# 203105 — Orlando, Florida
- Duplicate_Lenus Research & Medical Group /ID# 169727 — Sweetwater, Florida
- Clinical Research Trials of Florida, Inc. /ID# 201794 — Tampa, Florida
- Duplicate_AdventHealth Tampa /ID# 170482 — Tampa, Florida
- Gastroenterology Associates of Central Georgia, LLC /ID# 160513 — Macon, Georgia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis (UC)
- Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants — Miami, Florida
- A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC) — Birmingham, Alabama
- A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) — Mobile, Alabama
- Using Breath Tests to Study Gut Sulfur Changes During Dietary Therapy — Kelowna, British Columbia
- A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis — Miami, Florida
Explore by condition: All Ulcerative Colitis (UC) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.