Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) (NCT04524611)
A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
🩺 Plain-English Summary (8th-Grade Level)
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).
Location: Advanced Gastroenterology, P.C /ID# 224396 — Chandler, Arizona
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Current diagnosis of ulcerative colitis or indeterminate colitis.
- Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
- Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
- Currently know complications of CD (strictures, short bowel, etc).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (300 Sites)
Showing the first 25 of 300 sites.
- Advanced Gastroenterology, P.C /ID# 224396 — Chandler, Arizona
- Southern California Res. Ctr. /ID# 223484 — Coronado, California
- Hoag Memorial Hosp Presbyterian /ID# 224373 — Irvine, California
- United Medical Doctors /ID# 223486 — Los Alamitos, California
- TLC Clinical Research Inc /ID# 223467 — Los Angeles, California
- Duplicate_UC Davis Medical Center /ID# 225700 — Sacramento, California
- Duplicate_University of California, San Francisco /ID# 223621 — San Francisco, California
- Duplicate_Western Connecticut Medical Group /ID# 223478 — Danbury, Connecticut
- Duplicate_Medical Research Center of CT /ID# 223540 — Hamden, Connecticut
- Yale Univ Digestive Diseases /ID# 224463 — New Haven, Connecticut
- Omega Research Maitland, LLC /ID# 223463 — DeBary, Florida
- Nature Coast Clinical Research - Inverness /ID# 223600 — Inverness, Florida
- University of Miami /ID# 223496 — Miami, Florida
- Gastroenterology Group Naples /ID# 223516 — Naples, Florida
- Advanced Research Institute, Inc /ID# 223470 — New Port Richey, Florida
- Endoscopic Research, Inc. /ID# 223505 — Orlando, Florida
- Duplicate_University of South Florida /ID# 224733 — Tampa, Florida
- Atlanta Gastro Assoc /ID# 223537 — Atlanta, Georgia
- Gastroenterology Associates of Central Georgia, LLC /ID# 223525 — Macon, Georgia
- Duplicate_The University of Chicago DCAM /ID# 223520 — Chicago, Illinois
- NorthShore University-Endeavor Health Evanston Hospital /ID# 223538 — Evanston, Illinois
- Southwest Gastroenterology /ID# 223509 — Oak Lawn, Illinois
- University of Louisville Hospital /ID# 223471 — Louisville, Kentucky
- GI Alliance /ID# 223508 — Baton Rouge, Louisiana
- Nola Research Works, LLC /ID# 223489 — New Orleans, Louisiana
💰 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 Crohn's Disease (CD)
- A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD) — Phoenix, Arizona
- Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD) — Chapel Hill, North Carolina
- Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD — Cleveland, Ohio
Explore by condition: All Crohn's Disease (CD) 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.