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)

Running, not enrolling · Phase 3

Conditions studied: Crohn's Disease (CD)

In brief

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.

Key facts

Study ID

NCT04524611

Run by

AbbVie

People needed

527

Starts

2020-09-30

Expected to finish

2028-02-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline.
• Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
• Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
• Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.

You may not qualify if…

• 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).

Where it is running

• Southern California Res. Ctr. /ID# 223484 — Coronado, California, United States
• Hoag Memorial Hosp Presbyterian /ID# 224373 — Irvine, California, United States
• United Medical Doctors /ID# 223486 — Los Alamitos, California, United States
• TLC Clinical Research Inc /ID# 223467 — Los Angeles, California, United States
• Duplicate_UC Davis Medical Center /ID# 225700 — Sacramento, California, United States
• Duplicate_University of California, San Francisco /ID# 223621 — San Francisco, California, United States
• Duplicate_Western Connecticut Medical Group /ID# 223478 — Danbury, Connecticut, United States
• Duplicate_Medical Research Center of CT /ID# 223540 — Hamden, Connecticut, United States
• Yale Univ Digestive Diseases /ID# 224463 — New Haven, Connecticut, United States
• Omega Research Maitland, LLC /ID# 223463 — DeBary, Florida, United States
• Nature Coast Clinical Research - Inverness /ID# 223600 — Inverness, Florida, United States
• University of Miami /ID# 223496 — Miami, Florida, United States
• Gastroenterology Group Naples /ID# 223516 — Naples, Florida, United States
• Advanced Research Institute, Inc /ID# 223470 — New Port Richey, Florida, United States
• Endoscopic Research, Inc. /ID# 223505 — Orlando, Florida, United States
• Duplicate_University of South Florida /ID# 224733 — Tampa, Florida, United States
• Atlanta Gastro Assoc /ID# 223537 — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia, LLC /ID# 223525 — Macon, Georgia, United States
• Duplicate_The University of Chicago DCAM /ID# 223520 — Chicago, Illinois, United States
• NorthShore University-Endeavor Health Evanston Hospital /ID# 223538 — Evanston, Illinois, United States
• Southwest Gastroenterology /ID# 223509 — Oak Lawn, Illinois, United States
• University of Louisville Hospital /ID# 223471 — Louisville, Kentucky, United States
• GI Alliance /ID# 223508 — Baton Rouge, Louisiana, United States
• Nola Research Works, LLC /ID# 223489 — New Orleans, Louisiana, United States
• Advanced Gastroenterology, P.C /ID# 224396 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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