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)
Public ClinicalTrials.gov record NCT04524611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04524611
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 527 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2020 (Actual)
- Primary completion
- Feb 2028 (Estimated)
- Completion
- Feb 2028 (Estimated)
- Last update posted
- Apr 13, 2026
2020 – 2028
United States locations
- U.S. sites
- 72
- U.S. states
- 27
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Gastroenterology, P.C /ID# 224396 | Chandler | Arizona | 85224-1636 | — |
| Southern California Res. Ctr. /ID# 223484 | Coronado | California | 92118-1408 | — |
| Hoag Memorial Hosp Presbyterian /ID# 224373 | Irvine | California | 92618 | — |
| United Medical Doctors /ID# 223486 | Los Alamitos | California | 90720-3309 | — |
| TLC Clinical Research Inc /ID# 223467 | Los Angeles | California | 90048 | — |
| Duplicate_UC Davis Medical Center /ID# 225700 | Sacramento | California | 95817 | — |
| Duplicate_University of California, San Francisco /ID# 223621 | San Francisco | California | 94158 | — |
| Duplicate_Western Connecticut Medical Group /ID# 223478 | Danbury | Connecticut | 06810 | — |
| Duplicate_Medical Research Center of CT /ID# 223540 | Hamden | Connecticut | 06518 | — |
| Yale Univ Digestive Diseases /ID# 224463 | New Haven | Connecticut | 06510 | — |
| Omega Research Maitland, LLC /ID# 223463 | DeBary | Florida | 32713-2260 | — |
| Nature Coast Clinical Research - Inverness /ID# 223600 | Inverness | Florida | 34452-4717 | — |
| University of Miami /ID# 223496 | Miami | Florida | 33136 | — |
| Gastroenterology Group Naples /ID# 223516 | Naples | Florida | 34102 | — |
| Advanced Research Institute, Inc /ID# 223470 | New Port Richey | Florida | 34653 | — |
| Endoscopic Research, Inc. /ID# 223505 | Orlando | Florida | 32803 | — |
| Duplicate_University of South Florida /ID# 224733 | Tampa | Florida | 33612 | — |
| Atlanta Gastro Assoc /ID# 223537 | Atlanta | Georgia | 30342 | — |
| Gastroenterology Associates of Central Georgia, LLC /ID# 223525 | Macon | Georgia | 31201 | — |
| Duplicate_The University of Chicago DCAM /ID# 223520 | Chicago | Illinois | 60637 | — |
| NorthShore University-Endeavor Health Evanston Hospital /ID# 223538 | Evanston | Illinois | 60201 | — |
| Southwest Gastroenterology /ID# 223509 | Oak Lawn | Illinois | 60453 | — |
| University of Louisville Hospital /ID# 223471 | Louisville | Kentucky | 40202 | — |
| GI Alliance /ID# 223508 | Baton Rouge | Louisiana | 70809 | — |
| Nola Research Works, LLC /ID# 223489 | New Orleans | Louisiana | 70115 | — |
| Louisiana Research Center, LLC /ID# 223503 | Shreveport | Louisiana | 71105-6800 | — |
| Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499 | Chevy Chase | Maryland | 20815 | — |
| Gastro Center of Maryland /ID# 223518 | Columbia | Maryland | 21045 | — |
| Massachusetts General Hospital /Id# 224335 | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center /ID# 228094 | Boston | Massachusetts | 02215-5400 | — |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597 | Ann Arbor | Michigan | 48109 | — |
| AA Medical Research Center - Flint /ID# 224384 | Flint | Michigan | 48504 | — |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465 | Wyoming | Michigan | 49519 | — |
| Mayo Clinic - Rochester /ID# 223506 | Rochester | Minnesota | 55905-0001 | — |
| Las Vegas Medical Research /ID# 223533 | Las Vegas | Nevada | 89113 | — |
| Univ New Mexico /ID# 223515 | Albuquerque | New Mexico | 87131 | — |
| NY Scientific /ID# 223479 | Brooklyn | New York | 11235 | — |
| Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048 | Burnt Hills | New York | 12027 | — |
| Intercity Advanced Gastroentertology Center /ID# 224313 | Fresh Meadows | New York | 11366 | — |
| North Shore University Hospital /ID# 224356 | New Hyde Park | New York | 11040 | — |
| The Mount Sinai Hospital /ID# 223687 | New York | New York | 10029 | — |
| Columbia Univ Medical Center /ID# 224215 | New York | New York | 10032-3725 | — |
| Lenox Hill Hospital /ID# 223534 | New York | New York | 10075 | — |
| Univ NC Chapel Hill /ID# 224405 | Chapel Hill | North Carolina | 27514-4220 | — |
| Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 224406 | Winston-Salem | North Carolina | 27157-0001 | — |
| Plains Clinical Research Center, LLC /ID# 223522 | Fargo | North Dakota | 58104-5925 | — |
| University of Cincinnati Medical Center /ID# 224614 | Cincinnati | Ohio | 45219-2364 | — |
| Cleveland Clinic Main Campus /ID# 223691 | Cleveland | Ohio | 44195 | — |
| DSI Research, LLC /ID# 234116 | Springboro | Ohio | 45066-1615 | — |
| Hightower Clinical /ID# 223566 | Oklahoma City | Oklahoma | 73102 | — |
| Digestive Disease Specialists /ID# 223528 | Oklahoma City | Oklahoma | 73112 | — |
| Penn State Milton S. Hershey Medical Center /ID# 224216 | Hershey | Pennsylvania | 17033-2360 | — |
| Guthrie Medical Group, PC /ID# 223910 | Sayre | Pennsylvania | 18840 | — |
| Digestive Disease Associates, LTD - Wyomissing /ID# 223462 | Wyomissing | Pennsylvania | 19610 | — |
| Medical University of South Carolina /ID# 223485 | Charleston | South Carolina | 29425 | — |
| Consultants in Gastroenterology - Columbia NE /ID# 224263 | Columbia | South Carolina | 29203-8902 | — |
| Gastroenterology Associates, P.A. of Greenville /ID# 223497 | Greenville | South Carolina | 29607 | — |
| Gastro One /ID# 223539 | Cordova | Tennessee | 38018 | — |
| Vanderbilt University Medical Center /ID# 224610 | Nashville | Tennessee | 37232-0011 | — |
| Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512 | Dallas | Texas | 75246 | — |
| Duplicate_DHAT Research Institute /ID# 223521 | Garland | Texas | 75044-2208 | — |
| Vilo Research Group Inc /ID# 223513 | Houston | Texas | 77017-2337 | — |
| Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 223488 | Houston | Texas | 77030-3411 | — |
| Clinical Associates in Research Therapeutics of America, LLC /ID# 223510 | San Antonio | Texas | 78212 | — |
| Southern Star Research Institute, LLC /ID# 223598 | San Antonio | Texas | 78229-5390 | — |
| Texas Digestive Disease Consultants - Southlake /ID# 224264 | Southlake | Texas | 76092 | — |
| Tyler Research Institute, LLC /ID# 223469 | Tyler | Texas | 75701 | — |
| University of Vermont Medical Center /ID# 224047 | Burlington | Vermont | 05401-1473 | — |
| Richmond VA Medical Center /ID# 223586 | Richmond | Virginia | 23249 | — |
| Virginia Mason Hospital & Medical Center /ID# 224253 | Seattle | Washington | 98101 | — |
| Harborview Medical Center /ID# 224464 | Seattle | Washington | 98104-2420 | — |
| West Virginia University Hospitals /ID# 223501 | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 228 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04524611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04524611 live on ClinicalTrials.gov.