ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT04524611

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.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:47 AM EDT

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

Study identification

NCT ID
NCT04524611
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AbbVie
Industry
Enrollment
527 participants

Conditions and interventions

Conditions

Not listed

Interventions

Not listed

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 29, 2020
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028
Last update posted
Apr 12, 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 43 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 12, 2026 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04524611 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →