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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 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ustekinumab
- DRUG Risankizumab
Study Locations (20)
Florida
- Omega Research Maitland, LLC /ID# 223463 — DeBary
- Nature Coast Clinical Research - Inverness /ID# 223600 — Inverness
- University of Miami /ID# 223496 — Miami
- Gastroenterology Group Naples /ID# 223516 — Naples
- Advanced Research Institute, Inc /ID# 223470 — New Port Richey
- Endoscopic Research, Inc. /ID# 223505 — Orlando
- Duplicate_University of South Florida /ID# 224733 — Tampa
California
- Southern California Res. Ctr. /ID# 223484 — Coronado
- Hoag Memorial Hosp Presbyterian /ID# 224373 — Irvine
- United Medical Doctors /ID# 223486 — Los Alamitos
- TLC Clinical Research Inc /ID# 223467 — Los Angeles
- Duplicate_UC Davis Medical Center /ID# 225700 — Sacramento
- Duplicate_University of California, San Francisco /ID# 223621 — San Francisco
Connecticut
- Duplicate_Western Connecticut Medical Group /ID# 223478 — Danbury
- Duplicate_Medical Research Center of CT /ID# 223540 — Hamden
- Yale Univ Digestive Diseases /ID# 224463 — New Haven
Georgia
- Atlanta Gastro Assoc /ID# 223537 — Atlanta
- Gastroenterology Associates of Central Georgia, LLC /ID# 223525 — Macon
Arizona
- Advanced Gastroenterology, P.C /ID# 224396 — Chandler
Illinois
- The University of Chicago DCAM /ID# 223520 — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 527 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2028-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04524611
The ClinicalTrials.gov registry entry for NCT04524611 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 527 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Crohn's Disease (CD) appearing as the primary indexed condition, and to 2 interventions — of which Ustekinumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04524611 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04524611 about?
NCT04524611 is a clinical study titled "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)". 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 be...
What is the current status of trial NCT04524611?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 527 participants. The study started on 2020-09-30. Estimated completion is 2028-02.
What conditions does trial NCT04524611 study?
This clinical trial studies the following conditions: Crohn's Disease (CD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04524611?
The interventions under investigation include: Ustekinumab (DRUG), Risankizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04524611?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04524611 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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