Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04524611 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Crohn's Disease (CD), sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 527
- Enrollment target
- 20
- Study locations
NCT04524611: Active Phase 3 study of Crohn's Disease (CD), sponsored by AbbVie.
NCT04524611 is a Phase 3 study of Crohn's Disease (CD) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 527 participants, above the 100-participant average among 6 other Crohn's Disease (CD) trials with a reported enrollment target (427% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04524611, a Phase 3 study of Crohn's Disease (CD), is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 527 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
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 |
What the registry record for NCT04524611 still lists
NCT04524611 is an interventional study that assigns participants to a tested intervention. The registered 527 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 6 other Crohn's Disease (CD) trials with a reported enrollment target (427% higher).
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.
NCT04524611 names 20 study sites across 6 states, led by Florida, California, Connecticut.
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).
What interventions are being tested in trial NCT04524611?
The interventions under investigation include: Ustekinumab (DRUG), Risankizumab (DRUG).
Who is sponsoring clinical trial NCT04524611?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Crohn's Disease (CD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
RECRUITING · Phase 3
-
Zymfentra (Infliximab-dyyb) REal World Cohort STudy
RECRUITING
-
Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)
RECRUITING · NA
-
Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease
ACTIVE NOT RECRUITING
-
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
COMPLETED · Phase 2
-
Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05373017 · 528 participants · NA
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors
- NCT05634252 · 528 participants · Phase 3
Undergraduate Skin Cancer Prevention Trial
- NCT06383273 · 528 participants · Phase 3
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
- NCT06470243 · 528 participants · Phase 3
Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI