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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 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 96-participant average among 5 other Crohn's Disease (CD) trials with a reported enrollment target (449% higher). The trial reports 20 study locations across 6 states.

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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.

Conditions Studied

Crohn's Disease (CD)

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

FieldValue
Enrollment Target 527 participants
Start Date 2020-09-30
Est. Completion 2028-02
Phase Phase 3

Sponsor

AbbVie

526 total trials

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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, categorized as Phase 3. The registered enrollment target is 527 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 96-participant average among 5 other Crohn's Disease (CD) trials with a reported enrollment target (449% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.