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NCT06227910 · ClinicalTrials.gov registry record · Phase 3
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 396
- Enrollment target
- 20
- Study locations
NCT06227910 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Takeda. The registered enrollment target is 396 participants, below the 2,411-participant average among 104 other Crohn's Disease trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT06227910, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 396 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Upadacitinib
- DRUG Vedolizumab
Study Locations (20)
Florida
- GI PROS, Inc. - Naples
- Orlando Health Ambulatory Care Center - Orlando
- USF Health Morsani Center for Advanced Healthcare - Tampa
New York
- Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center - New York
- Columbia University Medical Center, New York-Presbyterian Hospital - New York
- Lenox Hill Hospital Northwell Health - New York
Washington
- Virginia Mason Medical Center - Seattle
- Swedish Cancer Institute - Seattle
- University of Washington Medical Center - Montlake - Seattle
California
- UCSD Medical Center - La Jolla
- Keck Medicine Of USC - USC Healthcare Center 1 - Los Angeles
Texas
- Southern Star Research Institute, LLC - San Antonio
- Tyler Research Institute, LLC - Tyler
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Indiana
- Indiana University (IU) Health University Hospital - Indianapolis
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2025-01-02 |
| Est. Completion | 2028-08-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06227910
The ClinicalTrials.gov registry entry for NCT06227910 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,411-participant average among 104 other Crohn's Disease trials with a reported enrollment target (84% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06227910 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, New York, Washington.
Frequently Asked Questions
What is clinical trial NCT06227910 about?
NCT06227910 is a clinical study titled "A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease". The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease...
What is the current status of trial NCT06227910?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 396 participants. The study started on 2025-01-02. Estimated completion is 2028-08-01.
What conditions does trial NCT06227910 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT06227910?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG), Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT06227910?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06227910 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.