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A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
NCT06227910 · View on ClinicalTrials.gov ↗
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 |
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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. 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 396 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 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 appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT06227910 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New York, Washington. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06227910?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG), Vedolizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06227910?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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