A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Public ClinicalTrials.gov record NCT06227910. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06227910
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 396 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2025
- Primary completion
- Jun 7, 2027
- Completion
- Jul 31, 2028
- Last update posted
- May 26, 2026
2025 – 2028
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD Medical Center | La Jolla | California | 92037 | Not yet recruiting |
| Keck Medicine Of USC - USC Healthcare Center 1 | Los Angeles | California | 90033 | Not yet recruiting |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | Recruiting |
| GI PROS, Inc. | Naples | Florida | 34102 | Active, not recruiting |
| Orlando Health Ambulatory Care Center | Orlando | Florida | 32806 | Active, not recruiting |
| USF Health Morsani Center for Advanced Healthcare | Tampa | Florida | 33612 | Active, not recruiting |
| Indiana University (IU) Health University Hospital | Indianapolis | Indiana | 46202 | Active, not recruiting |
| University of Kentucky | Lexington | Kentucky | 40536 | Active, not recruiting |
| Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center | New York | New York | 10029-5204 | Active, not recruiting |
| Columbia University Medical Center, New York-Presbyterian Hospital | New York | New York | 10032 | Not yet recruiting |
| Lenox Hill Hospital Northwell Health | New York | New York | 10075 | Active, not recruiting |
| Gastroenterology Associates | Greenville | South Carolina | 29607 | Active, not recruiting |
| Rapid City Medical Center | Rapid City | South Dakota | 57701 | Active, not recruiting |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | Recruiting |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | Recruiting |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | Active, not recruiting |
| Swedish Cancer Institute | Seattle | Washington | 98104 | Not yet recruiting |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | Not yet recruiting |
| Medical College of Wisconsin Cancer Center - Froedtert Hospital | Milwaukee | Wisconsin | 53226 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 119 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06227910, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 26, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06227910 live on ClinicalTrials.gov.