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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: Recruiting Phase 3 study of Crohn's Disease, sponsored by Takeda.

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 2,391-participant average among 105 other Crohn's Disease trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Clinical remission is defined as a CDAI score of less than (\<) 150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

Conditions Studied

Crohn's Disease

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

FieldValue
Enrollment Target 396 participants
Start Date 2025-01-02
Est. Completion 2028-08-01
Phase Phase 3
Takeda

408 total trials

What NCT06227910 shows while recruiting

NCT06227910 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, below the 2,391-participant average among 105 other Crohn's Disease trials with a reported enrollment target (83% lower).

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 names 20 study sites across 12 states, led by 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.

Learn More About Clinical Trials

Similar trials for Crohn's Disease

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.

Where NCT06227910's enrollment target sits among peer trials

396 29th of 105 higher than 77 of 105 other Crohn's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06227910

Source: ClinicalTrials.gov NCT06227910, the US trial registry maintained by the National Library of Medicine. NCT06227910 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.