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A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

NCT06227910

This study is recruiting at 3 US sites in 2 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Crohn's Disease

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
18 to 65 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Takeda
Last updated on ClinicalTrials.gov
May 27, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Colorado · 1

  • Peak Gastroenterology Associates · Colorado Springs, CO

Texas · 2

  • Southern Star Research Institute, LLC · San Antonio, TX
  • Tyler Research Institute, LLC · Tyler, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.