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Study identifier: NCT06227910 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Crohn's Disease  ·  Sponsor: Takeda

PhasePhase 3
Planned participants396
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Takeda Contact  ·  +1-877-825-3327  ·  medinfoUS@takeda.com

Always discuss trial participation with your own doctor first.

Locations (138)

UCSD Medical CenterLa Jolla, California, United StatesNot Yet Recruiting
Keck Medicine Of USC - USC Healthcare Center 1Los Angeles, California, United StatesNot Yet Recruiting
Peak Gastroenterology AssociatesColorado Springs, Colorado, United StatesRecruiting
GI PROS, Inc.Naples, Florida, United StatesActive Not Recruiting
Orlando Health Ambulatory Care CenterOrlando, Florida, United StatesActive Not Recruiting
USF Health Morsani Center for Advanced HealthcareTampa, Florida, United StatesActive Not Recruiting
Indiana University (IU) Health University HospitalIndianapolis, Indiana, United StatesActive Not Recruiting
University of KentuckyLexington, Kentucky, United StatesActive Not Recruiting
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical CenterNew York, New York, United StatesActive Not Recruiting
Columbia University Medical Center, New York-Presbyterian HospitalNew York, New York, United StatesNot Yet Recruiting
Lenox Hill Hospital Northwell HealthNew York, New York, United StatesActive Not Recruiting
Gastroenterology AssociatesGreenville, South Carolina, United StatesActive Not Recruiting

+ 126 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06227910