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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT06227910

Run by

Takeda

People needed

396

Starts

2025-01-02

Expected to finish

2028-08-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.
• The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
• The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score of >=6 (or >=4 for participants with isolated ileal disease), as confirmed by a central reader.
• The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.

You may not qualify if…

• The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
• The participant has infection(s) requiring treatment with IV anti-infectives within 30 days prior to baseline or oral/intramuscular anti-infectives within 14 days prior to baseline.
• The participant has evidence of an active infection during the screening period, or clinically significant infection within 30 days prior to screening, or ongoing chronic infection.
• The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
• The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.
• The participant has an ostomy or ileoanal pouch.
• The participant has severe renal impairment, defined as an estimated glomerular filtration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
• The participant has severe (Child-Pugh C) hepatic impairment.

Where it is running

• Tyler Research Institute, LLC — Tyler, Texas, United States (enrolling)
• Inje University Haeundae Paik Hospital — Busan, South Korea (enrolling)
• Kyung Hee University Hospital — Seoul, South Korea (enrolling)
• Barrie GI Associates — Barrie, Ontario, Canada (enrolling)
• Southern Star Research Institute, LLC — San Antonio, Texas, United States (enrolling)
• Taunton Surgical Centre-Oshawa Clinic — Oshawa, Ontario, Canada (enrolling)
• Toronto Immune and Digestive Health Institute (TIDHI) — Toronto, Ontario, Canada (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• Indiana University (IU) Health University Hospital — Indianapolis, Indiana, United States
• Krankenhaus der Barmherzigen Brueder Wien — Vienna, Austria
• Gastroenterology Associates — Greenville, South Carolina, United States
• Rapid City Medical Center — Rapid City, South Dakota, United States
• USF Health Morsani Center for Advanced Healthcare — Tampa, Florida, United States
• Lenox Hill Hospital Northwell Health — New York, New York, United States
• Columbia University Medical Center, New York-Presbyterian Hospital — New York, New York, United States
• Orlando Health Ambulatory Care Center — Orlando, Florida, United States
• Medical College of Wisconsin Cancer Center - Froedtert Hospital — Milwaukee, Wisconsin, United States
• University of Washington Medical Center - Montlake — Seattle, Washington, United States
• Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III — Vienna, State of Vienna, Austria
• Medical University Innsbruck — Innsbruck, Tyrol, Austria
• Johannes Kepler Universitat Linz (JKU) — Linz, Austria
• Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss — Salzburg, Austria
• Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center — New York, New York, United States
• Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel — Brussels, Anderlecht, Belgium
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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