Sponsor:
Takeda
Code:
NCT06227910
Conditions
Crohn's Disease
Eligibility Criteria
Sex: All
Age: 18 - 65
Healthy Volunteers: Not accepted
Interventions
Vedolizumab
Upadacitinib
Placebo
Brief summary:
Conditions
Crohn's Disease
Study ID
NCT06227910
Start date
Jan 2, 2025
Status verified date
May, 2026
Completion date
Aug 1, 2028
Anticipated
Primary completion date
Jun 8, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 18 - 65
Healthy Volunteers: Not accepted
Enrollment
396 participants
Anticipated
Allocation
Randomized
Intervention Model
Sequential
Primary purpose
Treatment
Arms
experimental: Double-blind Induction Phase: Vedolizumab + Upadacitinib
placebo comparator: Double-blind Induction Phase: Vedolizumab + Placebo
experimental: Main Study Maintenance Phase: Vedolizumab Monotherapy
Interventions
Vedolizumab
Upadacitinib
Placebo
Primary outcome measure
Central contacts
Locations
Peak Gastroenterology Associates
Recruiting
Colorado Springs, Colorado, United States, 80907
Contacts
Principal Investigator:
Bhaktasharan Patel
Southern Star Research Institute, LLC
Recruiting
San Antonio, Texas, United States, 78229
Contacts
Principal Investigator:
Jeff Bullock
Tyler Research Institute, LLC
Recruiting
Tyler, Texas, United States, 75701
Contacts
Principal Investigator:
George Duvall
Barrie GI Associates
Recruiting
Barrie, Ontario, Canada, L4M 7G1
Contacts
Principal Investigator:
Rima Petroniene
Taunton Surgical Centre-Oshawa Clinic
Recruiting
Oshawa, Ontario, Canada, L1J 0C7
Contacts
Principal Investigator:
Daniel Green
Toronto Immune and Digestive Health Institute (TIDHI)
Recruiting
Toronto, Ontario, Canada, M6A 3B4
Contacts
Principal Investigator:
Mark Silverberg
Sponsor
Takeda
Last update posted
May 27, 2026
Last verified
May, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Takeda on 2026-05-27.