Sponsor:
Takeda
Code:
NCT06045754
Conditions
Crohn's Disease
Eligibility Criteria
Sex: All
Age: 18 - 70
Healthy Volunteers: Not accepted
Interventions
Vedolizumab
Adalimumab
Ustekinumab
Ustekinumab
Brief summary:
Conditions
Crohn's Disease
Study ID
NCT06045754
Start date
Apr 18, 2024
Status verified date
Aug, 2026
Completion date
Jun 28, 2027
Anticipated
Primary completion date
Jun 28, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 18 - 70
Healthy Volunteers: Not accepted
Enrollment
50 participants
Anticipated
Allocation
Non randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
experimental: Part A, Cohort 1: Vedolizumab + Adalimumab
experimental: Part A, Cohort 2: Vedolizumab + Ustekinumab
experimental: Part B: Vedolizumab Monotherapy
Interventions
Vedolizumab
Adalimumab
Ustekinumab
Ustekinumab
Primary outcome measure
Central contacts
Locations
Digestive Health Specialsits
Recruiting
Dothan, Alabama, United States, 36301
Contacts
Principal Investigator:
Robert Albares
GI Alliance Sun City
Recruiting
Sun City, Arizona, United States, 85351
Contacts
Principal Investigator:
Chirag Trivedi
University of California San Diego Health (UCSD)
Recruiting
La Jolla, California, United States, 92037
Contacts
Principal Investigator:
Preetika Sinh
Cedars-Sinai Medical Center
Recruiting
Los Angeles, California, United States, 90048
Contacts
Principal Investigator:
Andres Yarur
Hoag Hospital Newport Beach
Recruiting
Newport Beach, California, United States, 92663
Contacts
Principal Investigator:
Caroline Hwang
Medical Research Center of Connecticut, LLC
Recruiting
Hamden, Connecticut, United States, 06518
Contacts
Principal Investigator:
Paul Feuerstadt
Clinical Research of Osceola
Recruiting
Kissimmee, Florida, United States, 34741
Contacts
Principal Investigator:
Basher Atiquzzaman
Endoscopic Research Inc
Recruiting
Orlando, Florida, United States, 32803
Contacts
Principal Investigator:
Henry Levine
Alliance Clinical Research of Tampa, LLC
Recruiting
Tampa, Florida, United States, 33615
Contacts
Principal Investigator:
Israel Crespo
Gastroenterology Consultants, P.C.
Recruiting
Roswell, Georgia, United States, 30076
Contacts
Principal Investigator:
Melvin Bullock
University of Chicago Medicine
Recruiting
Chicago, Illinois, United States, 60637
Contacts
Principal Investigator:
David Rubin
University of Kansas Medical Center
Recruiting
Kansas City, Kansas, United States, 66160
Contacts
Principal Investigator:
Tuba Esfandyari
Cotton ONeil Clinical Research Center
Recruiting
Topeka, Kansas, United States, 66606
Contacts
Principal Investigator:
Curtis Baum
University of Louisville
Recruiting
Louisville, Kentucky, United States, 40202
Contacts
Principal Investigator:
Gerald Dryden
GI Alliance
Recruiting
Metairie, Louisiana, United States, 70006
Contacts
Principal Investigator:
George Catinis
Tulane University
Recruiting
New Orleans, Louisiana, United States, 70112
Contacts
Principal Investigator:
Sarah Glover
Huron Gastroenterology Associates, P.C.
Recruiting
Ypsilanti, Michigan, United States, 48197
Contacts
Principal Investigator:
Najm Soofi
Mid-America Gastro-Intestinal Consultants
Recruiting
Kansas City, Missouri, United States, 64111
Contacts
Principal Investigator:
Hillary Bownik
BVL Clinical Research
Recruiting
Liberty, Missouri, United States, 64068
Contacts
Principal Investigator:
Christopher Bartalos
Washington University School of Medicine
Recruiting
St Louis, Missouri, United States, 63110
Contacts
Principal Investigator:
Parakkal Deepak
NYU Langone Health
Recruiting
New York, New York, United States, 10016
Contacts
Principal Investigator:
David Hudesman
University of Cincinnati
Recruiting
Cincinnati, Ohio, United States, 45627
Contacts
Principal Investigator:
Loren Brook
Ohio Gastroenterology group, Inc.
Recruiting
Columbus, Ohio, United States, 43202
Contacts
Principal Investigator:
Ryan Gaible
Great Lakes Gastroenterology Research, LLC
Recruiting
Mentor, Ohio, United States, 44060
Contacts
Principal Investigator:
Keith Alan Friedenberg
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Recruiting
Westlake, Ohio, United States, 44145
Contacts
Principal Investigator:
Mohamed S Naem
Digestive Disease Specialists, Inc.
Recruiting
Oklahoma City, Oklahoma, United States, 73114
Contacts
Principal Investigator:
David Stokesberry
Allegheny Health Network
Recruiting
Wexford, Pennsylvania, United States, 15090
Contacts
Principal Investigator:
Aakash Desai
University Gastroenterology
Recruiting
Providence, Rhode Island, United States, 02094
Contacts
Principal Investigator:
Ferreira Jason
Sanford Health Research
Recruiting
Rapid City, South Dakota, United States, 57701
Contacts
Principal Investigator:
Blake Jones
Texas Digestive Disease Consultants Cedar Park
Recruiting
Cedar Park, Texas, United States, 78613
Contacts
Principal Investigator:
Junaid Siddiqui
GI Alliance - Digestive Health Associates of Texas
Recruiting
Dallas, Texas, United States, 75044
Contacts
Principal Investigator:
Harry E. Sarles
The University of Texas Health Science Center at Houston
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
Andrew Dupont
Texas Digestive Disease Consultants Lubbock
Recruiting
Lubbock, Texas, United States, 79410
Contacts
Principal Investigator:
Adam Hughston
GI Alliance - Mansfield
Recruiting
Mansfield, Texas, United States, 76063
Contacts
Principal Investigator:
Moustafa Youssef
Gastroenterology Research of San Antonio, LLC
Recruiting
San Antonio, Texas, United States, 78229
Contacts
Principal Investigator:
Nicholas Martinez
Southern Star Research Institute, LLC.
Recruiting
San Antonio, Texas, United States, 78229
Contacts
Principal Investigator:
Jeff Bullock
Texas Digestive Disease Consultants (TDDC), Southlake
Recruiting
Southlake, Texas, United States, 76092
Contacts
Principal Investigator:
Timothy Ritter
Tyler Research Institute, LLC
Recruiting
Tyler, Texas, United States, 75701
Contacts
Principal Investigator:
George Aaron DuVall
GI Alliance - Webster
Recruiting
Webster, Texas, United States, 77598
Contacts
Principal Investigator:
Nikhil Inamdar
University of Utah Health
Recruiting
Salt Lake City, Utah, United States, 84108
Contacts
Site Contact
john.valentine@hsc.utah.eduPrincipal Investigator:
John Valentine
Washington Gastroenterology- GIA
Recruiting
Tacoma, Washington, United States, 98405
Contacts
Principal Investigator:
William Holderman
Covenant Health
Recruiting
Edmonton, Alberta, Canada, T5K 2K4
Contacts
Principal Investigator:
Jesse Siffledeen
London Health Sciences Centre
Recruiting
London, Ontario, Canada, N6A 5A5
Contacts
Principal Investigator:
Vipul Jairath
Viable Clinical Research - North Bay
Recruiting
North Bay, Ontario, Canada, P1B 2H3
Contacts
Principal Investigator:
Stephane Gauthier
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
Recruiting
North York, Ontario, Canada, M6A3B4
Contacts
Principal Investigator:
Mark Silverberg
ABP Research Services Corp.
Recruiting
Oakville, Ontario, Canada, L6L 5L7
Contacts
Principal Investigator:
Bair Douglas
Toronto Digestive Disease Associates (TDDA) Inc.
Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Contacts
Principal Investigator:
Lee Roth
The Research Institute of the McGill University Health Centre
Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contacts
Principal Investigator:
Talat Bessissow
Sponsor
Takeda
Last update posted
Aug 31, 2026
Last verified
Aug, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Takeda on 2026-08-31.