A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Start Date
4/18/2024
Completion Date
6/28/2027
Summary
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.
Detailed Description
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderate to severe Crohn's disease who have experienced inadequate response, loss of response or intolerance to either one prior interleukin \[IL\] antagonist, and no other biologic/small molecule (Group A); one IL antagonist and either one Janus kinase inhibitor (JAKi) or one TNFi (other than adalimumab) \[Group B\] (Cohort 1) or one prior tumor necrosis factor inhibitor \[TNFi\] and no other biologic/small molecule (Group C); one TNFi and either 1 JAKi or one IL antagonist (other than UST) (Group D) (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy. The study will enroll approximately 100 participants. Participants will be assigned to one of the two treatment groups in Part A: * Part A, Cohort 1: Vedolizumab + Adalimumab * Part A, Cohort 2: Vedolizumab + Ustekinumab All participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug). This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
Vedolizumab
Adalimumab
Ustekinumab
Ustekinumab
Conditions
Locations
Digestive Health Specialsits
Dothan, Alabama 36301
United States
GI Alliance Sun City
Sun City, Arizona 85351
United States
University of California San Diego Health (UCSD)
La Jolla, California 92037
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Hoag Hospital Newport Beach
Newport Beach, California 92663
United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
United States
Clinical Research of Osceola
Kissimmee, Florida 34741
United States
Endoscopic Research Inc
Orlando, Florida 32803
United States
Alliance Clinical Research of Tampa, LLC
Tampa, Florida 33615
United States
Gastroenterology Consultants, P.C.
Roswell, Georgia 30076
United States
University of Chicago Medicine
Chicago, Illinois 60637
United States
GI Alliance - Illinois Gastroenterology Group - Glenview
Glenview, Illinois 60026
United States
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Gurnee, Illinois 60031
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Cotton ONeil Clinical Research Center
Topeka, Kansas 66606
United States
University of Louisville
Louisville, Kentucky 40202
United States
GI Alliance
Metairie, Louisiana 70006
United States
Tulane University
New Orleans, Louisiana 70112
United States
Huron Gastroenterology Associates, P.C.
Ypsilanti, Michigan 48197
United States
Mid-America Gastro-Intestinal Consultants
Kansas City, Missouri 64111
United States
BVL Clinical Research
Liberty, Missouri 64068
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
NYU Langone Health
New York, New York 10016
United States
University of Cincinnati
Cincinnati, Ohio 45627
United States
Ohio Gastroenterology group, Inc.
Columbus, Ohio 43202
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United States
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Westlake, Ohio 44145
United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma 73114
United States
Allegheny Health Network
Wexford, Pennsylvania 15090
United States
University Gastroenterology
Providence, Rhode Island 02094
United States
Sanford Health Research
Rapid City, South Dakota 57701
United States
Texas Digestive Disease Consultants Cedar Park
Cedar Park, Texas 78613
United States
GI Alliance - Digestive Health Associates of Texas
Dallas, Texas 75044
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
Texas Digestive Disease Consultants Lubbock
Lubbock, Texas 79410
United States
GI Alliance - Mansfield
Mansfield, Texas 76063
United States
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas 78229
United States
Southern Star Research Institute, LLC.
San Antonio, Texas 78229
United States
Texas Digestive Disease Consultants (TDDC), Southlake
Southlake, Texas 76092
United States
Tyler Research Institute, LLC
Tyler, Texas 75701
United States
GI Alliance - Webster
Webster, Texas 77598
United States
University of Utah Health
Salt Lake City, Utah 84108
United States
Washington Gastroenterology- GIA
Bellevue, Washington 98004
United States
Washington Gastroenterology- GIA
Tacoma, Washington 98405
United States
Covenant Health
Edmonton, Alberta T5K 2K4
Canada
London Health Sciences Centre
London, Ontario N6A 5A5
Canada
West GTA Endoscopy Inc.
Mississauga, Ontario L5M 7N4
Canada
Viable Clinical Research - North Bay
North Bay, Ontario P1B 2H3
Canada
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
North York, Ontario M6A3B4
Canada
ABP Research Services Corp.
Oakville, Ontario L6L 5L7
Canada
Taunton Surgical Centre
Oshawa, Ontario L1J 0C7
Canada
Toronto Digestive Disease Associates (TDDA) Inc.
Vaughan, Ontario L4L 4Y7
Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec H3G 1A4
Canada