Actively Recruiting
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Led by Takeda · Updated on 2026-03-18
100
Participants Needed
54
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
Part A:
-
Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.
-
Has moderately to severely active CD at Screening, defined as an SES-CD >=6 (>=4 if isolated ileal disease).
-
Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:
- Inadequate response after completing the full induction regimen;
- Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
- Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).
Note: Participants with an inadequate response to >2 classes of advanced therapies or >1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor.
Part B:
-
In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.
You will not qualify if you...
- CDAI score > 450.
- A current diagnosis of ulcerative colitis or indeterminate colitis.
- Clinical evidence of an abdominal abscess.
- Known fistula (other than perianal fistula) or phlegmon.
- Known perianal fistula with abscess.
- Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
- Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Short bowel syndrome.
- Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.
- History or evidence of adenomatous colonic polyps that have not been removed.
- History or evidence of colonic mucosal dysplasia.
- Intolerance or contraindication to ileocolonoscopy.
- Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection).
- Active or latent tuberculosis (TB), regardless of treatment history.
- A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.
- A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).
- Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181], anti- mucosal addressin cell adhesion molecule-1 [MAdCAM-1] antibodies, or rituximab) for the treatment of CD.
- History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. If a participant has symptoms consistent with PML, a PML checklist must be completed and submitted to the PML independent adjudication committee. If the PML IAC deems the participant to have PML, the participant is ineligible.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 54 locations
1
Digestive Health Specialsits
Dothan, Alabama, United States, 36301
Actively Recruiting
2
GI Alliance Sun City
Sun City, Arizona, United States, 85351
Actively Recruiting
3
University of California San Diego Health (UCSD)
La Jolla, California, United States, 92037
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
Hoag Hospital Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
6
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
Actively Recruiting
7
Clinical Research of Osceola
Kissimmee, Florida, United States, 34741
Actively Recruiting
8
Endoscopic Research Inc
Orlando, Florida, United States, 32803
Actively Recruiting
9
University of South Florida
Tampa, Florida, United States, 33612
Not Yet Recruiting
10
Alliance Clinical Research of Tampa, LLC
Tampa, Florida, United States, 33615
Actively Recruiting
11
Gastroenterology Consultants, P.C.
Roswell, Georgia, United States, 30076
Actively Recruiting
12
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
13
GI Alliance - Illinois Gastroenterology Group - Glenview
Glenview, Illinois, United States, 60026
Actively Recruiting
14
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Gurnee, Illinois, United States, 60031
Actively Recruiting
15
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
16
Cotton ONeil Clinical Research Center
Topeka, Kansas, United States, 66606
Actively Recruiting
17
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
18
GI Alliance
Metairie, Louisiana, United States, 70006
Actively Recruiting
19
Tulane University
New Orleans, Louisiana, United States, 70112
Actively Recruiting
20
Huron Gastroenterology Associates, P.C.
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
21
Mid-America Gastro-Intestinal Consultants
Kansas City, Missouri, United States, 64111
Actively Recruiting
22
BVL Clinical Research
Liberty, Missouri, United States, 64068
Actively Recruiting
23
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
24
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
25
University of Cincinnati
Cincinnati, Ohio, United States, 45627
Actively Recruiting
26
Ohio Gastroenterology group, Inc.
Columbus, Ohio, United States, 43202
Actively Recruiting
27
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
Actively Recruiting
28
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Westlake, Ohio, United States, 44145
Actively Recruiting
29
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, United States, 73114
Actively Recruiting
30
Allegheny Health Network
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
31
University Gastroenterology
Providence, Rhode Island, United States, 02905
Actively Recruiting
32
Rapid City Medical Center, LLP
Rapid City, South Dakota, United States, 57701
Actively Recruiting
33
Texas Digestive Disease Consultants Cedar Park
Cedar Park, Texas, United States, 78613
Actively Recruiting
34
GI Alliance - Digestive Health Associates of Texas
Dallas, Texas, United States, 75044
Actively Recruiting
35
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
36
Texas Digestive Disease Consultants Lubbock
Lubbock, Texas, United States, 79410
Actively Recruiting
37
GI Alliance - Mansfield
Mansfield, Texas, United States, 76063
Actively Recruiting
38
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
39
Southern Star Research Institute, LLC.
San Antonio, Texas, United States, 78229
Actively Recruiting
40
Texas Digestive Disease Consultants (TDDC), Southlake
Southlake, Texas, United States, 76092
Actively Recruiting
41
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
Actively Recruiting
42
GI Alliance - Webster
Webster, Texas, United States, 77598
Actively Recruiting
43
University of Utah Health
Salt Lake City, Utah, United States, 84108
Actively Recruiting
44
Washington Gastroenterology- GIA
Bellevue, Washington, United States, 98004
Withdrawn
45
Washington Gastroenterology- GIA
Tacoma, Washington, United States, 98405
Actively Recruiting
46
Covenant Health
Edmonton, Alberta, Canada, T5K 2K4
Actively Recruiting
47
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Actively Recruiting
48
West GTA Endoscopy Inc.
Mississauga, Ontario, Canada, L5M 7N4
Actively Recruiting
49
Viable Clinical Research - North Bay
North Bay, Ontario, Canada, P1B 2H3
Actively Recruiting
50
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
North York, Ontario, Canada, M6A3B4
Actively Recruiting
51
ABP Research Services Corp.
Oakville, Ontario, Canada, L6L 5L7
Actively Recruiting
52
Taunton Surgical Centre
Oshawa, Ontario, Canada, L1J 0C7
Withdrawn
53
Toronto Digestive Disease Associates (TDDA) Inc.
Vaughan, Ontario, Canada, L4L 4Y7
Actively Recruiting
54
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here