Actively Recruiting
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
Led by Takeda · Updated on 2026-05-13
400
Participants Needed
98
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.
CONDITIONS
Official Title
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant can understand and follow study requirements
- Signed informed consent and privacy authorization
- Age between 18 and 80 years at consent
- Up-to-date immunizations per Vedolizumab US prescribing information
- For women of childbearing potential: use highly effective contraception during study and for 18 weeks after last dose, negative pregnancy test before first dose, avoid ovum donation and breastfeeding during study and 18 weeks after last dose
- For fertile men: use contraception during study and for 18 weeks after last dose, avoid sperm donation during study and 18 weeks after last dose
- Diagnosis of moderate to severely active UC or CD confirmed by clinical, endoscopic, and histopathology reports
- Inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, or advanced therapy
You will not qualify if you...
- Prior use of approved or investigational anti-integrin antibodies before screening
- Failed more than 2 prior advanced treatments
- Use of corticosteroid enemas or suppositories within 2 weeks before screening
- Contraindications, allergies, or intolerance to Vedolizumab or its components
- Received investigational biologic therapy within 6 months before screening
- Received advanced treatments for conditions other than UC or CD
- Evidence of active infection at screening
- Presence of ileostomy, colostomy, severe or symptomatic intestinal stenosis, or short bowel syndrome
- Major surgery under general anesthesia within 3 months before screening or planned during study
- History of malignancy except certain treated skin cancers and cervical carcinoma in situ
- History or symptoms of progressive multifocal leukoencephalopathy (PML)
- Laboratory abnormalities during screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 98 locations
1
Gastro Health Research- St. Vincents East
Birmingham, Alabama, United States, 35235
Active, Not Recruiting
2
East View Medical Research
Mobile, Alabama, United States, 36608
Actively Recruiting
3
AZ Gastro Care
Chandler, Arizona, United States, 85225
Actively Recruiting
4
Spectrum Research Institute LLC
Gilbert, Arizona, United States, 85297
Actively Recruiting
5
GI Alliance- Sun City
Sun City, Arizona, United States, 85351
Actively Recruiting
6
UAMS Health Gastroenterology Clinic
Little Rock, Arkansas, United States, 72205
Withdrawn
7
Gastroenterology and Liver Institute
Escondido, California, United States, 92025
Actively Recruiting
8
Inland Empire Gastroenterology
Murrieta, California, United States, 92562
Withdrawn
9
United Clinical Research Institute
Murrieta, California, United States, 92563
Active, Not Recruiting
10
Digestive Health Institute
Newport Beach, California, United States, 92663
Withdrawn
11
Knowledge Research Center
Orange, California, United States, 92868
Withdrawn
12
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
Withdrawn
13
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
14
Associates in Gastroenterology, PC
Colorado Springs, Colorado, United States, 80923
Actively Recruiting
15
Rocky Mountain Endocopy Centers LLC
Littleton, Colorado, United States, 80120
Actively Recruiting
16
Access Research Institute
Brooksville, Florida, United States, 34613
Actively Recruiting
17
Gastro Florida
Clearwater, Florida, United States, 33762
Actively Recruiting
18
Doral Medical Research, LLC
Hialeah, Florida, United States, 33016
Withdrawn
19
Digestive and Liver Center of Florida, P.A.
Kissimmee, Florida, United States, 34741
Actively Recruiting
20
Gastro Health Research - Miami
Miami, Florida, United States, 33176
Actively Recruiting
21
The Clinical Trials Network CTNX LLC
Orange City, Florida, United States, 32763
Actively Recruiting
22
Endoscopic Research, Inc.
Orlando, Florida, United States, 32803
Actively Recruiting
23
Orlando Health-Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Actively Recruiting
24
Digestive and Liver Center of Florida
Orlando, Florida, United States, 32825
Withdrawn
25
Gastro Health Research - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
26
West Central Gastroenterology d/b/a Gastro Florida
Pinellas Park, Florida, United States, 33781
Actively Recruiting
27
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30327
Actively Recruiting
28
AGA GA Research LLC
Atlanta, Georgia, United States, 30342
Actively Recruiting
29
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States, 30033
Withdrawn
30
Yapp, Rockford M.D. (Private Practice)
Downers Grove, Illinois, United States, 60515
Actively Recruiting
31
GI Alliance - Glenview
Glenview, Illinois, United States, 60026
Actively Recruiting
32
Gastroenterology and Internal Medicine Specialists, SC
Lake Barrington, Illinois, United States, 60010
Actively Recruiting
33
Suburban Gastroenterology
Naperville, Illinois, United States, 60540
Withdrawn
34
GI Partners of Illinois - Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
35
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States, 61107
Actively Recruiting
36
Springfield Clinic
Springfield, Illinois, United States, 62703
Actively Recruiting
37
Hutchinson Clinic
Hutchinson, Kansas, United States, 67502
Actively Recruiting
38
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, United States, 41017
Active, Not Recruiting
39
Baton Rouge General Medical Center - Bluebonnet Campus
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
40
Combined Gastro LLC
Lafayette, Louisiana, United States, 70503
Active, Not Recruiting
41
GI Alliance
Metairie, Louisiana, United States, 70006
Actively Recruiting
42
Portland Gastroenterology Center
Portland, Maine, United States, 04101
Actively Recruiting
43
Capital Digestive Care
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
44
Woodholme Gastroenterology
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
45
Gastro Health Research - Framingham
Framingham, Massachusetts, United States, 01702
Actively Recruiting
46
Lucida Clinical Trials LLC
New Bedford, Massachusetts, United States, 02740
Actively Recruiting
47
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States, 49519
Actively Recruiting
48
Huron Gastro
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
49
MNGI Digestive Health, P.A.
Plymouth, Minnesota, United States, 55446
Withdrawn
50
Delta Gastroenterology and Endoscopy Center
Southaven, Mississippi, United States, 38671
Actively Recruiting
51
GI Associates Research, LLC
Columbia, Missouri, United States, 65201
Actively Recruiting
52
Mid America Gastro Intestinal Consultants
Kansas City, Missouri, United States, 64111
Actively Recruiting
53
St Charles Clinical Research
Weldon Spring, Missouri, United States, 63304
Actively Recruiting
54
Advanced Research Institute
Reno, Nevada, United States, 89511
Withdrawn
55
Presbyterian Health care services
Albuquerque, New Mexico, United States, 87107
Withdrawn
56
Westchester Putnam Gastroenterology PC
Carmel, New York, United States, 10512
Actively Recruiting
57
Five Towns Gastroenterology
Cedarhurst, New York, United States, 11516
Active, Not Recruiting
58
IMIDeology
Elmhurst, New York, United States, 11373
Actively Recruiting
59
Intercity Gastroenterology
Fresh Meadows, New York, United States, 11040
Active, Not Recruiting
60
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, United States, 11042
Withdrawn
61
Lenox Hill Hospital
New York, New York, United States, 10075
Withdrawn
62
New York Gastroenterology Associates
New York, New York, United States, 10075
Actively Recruiting
63
Manhattan Clinical Research, LLC
New York, New York, United States, 10279
Withdrawn
64
Gastroenterology Group of Rochester
Rochester, New York, United States, 14620
Withdrawn
65
ProHealth (Seaford) (Optum)
Seaford, New York, United States, 11783
Actively Recruiting
66
Syracuse VA Medical Center
Syracuse, New York, United States, 13210
Withdrawn
67
Digestive Disease Medicine
Utica, New York, United States, 13502
Actively Recruiting
68
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States, 28207
Actively Recruiting
69
Pinehurst Medical Clinic Inc
Pinehurst, North Carolina, United States, 28374
Withdrawn
70
Piedmont Healthcare
Statesville, North Carolina, United States, 28625
Actively Recruiting
71
Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States, 28403
Actively Recruiting
72
Gastro Health Research - Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
73
DSI Research Northridge LLC
Dayton, Ohio, United States, 45414
Actively Recruiting
74
Gastro Health Research - Liberty Township
Liberty Township, Ohio, United States, 45044
Actively Recruiting
75
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
Actively Recruiting
76
DSI Research LLC
Springboro, Ohio, United States, 45066
Actively Recruiting
77
NorthShore Gastroenterology Research, LLC
Westlake, Ohio, United States, 44145
Actively Recruiting
78
The Oregon Clinic, P.C.
Portland, Oregon, United States, 97220
Actively Recruiting
79
University Gastroenterology
Providence, Rhode Island, United States, 02904
Actively Recruiting
80
Palmetto Primary Care Physician Division of Gastroenterology
Summerville, South Carolina, United States, 29486
Actively Recruiting
81
Sanford Center for Digestive Health
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
82
Tri-Cities Gastroenterology
Kingsport, Tennessee, United States, 37663
Actively Recruiting
83
The Clinical Trials Network CTNX LLC
El Paso, Texas, United States, 79936
Actively Recruiting
84
Amel Med LLC
Georgetown, Texas, United States, 78628
Actively Recruiting
85
Kelsey Research Foundation
Houston, Texas, United States, 77005
Actively Recruiting
86
MedCare Pharma LLC
Houston, Texas, United States, 77079
Active, Not Recruiting
87
Integrity Advanced Therapeutics
Houston, Texas, United States, 77090
Withdrawn
88
Spring Clinical Research
Houston, Texas, United States, 77090
Active, Not Recruiting
89
One of a Kind Clinical Research Center LLC
Kingwood, Texas, United States, 77339
Actively Recruiting
90
West Texas Research Institute
Lubbock, Texas, United States, 79424
Actively Recruiting
91
Texas Gastro Consultants
Tomball, Texas, United States, 77375
Withdrawn
92
Digestive Research of Central Texas, LLC
Waco, Texas, United States, 76712
Actively Recruiting
93
GI Alliance - Webster
Webster, Texas, United States, 77598
Actively Recruiting
94
Advanced Research Institute
Ogden, Utah, United States, 84405
Withdrawn
95
Gastroenterology Consultants of Southwest Virginia.
Roanoke, Virginia, United States, 24014
Actively Recruiting
96
Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research
Suffolk, Virginia, United States, 23435
Withdrawn
97
TMPG Clinical Research
Williamsburg, Virginia, United States, 23188
Withdrawn
98
GI Alliance
Bellevue, Washington, United States, 98405
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
2
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