Actively Recruiting
A Phase 4 Study Evaluating Vedolizumab for Moderate to Severely Active Ulcerative Colitis or Crohn's Disease in a Community Setting
Led by Takeda · Updated on 2026-05-29
400
Participants Needed
100
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with moderate to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD), which are long-term gut conditions causing symptoms like diarrhea, inflammation, bleeding, and belly pain. The study aims to evaluate how many participants achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 trial sponsored by Takeda, focused on treatment in a community setting. Participants will receive Vedolizumab initially as an intravenous infusion at weeks 0 and 2. Around week 6, participants may switch to subcutaneous injections every two weeks until week 50. Some participants might receive an additional intravenous dose at week 6 before switching. Those whose treatment does not seem effective by week 14 may stop and switch to other therapies. Additional visits occur at weeks 26 and 52, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit their clinic multiple times for assessments. Researchers will measure remission rates using patient-reported outcomes at various points, including weeks 6, 14, and 52. Other evaluations include clinical responses, endoscopic improvements, and changes in inflammation markers like C-reactive protein and fecal calprotectin. Safety is monitored by tracking infections and adverse events up to 72 weeks, ensuring comprehensive follow-up over approximately one year.
CONDITIONS
Brief 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 prior to study procedures
- Aged 18 to 80 years at consent
- Immunizations up to date per Vedolizumab prescribing information
- Women of childbearing potential must use effective contraception, avoid donating eggs, have a negative pregnancy test before first dose, and avoid breastfeeding during and 18 weeks after treatment
- Fertile men must use contraception and avoid donating sperm during and 18 weeks after treatment
- Diagnosed with moderate to severely active UC or CD confirmed by clinical, endoscopic, and histopathology reports
- Inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, or advanced therapies
You will not qualify if you...
- Prior use of approved or investigational anti-integrin antibodies before screening
- Failed more than two prior advanced treatments
- Use of corticosteroid enemas or suppositories within 2 weeks before screening
- Contraindications or allergies to Vedolizumab or its ingredients
- Use of investigational biologic therapy within 6 months before screening
- Received advanced treatment for conditions other than UC or CD
- Active infection at screening
- Ileostomy, colostomy, severe or symptomatic intestinal stenosis, or short bowel syndrome
- Recent major surgery within 3 months or planned surgery during the study
- History of certain treated skin cancers or cervical carcinoma in situ without recurrence
- History or symptoms of progressive multifocal leukoencephalopathy
- Laboratory abnormalities during screening period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 50 weeks
Participants receive vedolizumab treatment starting with two intravenous infusions at Weeks 0 and 2, followed by subcutaneous injections every 2 weeks from Week 6 until Week 50. An additional intravenous dose may be given at Week 6 with mandatory transition to subcutaneous dosing by Week 14.
Visits every 2 weeks during treatment
Duration - Up to 22 weeks after treatment ends
Participants are monitored for safety and treatment outcomes after completing vedolizumab treatment.
Visits as scheduled until study completion
Trial Site Locations
Total: 100 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
Actively 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
Actively 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
Actively 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
SSM Health Medical Group
Bridgeton, Missouri, United States, 63044
Active, Not Recruiting
52
GI Associates Research, LLC
Columbia, Missouri, United States, 65201
Actively Recruiting
53
Mid America Gastro Intestinal Consultants
Kansas City, Missouri, United States, 64111
Actively Recruiting
54
St Charles Clinical Research
Weldon Spring, Missouri, United States, 63304
Actively Recruiting
55
Advanced Research Institute
Reno, Nevada, United States, 89511
Withdrawn
56
Presbyterian Health care services
Albuquerque, New Mexico, United States, 87107
Withdrawn
57
Westchester Putnam Gastroenterology PC
Carmel, New York, United States, 10512
Actively Recruiting
58
Five Towns Gastroenterology
Cedarhurst, New York, United States, 11516
Active, Not Recruiting
59
IMIDeology
Elmhurst, New York, United States, 11373
Actively Recruiting
60
Intercity Gastroenterology
Fresh Meadows, New York, United States, 11040
Active, Not Recruiting
61
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, United States, 11042
Withdrawn
62
Lenox Hill Hospital
New York, New York, United States, 10075
Withdrawn
63
New York Gastroenterology Associates
New York, New York, United States, 10075
Actively Recruiting
64
Manhattan Clinical Research, LLC
New York, New York, United States, 10279
Withdrawn
65
Gastroenterology Group of Rochester
Rochester, New York, United States, 14620
Withdrawn
66
ProHealth (Seaford) (Optum)
Seaford, New York, United States, 11783
Actively Recruiting
67
Syracuse VA Medical Center
Syracuse, New York, United States, 13210
Withdrawn
68
Digestive Disease Medicine
Utica, New York, United States, 13502
Actively Recruiting
69
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States, 28207
Actively Recruiting
70
Pinehurst Medical Clinic Inc
Pinehurst, North Carolina, United States, 28374
Withdrawn
71
Piedmont Healthcare
Statesville, North Carolina, United States, 28625
Actively Recruiting
72
Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States, 28403
Actively Recruiting
73
Gastro Health Research - Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
74
DSI Research Northridge LLC
Dayton, Ohio, United States, 45414
Actively Recruiting
75
Gastro Health Research - Liberty Township
Liberty Township, Ohio, United States, 45044
Actively Recruiting
76
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
Actively Recruiting
77
DSI Research LLC
Springboro, Ohio, United States, 45066
Actively Recruiting
78
NorthShore Gastroenterology Research, LLC
Westlake, Ohio, United States, 44145
Actively Recruiting
79
The Oregon Clinic, P.C.
Portland, Oregon, United States, 97220
Actively Recruiting
80
University Gastroenterology
Providence, Rhode Island, United States, 02904
Actively Recruiting
81
Palmetto Primary Care Physician Division of Gastroenterology
Summerville, South Carolina, United States, 29486
Actively Recruiting
82
Sanford Center for Digestive Health
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
83
Tri-Cities Gastroenterology
Kingsport, Tennessee, United States, 37663
Actively Recruiting
84
The Clinical Trials Network CTNX LLC
El Paso, Texas, United States, 79936
Actively Recruiting
85
Amel Med LLC
Georgetown, Texas, United States, 78628
Actively Recruiting
86
Kelsey Research Foundation
Houston, Texas, United States, 77005
Actively Recruiting
87
MedCare Pharma LLC
Houston, Texas, United States, 77079
Actively Recruiting
88
Integrity Advanced Therapeutics
Houston, Texas, United States, 77090
Withdrawn
89
Spring Clinical Research
Houston, Texas, United States, 77090
Active, Not Recruiting
90
Gastro Health & Nutrition
Katy, Texas, United States, 77494
Active, Not Recruiting
91
One of a Kind Clinical Research Center LLC
Kingwood, Texas, United States, 77339
Actively Recruiting
92
West Texas Research Institute
Lubbock, Texas, United States, 79424
Actively Recruiting
93
Texas Gastro Consultants
Tomball, Texas, United States, 77375
Withdrawn
94
Digestive Research of Central Texas, LLC
Waco, Texas, United States, 76712
Actively Recruiting
95
GI Alliance - Webster
Webster, Texas, United States, 77598
Actively Recruiting
96
Advanced Research Institute
Ogden, Utah, United States, 84405
Withdrawn
97
Gastroenterology Consultants of Southwest Virginia.
Roanoke, Virginia, United States, 24014
Actively Recruiting
98
Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research
Suffolk, Virginia, United States, 23435
Withdrawn
99
TMPG Clinical Research
Williamsburg, Virginia, United States, 23188
Withdrawn
100
GI Alliance
Bellevue, Washington, United States, 98405
Actively Recruiting
Research Team
T
Takeda 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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