Actively Recruiting
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Led by Takeda · Updated on 2026-03-18
65
Participants Needed
49
Research Sites
160 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 tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.
CONDITIONS
Official Title
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of ulcerative colitis for at least 3 months by clinical, endoscopic, and histopathology evidence
- Moderately to severely active ulcerative colitis with a complete Mayo score of 6 to 12, rectal bleeding subscore 61, and endoscopic subscore 62 at screening
- Ulcerative colitis involving at least 15 centimeters of colon
- For extensive colitis or pancolitis over 8 years, or left sided colitis over 12 years, recent surveillance colonoscopy within 12 months prior to screening
- Up to date colorectal cancer surveillance if age over 50 or with other colorectal cancer risk factors
- Inadequate response, loss of response, or intolerance to 1 or 2 TNFb1 antagonists; no prior biologic failure or intolerance not eligible except with medical monitor approval
- If using corticosteroids, stable dose up to 40 mg prednisone or 9 mg budesonide daily for at least 2 weeks prior to screening and willingness to taper corticosteroids
You will not qualify if you...
- Acute severe ulcerative colitis or history of extensive colonic resection
- Presence of abdominal abscess, toxic megacolon, ileostomy, colostomy, or fixed symptomatic intestinal stenosis
- Short bowel syndrome
- Other colitis types such as Crohn's colitis, indeterminate colitis, ischemic colitis, NSAID-induced colitis, idiopathic colitis, radiation colitis, microscopic colitis, or colonic mucosal dysplasia
- Uncontrolled primary sclerosing cholangitis
- Active systemic infections or evidence of tuberculosis, hepatitis B or C, Clostridium difficile infection within 28 days, or active cytomegalovirus infection
- Recent use of immunomodulators or immunosuppressants, interfering medications, IV antibiotics, rectal therapy, or chronic NSAID use
- Recent live virus or bacterial vaccine within 4 weeks or planned vaccination during study and 12 weeks after
- Recent serious cardiovascular events, thrombotic history, inherited hypercoagulability, lymphoproliferative disease, recent major surgery, or recent investigational procedures that may interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 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
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
Hoag Hospital Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
5
Endoscopic Research Inc
Orlando, Florida, United States, 32803
Actively Recruiting
6
Alliance Clinical Research of Tampa, LLC
Tampa, Florida, United States, 33615
Actively Recruiting
7
Gastroenterology Consultants, P.C.
Roswell, Georgia, United States, 30076
Actively Recruiting
8
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
9
GI Alliance - Illinois Gastroenterology Group - Glenview
Glenview, Illinois, United States, 60026
Actively Recruiting
10
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Gurnee, Illinois, United States, 60031
Actively Recruiting
11
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
12
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
13
GI Alliance
Metairie, Louisiana, United States, 70006
Actively Recruiting
14
Tulane University
New Orleans, Louisiana, United States, 70112
Actively Recruiting
15
Capital Digestive Care - MGG Group - Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
16
Huron Gastroenterology Associates, P.C.
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
17
MNGI Digestive Health, PA
Plymouth, Minnesota, United States, 55446
Actively Recruiting
18
Mid-America Gastro-Intestinal Consultants
Kansas City, Missouri, United States, 64111
Actively Recruiting
19
BVL Clinical Research
Liberty, Missouri, United States, 64068
Actively Recruiting
20
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
21
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
22
Weill Cornell Medical College- New York Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
23
Digestive Health Partners
Asheville, North Carolina, United States, 28801
Actively Recruiting
24
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
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
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Westlake, Ohio, United States, 44145
Actively Recruiting
28
Allegheny Health Network
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
29
University Gastroenterology
Providence, Rhode Island, United States, 02905
Actively Recruiting
30
Rapid City Medical Center, LLP
Rapid City, South Dakota, United States, 57701
Actively Recruiting
31
GI Alliance - Digestive Health Associates of Texas
Dallas, Texas, United States, 75044
Actively Recruiting
32
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
33
GI Alliance - Mansfield
Mansfield, Texas, United States, 76063
Actively Recruiting
34
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
35
Texas Digestive Disease Consultants (TDDC), Southlake
Southlake, Texas, United States, 76092
Actively Recruiting
36
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
Actively Recruiting
37
GI Alliance - Webster
Webster, Texas, United States, 77598
Actively Recruiting
38
University of Utah Health
Salt Lake City, Utah, United States, 84108
Actively Recruiting
39
Washington Gastroenterology- GIA
Bellevue, Washington, United States, 98004
Withdrawn
40
Washington Gastroenterology- GIA
Tacoma, Washington, United States, 98405
Actively Recruiting
41
Barrie GI Associates Inc.
Barrie, Ontario, Canada, L4M 7G1
Actively Recruiting
42
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Actively Recruiting
43
West GTA Endoscopy Inc.
Mississauga, Ontario, Canada, L5M 7N4
Actively Recruiting
44
Viable Clinical Research - North Bay
North Bay, Ontario, Canada, P1B 2H3
Actively Recruiting
45
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
North York, Ontario, Canada, M6A3B4
Actively Recruiting
46
ABP Research Services Corp.
Oakville, Ontario, Canada, L6L 5L7
Actively Recruiting
47
Taunton Surgical Centre
Oshawa, Ontario, Canada, L1J 0C7
Actively Recruiting
48
Toronto Digestive Disease Associates (TDDA) Inc.
Vaughan, Ontario, Canada, L4L 4Y7
Actively Recruiting
49
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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