A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
NCT06095128
This study is recruiting at 37 US sites in 22 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Ulcerative Colitis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 4
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Takeda
- Last updated on ClinicalTrials.gov
- September 21, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- Digestive Health Specialsits · Dothan, AL
Arizona · 1
- GI Alliance Sun City · Sun City, AZ
California · 2
- Cedars-Sinai Medical Center · Los Angeles, CA
- Hoag Hospital Newport Beach · Newport Beach, CA
Florida · 2
- Endoscopic Research Inc · Orlando, FL
- Alliance Clinical Research of Tampa, LLC · Tampa, FL
Georgia · 1
- Gastroenterology Consultants, P.C. · Roswell, GA
Illinois · 1
- University of Chicago Medicine · Chicago, IL
Kansas · 1
- University of Kansas Medical Center · Kansas City, KS
Kentucky · 1
- University of Louisville · Louisville, KY
Louisiana · 2
- GI Alliance · Metairie, LA
- Tulane University · New Orleans, LA
Maryland · 1
- Capital Digestive Care - MGG Group - Chevy Chase Clinical Research · Chevy Chase, MD
Michigan · 1
- Huron Gastroenterology Associates, P.C. · Ypsilanti, MI
Minnesota · 1
- MNGI Digestive Health, PA · Plymouth, MN
Missouri · 3
- Mid-America Gastro-Intestinal Consultants · Kansas City, MO
- BVL Clinical Research · Liberty, MO
- Washington University School of Medicine · St Louis, MO
New York · 2
- NYU Langone Health · New York, NY
- Weill Cornell Medical College- New York Presbyterian Hospital · New York, NY
North Carolina · 2
- Digestive Health Partners · Asheville, NC
- University of North Carolina · Chapel Hill, NC
Ohio · 3
- University of Cincinnati · Cincinnati, OH
- Ohio Gastroenterology group, Inc. · Columbus, OH
- Gastro Intestinal Research Institute of Northern Ohio, LLC. · Westlake, OH
Pennsylvania · 1
- Allegheny Health Network · Wexford, PA
Rhode Island · 1
- University Gastroenterology · Providence, RI
South Dakota · 1
- Sanford Health Research · Rapid City, SD
Texas · 7
- GI Alliance - Digestive Health Associates of Texas · Dallas, TX
- The University of Texas Health Science Center at Houston · Houston, TX
- GI Alliance - Mansfield · Mansfield, TX
- Gastroenterology Research of San Antonio, LLC · San Antonio, TX
- Texas Digestive Disease Consultants (TDDC), Southlake · Southlake, TX
- Tyler Research Institute, LLC · Tyler, TX
- GI Alliance - Webster · Webster, TX
Utah · 1
- University of Utah Health · Salt Lake City, UT
Washington · 1
- Washington Gastroenterology- GIA · Tacoma, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.