A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC) (NCT06095128)
An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Digestive Health Specialsits — Dothan, Alabama
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (46 Sites)
Showing the first 25 of 46 sites.
- Digestive Health Specialsits — Dothan, Alabama
- GI Alliance Sun City — Sun City, Arizona
- Cedars-Sinai Medical Center — Los Angeles, California
- Hoag Hospital Newport Beach — Newport Beach, California
- Endoscopic Research Inc — Orlando, Florida
- Alliance Clinical Research of Tampa, LLC — Tampa, Florida
- Gastroenterology Consultants, P.C. — Roswell, Georgia
- University of Chicago Medicine — Chicago, Illinois
- University of Kansas Medical Center — Kansas City, Kansas
- University of Louisville — Louisville, Kentucky
- GI Alliance — Metairie, Louisiana
- Tulane University — New Orleans, Louisiana
- Capital Digestive Care - MGG Group - Chevy Chase Clinical Research — Chevy Chase, Maryland
- Huron Gastroenterology Associates, P.C. — Ypsilanti, Michigan
- MNGI Digestive Health, PA — Plymouth, Minnesota
- Mid-America Gastro-Intestinal Consultants — Kansas City, Missouri
- BVL Clinical Research — Liberty, Missouri
- Washington University School of Medicine — St Louis, Missouri
- NYU Langone Health — New York, New York
- Weill Cornell Medical College- New York Presbyterian Hospital — New York, New York
- Digestive Health Partners — Asheville, North Carolina
- University of North Carolina — Chapel Hill, North Carolina
- University of Cincinnati — Cincinnati, Ohio
- Ohio Gastroenterology group, Inc. — Columbus, Ohio
- Gastro Intestinal Research Institute of Northern Ohio, LLC. — Westlake, Ohio
📞 Contact the Study Coordinator
Phone: (877) 825-3327
Email: medinfoUS@takeda.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis
- A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) — Dothan, Alabama
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis — San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis — Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis — Los Angeles, California
- Angiographic Delivery of AD-MSC for Ulcerative Colitis — Rochester, Minnesota
Explore by condition: All Ulcerative Colitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.