RecruitingPhase 4NCT06095128

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

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

Sponsor

Takeda

Enrollment

65 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

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. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two treatments — vedolizumab (an infusion that targets gut inflammation) and tofacitinib (an oral pill that blocks inflammation pathways) — works better than either drug alone in adults with moderate to severe ulcerative colitis (UC), a chronic inflammatory bowel disease. **You may be eligible if...** - You have had a confirmed UC diagnosis for at least 3 months, backed by both endoscopy and biopsy - Your UC is moderately to severely active (confirmed by colonoscopy score) - The affected area of your colon extends at least 15 cm from the rectum upward - You have had adequate surveillance colonoscopies if you have had UC for many years **You may NOT be eligible if...** - You have had a colostomy, ileostomy, or bowel surgery for UC - You have active or recent serious infections - You are pregnant or breastfeeding - You have a blood clot history or significant cardiovascular disease - You have had prior treatment with certain biologics that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVedolizumab

Vedolizumab IV infusions

DRUGTofacitinib

Tofacitinib Tablets

Locations(49)

Digestive Health Specialsits

Dothan, Alabama, United States

GI Alliance Sun City

Sun City, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Hoag Hospital Newport Beach

Newport Beach, California, United States

Endoscopic Research Inc

Orlando, Florida, United States

Alliance Clinical Research of Tampa, LLC

Tampa, Florida, United States

Gastroenterology Consultants, P.C.

Roswell, Georgia, United States

University of Chicago Medicine

Chicago, Illinois, United States

GI Alliance - Illinois Gastroenterology Group - Glenview

Glenview, Illinois, United States

GI Alliance - Illinois Gastroenterology Group LLC - Gurnee

Gurnee, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

GI Alliance

Metairie, Louisiana, United States

Tulane University

New Orleans, Louisiana, United States

Capital Digestive Care - MGG Group - Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Huron Gastroenterology Associates, P.C.

Ypsilanti, Michigan, United States

MNGI Digestive Health, PA

Plymouth, Minnesota, United States

Mid-America Gastro-Intestinal Consultants

Kansas City, Missouri, United States

BVL Clinical Research

Liberty, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

Weill Cornell Medical College- New York Presbyterian Hospital

New York, New York, United States

Digestive Health Partners

Asheville, North Carolina, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio Gastroenterology group, Inc.

Columbus, Ohio, United States

Gastro Intestinal Research Institute of Northern Ohio, LLC.

Westlake, Ohio, United States

Allegheny Health Network

Wexford, Pennsylvania, United States

University Gastroenterology

Providence, Rhode Island, United States

Rapid City Medical Center, LLP

Rapid City, South Dakota, United States

GI Alliance - Digestive Health Associates of Texas

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

GI Alliance - Mansfield

Mansfield, Texas, United States

Gastroenterology Research of San Antonio, LLC

San Antonio, Texas, United States

Texas Digestive Disease Consultants (TDDC), Southlake

Southlake, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

GI Alliance - Webster

Webster, Texas, United States

University of Utah Health

Salt Lake City, Utah, United States

Washington Gastroenterology- GIA

Bellevue, Washington, United States

Washington Gastroenterology- GIA

Tacoma, Washington, United States

Barrie GI Associates Inc.

Barrie, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

West GTA Endoscopy Inc.

Mississauga, Ontario, Canada

Viable Clinical Research - North Bay

North Bay, Ontario, Canada

Toronto Immune and Digestive Health Institute Inc. (TIDHI)

North York, Ontario, Canada

ABP Research Services Corp.

Oakville, Ontario, Canada

Taunton Surgical Centre

Oshawa, Ontario, Canada

Toronto Digestive Disease Associates (TDDA) Inc.

Vaughan, Ontario, Canada

The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06095128

Related Trials

A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice

NCT0696411319 locations

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT0544256798 locations

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

NCT0718500920 locations

Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population

NCT071772091 location

Predictors of Prognosis in IBD Patients

NCT056530111 location