RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-12
Study Completion:2027-07-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06095128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
  2. 2. Has moderately to severely active UC as determined by a complete Mayo score \[including physician's global assessment (PGA)\] of 6 to 12 with a rectal bleeding subscore ≥\>1 and a centrally assessed endoscopic subscore ≥2 at screening.
  3. 3. Has evidence of UC extending proximally to the rectum \[≥15 centimeter (cm) of involved colon\].
  4. 4. Participants with extensive colitis or pancolitis of \>8 years duration or left sided colitis \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
  5. 5. Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factors must be up to date on colorectal cancer surveillance.
  6. 6. Has demonstrated an inadequate response to, loss of response to, or intolerance to no more than 2 TNF antagonists.
  7. 7. If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 20 milligrams per day (mg/day) of prednisone or equivalent for at least 4 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids from enrollment.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

Digestive Health Specialsits
Dothan, Alabama, 36301
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Hoag Hospital Newport Beach
Newport Beach, California, 92663
United States
Endoscopic Research Inc
Orlando, Florida, 32803
United States
Alliance Clinical Research of Tampa, LLC
Tampa, Florida, 33615
United States
Gastroenterology Consultants, P.C.
Roswell, Georgia, 30076
United States
University of Chicago Medicine
Chicago, Illinois, 60637
United States
GI Alliance - Illinois Gastroenterology Group - Glenview
Glenview, Illinois, 60026
United States
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Gurnee, Illinois, 60031
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Louisville
Louisville, Kentucky, 40202
United States
GI Alliance
Metairie, Louisiana, 70006
United States
Capital Digestive Care - MGG Group - Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, 48038
United States
Huron Gastroenterology Associates, P.C.
Ypsilanti, Michigan, 48197
United States
MNGI Digestive Health, PA
Plymouth, Minnesota, 55446
United States
Mid-America Gastro-Intestinal Consultants
Kansas City, Missouri, 64111
United States
BVL Clinical Research
Liberty, Missouri, 64068
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Inflammatory Bowel Disease Center at NYU Langone
New York, New York, 10016
United States
Weill Cornell Medical College- New York Presbyterian Hospital
New York, New York, 10065
United States
Digestive Health Partners - Asheville Gastroenterology Associate
Asheville, North Carolina, 28801
United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7080
United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
United States
University of Cincinnati
Cincinnati, Ohio, 45627
United States
Ohio Gastroenterology group, Inc.
Columbus, Ohio, 43202
United States
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Westlake, Ohio, 44145
United States
Hightower Clinical - SSM Health
Oklahoma City, Oklahoma, 73102
United States
Allegheny Health Network
Wexford, Pennsylvania, 15090
United States
University Gastroenterology
Providence, Rhode Island, 02905
United States
Rapid City Medical Center, LLP
Rapid City, South Dakota, 57701
United States
GI Alliance - Digestive Health Associates of Texas
Dallas, Texas, 75044
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
GI Alliance - Mansfield
Mansfield, Texas, 76063
United States
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas, 78229
United States
Texas Digestive Disease Consultants (TDDC), Southlake
Southlake, Texas, 76092
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
GI Alliance - Webster
Webster, Texas, 77598
United States
University of Utah Health
Salt Lake City, Utah, 84108
United States
Washington Gastroenterology- GIA
Bellevue, Washington, 98004
United States
Washington Gastroenterology- GIA
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-12
Study Completion Date2027-07-09

Study Record Updates

Study Start Date2024-06-12
Study Completion Date2027-07-09

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy

Additional Relevant MeSH Terms

  • Ulcerative Colitis