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

Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

• 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.

• Has evidence of UC extending proximally to the rectum \[≥15 centimeter (cm) of involved colon\].

• 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.

• 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.

• Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFα antagonists. Participants without prior failure or intolerance to biologics are not eligible. Participants who discontinued TNFα antagonist therapy for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the medical monitor.

• Note: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate. Participants who discontinued biologics for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the Medical Monitor.

• If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 40 mg daily of prednisone or 9 mg daily of budesonide, or equivalent for at least 2 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids from enrollment.

Locations
United States
Alabama
Digestive Health Specialsits
RECRUITING
Dothan
Arizona
GI Alliance Sun City
RECRUITING
Sun City
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Hoag Hospital Newport Beach
RECRUITING
Newport Beach
Florida
Endoscopic Research Inc
RECRUITING
Orlando
Alliance Clinical Research of Tampa, LLC
RECRUITING
Tampa
Georgia
Gastroenterology Consultants, P.C.
RECRUITING
Roswell
Illinois
University of Chicago Medicine
RECRUITING
Chicago
GI Alliance - Illinois Gastroenterology Group - Glenview
RECRUITING
Glenview
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
RECRUITING
Gurnee
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
University of Louisville
RECRUITING
Louisville
Louisiana
GI Alliance
RECRUITING
Metairie
Tulane University
NOT_YET_RECRUITING
New Orleans
Maryland
Capital Digestive Care - MGG Group - Chevy Chase Clinical Research
RECRUITING
Chevy Chase
Michigan
Huron Gastroenterology Associates, P.C.
RECRUITING
Ypsilanti
Minnesota
MNGI Digestive Health, PA
RECRUITING
Plymouth
Missouri
Mid-America Gastro-Intestinal Consultants
RECRUITING
Kansas City
BVL Clinical Research
RECRUITING
Liberty
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Digestive Health Partners - Asheville Gastroenterology Associate
RECRUITING
Asheville
University of North Carolina
RECRUITING
Chapel Hill
New York
NYU Langone Health
RECRUITING
New York
Weill Cornell Medical College- New York Presbyterian Hospital
RECRUITING
New York
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Ohio Gastroenterology group, Inc.
RECRUITING
Columbus
Gastro Intestinal Research Institute of Northern Ohio, LLC.
RECRUITING
Westlake
Pennsylvania
Thomas Jefferson University Hospital
NOT_YET_RECRUITING
Philadelphia
Allegheny Health Network
RECRUITING
Wexford
Rhode Island
University Gastroenterology
RECRUITING
Providence
South Dakota
Rapid City Medical Center, LLP
RECRUITING
Rapid City
Texas
GI Alliance - Digestive Health Associates of Texas
RECRUITING
Dallas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
GI Alliance - Mansfield
RECRUITING
Mansfield
Gastroenterology Research of San Antonio, LLC
RECRUITING
San Antonio
Texas Digestive Disease Consultants (TDDC), Southlake
RECRUITING
Southlake
Tyler Research Institute, LLC
RECRUITING
Tyler
GI Alliance - Webster
RECRUITING
Webster
Utah
University of Utah Health
RECRUITING
Salt Lake City
Washington
Washington Gastroenterology- GIA
WITHDRAWN
Bellevue
Washington Gastroenterology- GIA
RECRUITING
Tacoma
Other Locations
Canada
Barrie GI Associates Inc.
RECRUITING
Barrie
London Health Sciences Centre
RECRUITING
London
West GTA Endoscopy Inc.
RECRUITING
Mississauga
McGill University Health Centre Montreal General Hospital
NOT_YET_RECRUITING
Montreal
Viable Clinical Research - North Bay
RECRUITING
North Bay
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
RECRUITING
North York
ABP Research Services Corp.
RECRUITING
Oakville
Taunton Surgical Centre
RECRUITING
Oshawa
Toronto Digestive Disease Associates (TDDA) Specialty Research
RECRUITING
Vaughan
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2027-07-09
Participants
Target number of participants: 65
Treatments
Experimental: Vedolizumab 300 mg + Tofacitinib 10 mg
Participants will receive Vedolizumab 300 mg, intravenous (IV) infusion, at Week 0, Week 2 and Week 6 along with Tofacitinib 10 mg, tablets, orally, twice daily from Week 0 to Week 8. Participants with clinical response at Week 8 will transition to receive vedolizumab 300 mg IV infusion every 8 weeks (Q8W) through Week 46.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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