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

NCT06095128 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Vedolizumab-4054
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 49

Brief 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.

Conditions

Ulcerative Colitis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score

  Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore \>1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.

  At Week 8

Secondary Outcomes (20)

• Percentage of Participants Achieving Clinical Remission at Week 52 Based on Complete Mayo Score

  At Week 52

• Percentage of Participants Achieving Clinical Remission at Weeks 8, 14, and 26 Based on Partial Mayo Score

  At Weeks 8, 14 and 26

• Percentage of Participants Achieving Clinical Response at Weeks 2, 6, 8, 14, 26 and 52 Based on Complete or Partial Mayo Score

  At Weeks 2, 6, 8, 14, 26, and 52

• Percentage of Participants Achieving Clinical Remission at Week 8 and Week 52 Based on Modified Mayo Score

  At Weeks 8 and 52

• Percentage of Participants With Durable Clinical Remission at Week 8 and Week 52

  At Week 8 and Week 52

Study Arms (1)

Vedolizumab 300 mg + Tofacitinib 10 mg

EXPERIMENTAL

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.

Drug: Vedolizumab; Drug: Tofacitinib

Interventions

Vedolizumab DRUG

Vedolizumab IV infusions

Also known as: Entyvio, MLN0002

Vedolizumab 300 mg + Tofacitinib 10 mg

Tofacitinib DRUG

Tofacitinib Tablets

Also known as: Xeljanz, CP-690, CP-550

Vedolizumab 300 mg + Tofacitinib 10 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Has any of the following UC-related complications:
• Acute severe UC.
• The participant has had extensive colonic resection, subtotal or total colectomy.
• The participant has clinical evidence of abdominal abscess or toxic megacolon.
• The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
• Short bowel syndrome.
• Has Crohn's colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID) induced colitis, idiopathic colitis (i.e, colitis not consistent with UC), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption. Participants with a history of colonic mucosal dysplasia are also excluded.
• Has uncontrolled primary sclerosing cholangitis.
• Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
• History of TB.
• A diagnostic TB test performed during screening that is positive, as defined by:
• i. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests or ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in subjects receiving the equivalent of \>15 mg daily prednisone).
• A positive test for hepatitis B virus (HBV).
• A positive test for hepatitis C virus (HCV).
• Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen within 28 days prior to first dose of study treatment. Participants who test positive for C. difficile or other intestinal pathogens at screening and receive treatment may be enrolled or rescreened (if required) following confirmation of infection resolution.

Sponsors & Collaborators

• Takeda: lead

Study Sites (49)

Digestive Health Specialsits

Dothan, Alabama, 36301, United States

RECRUITING

GI Alliance Sun City

Sun City, Arizona, 85351, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Hoag Hospital Newport Beach

Newport Beach, California, 92663, United States

RECRUITING

Endoscopic Research Inc

Orlando, Florida, 32803, United States

RECRUITING

Alliance Clinical Research of Tampa, LLC

Tampa, Florida, 33615, United States

RECRUITING

Gastroenterology Consultants, P.C.

Roswell, Georgia, 30076, United States

RECRUITING

University of Chicago Medicine

Chicago, Illinois, 60637, United States

RECRUITING

GI Alliance - Illinois Gastroenterology Group - Glenview

Glenview, Illinois, 60026, United States

RECRUITING

GI Alliance - Illinois Gastroenterology Group LLC - Gurnee

Gurnee, Illinois, 60031, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

GI Alliance

Metairie, Louisiana, 70006, United States

RECRUITING

Tulane University

New Orleans, Louisiana, 70112, United States

RECRUITING

Capital Digestive Care - MGG Group - Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

RECRUITING

Huron Gastroenterology Associates, P.C.

Ypsilanti, Michigan, 48197, United States

RECRUITING

MNGI Digestive Health, PA

Plymouth, Minnesota, 55446, United States

RECRUITING

Mid-America Gastro-Intestinal Consultants

Kansas City, Missouri, 64111, United States

RECRUITING

BVL Clinical Research

Liberty, Missouri, 64068, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Weill Cornell Medical College- New York Presbyterian Hospital

New York, New York, 10065, United States

RECRUITING

Digestive Health Partners

Asheville, North Carolina, 28801, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45627, United States

RECRUITING

Ohio Gastroenterology group, Inc.

Columbus, Ohio, 43202, United States

RECRUITING

Gastro Intestinal Research Institute of Northern Ohio, LLC.

Westlake, Ohio, 44145, United States

RECRUITING

Allegheny Health Network

Wexford, Pennsylvania, 15090, United States

RECRUITING

University Gastroenterology

Providence, Rhode Island, 02905, United States

RECRUITING

Rapid City Medical Center, LLP

Rapid City, South Dakota, 57701, United States

RECRUITING

GI Alliance - Digestive Health Associates of Texas

Dallas, Texas, 75044, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

GI Alliance - Mansfield

Mansfield, Texas, 76063, United States

RECRUITING

Gastroenterology Research of San Antonio, LLC

San Antonio, Texas, 78229, United States

RECRUITING

Texas Digestive Disease Consultants (TDDC), Southlake

Southlake, Texas, 76092, United States

RECRUITING

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

RECRUITING

GI Alliance - Webster

Webster, Texas, 77598, United States

RECRUITING

University of Utah Health

Salt Lake City, Utah, 84108, United States

RECRUITING

Washington Gastroenterology- GIA

Bellevue, Washington, 98004, United States

WITHDRAWN

Washington Gastroenterology- GIA

Tacoma, Washington, 98405, United States

RECRUITING

Barrie GI Associates Inc.

Barrie, Ontario, L4M 7G1, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

West GTA Endoscopy Inc.

Mississauga, Ontario, L5M 7N4, Canada

RECRUITING

Viable Clinical Research - North Bay

North Bay, Ontario, P1B 2H3, Canada

RECRUITING

Toronto Immune and Digestive Health Institute Inc. (TIDHI)

North York, Ontario, M6A3B4, Canada

RECRUITING

ABP Research Services Corp.

Oakville, Ontario, L6L 5L7, Canada

RECRUITING

Taunton Surgical Centre

Oshawa, Ontario, L1J 0C7, Canada

RECRUITING

Toronto Digestive Disease Associates (TDDA) Inc.

Vaughan, Ontario, L4L 4Y7, Canada

RECRUITING

The Research Institute of the McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab; tofacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 23, 2023
• Study Start: June 12, 2024
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (40); CA (9)