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Double drug attack on ulcerative colitis shows promise

NCT ID NCT06095128

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 21, 2026 · Updated 6 times

Summary

This study tests whether combining two drugs—vedolizumab and tofacitinib—can quickly bring moderate to severe ulcerative colitis under control. About 65 adults will receive both drugs for 8 weeks, and those who respond will continue on vedolizumab alone for nearly a year. The goal is to see if this approach leads to remission and long-term symptom control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vedolizumab and tofacitinib
What this could lead to
If successful, this could offer a new dual-drug strategy to quickly control ulcerative colitis and then maintain remission with a single drug.
What could go wrong
This is a small, early-phase study with only 65 participants and no placebo group, so results may not apply broadly. Combining two immune-suppressing drugs also raises infection risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Has moderately to severely active UC as determined by a complete Mayo score \[including PGA\] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening. 3. Has evidence of UC extending proximally to the rectum \[≥15 centimeter (cm) of involved colon\]. 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. 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. Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFα antagonists. Determination of inadequate response, loss of response, or intolerance is based upon investigator's clinical judgment. 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 per standard of care treatment without prior exposure to biologics may be enrolled if deemed appropriate. Determination of inadequate response, loss of response, or intolerance is based upon investigator's clinical judgment. 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. Exclusion Criteria: Gastrointestinal Exclusion criteria: 1. Has any of the following UC-related complications: 1. Acute severe UC. 2. The participant has had extensive colonic resection, subtotal or total colectomy. 3. The participant has clinical evidence of abdominal abscess or toxic megacolon. 4. The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 5. Short bowel syndrome. 2. 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. 3. Has uncontrolled primary sclerosing cholangitis. Infectious Disease Exclusion Criteria: 1. Has any evidence of an active systemic infection during screening. Participants with nonsystemic infections (eg, active fungal infection of nail beds) may be eligible, if in the opinion of the investigator, inclusion of the participant will not interfere with the collection or interpretation of study results and poses no risk to the participant. 2. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following: 1. History of TB. 2. 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 participants receiving the equivalent of \>15 mg daily prednisone). 3. A positive test for hepatitis B virus (HBV). 4. A positive test for hepatitis C virus (HCV). 5. Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen during screening. 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. 6. Evidence of active Cytomegalovirus (CMV) infection at screening. Medication exclusion criteria: 1. Has received immunomodulators (eg, 6-mercaptopurine, azathioprine, and methotrexate) within 4 weeks prior to first dose or immunosuppressants (eg, cyclosporine, tacrolimus) within 8 weeks prior to first dose. 2. Any medicinal product, herbal medication, or natural health product which might interfere with cytochrome P450 genotype 3A4 (CYP3A4) within 2 weeks prior to enrollment, except for any CYP3A4 modulator used to treat a C. difficile or an intestinal pathogen infection at screening. 3. Has received any of the following medical therapies for UC: 1. IV antibiotics within 8 weeks prior to enrollment. 2. Any rectal therapy for treatment of UC within 2 weeks prior to screening endoscopy. 3. Chronic NSAID use defined as daily use for \>2 consecutive weeks (Note: occasional use \[\<2 consecutive weeks\] of NSAIDs and acetaminophen \[\<100 mg daily\] for headache, arthritis, myalgias, or menstrual cramps and chronic low dose aspirin use \[81-162.5 mg daily\] for cardiovascular prophylaxis are permitted). 4. Has received a live vaccine within 4 weeks prior to first dose. General Exclusion Criteria: 1. Has any of the following cardiovascular or thrombotic conditions: 1. Recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting. 2. Recent (within past 6 months) moderate to severe congestive heart failure (New York Heart Association class III or IV). 3. Prior history of thrombotic events, including deep vein thrombosis and pulmonary embolism. 4. Known inherited conditions that predispose to hypercoagulability. 2. History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly. 3. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to undergo major surgery during the study period. 4. Any investigational procedure ≤4 weeks prior to screening that, in the investigator's opinion, may interfere with interpretation of study results.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    46 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ABP Research Services Corp.

    RECRUITING

    Oakville, Ontario, L6L 5L7, Canada

  • Allegheny Health Network

    RECRUITING

    Wexford, Pennsylvania, 15090, United States

  • Alliance Clinical Research of Tampa, LLC

    RECRUITING

    Tampa, Florida, 33615, United States

  • BVL Clinical Research

    RECRUITING

    Liberty, Missouri, 64068, United States

  • Barrie GI Associates Inc.

    RECRUITING

    Barrie, Ontario, L4M 7G1, Canada

  • Capital Digestive Care - MGG Group - Chevy Chase Clinical Research

    RECRUITING

    Chevy Chase, Maryland, 20815, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Digestive Health Partners

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • Digestive Health Specialsits

    RECRUITING

    Dothan, Alabama, 36301, United States

  • Endoscopic Research Inc

    RECRUITING

    Orlando, Florida, 32803, United States

  • GI Alliance

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • GI Alliance - Digestive Health Associates of Texas

    RECRUITING

    Dallas, Texas, 75044, United States

  • GI Alliance - Mansfield

    RECRUITING

    Mansfield, Texas, 76063, United States

  • GI Alliance - Webster

    RECRUITING

    Webster, Texas, 77598, United States

  • GI Alliance Sun City

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Gastro Intestinal Research Institute of Northern Ohio, LLC.

    RECRUITING

    Westlake, Ohio, 44145, United States

  • Gastroenterology Consultants, P.C.

    RECRUITING

    Roswell, Georgia, 30076, United States

  • Gastroenterology Research of San Antonio, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Hoag Hospital Newport Beach

    RECRUITING

    Newport Beach, California, 92663, United States

  • Huron Gastroenterology Associates, P.C.

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • MNGI Digestive Health, PA

    RECRUITING

    Plymouth, Minnesota, 55446, United States

  • Mid-America Gastro-Intestinal Consultants

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Ohio Gastroenterology group, Inc.

    RECRUITING

    Columbus, Ohio, 43202, United States

    Contact Email: •••••@•••••

  • Sanford Health Research

    RECRUITING

    Rapid City, South Dakota, 57701, United States

  • Taunton Surgical Centre

    RECRUITING

    Oshawa, Ontario, L1J 0C7, Canada

  • Texas Digestive Disease Consultants (TDDC), Southlake

    RECRUITING

    Southlake, Texas, 76092, United States

  • The Research Institute of the McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Toronto Digestive Disease Associates (TDDA) Inc.

    RECRUITING

    Vaughan, Ontario, L4L 4Y7, Canada

  • Toronto Immune and Digestive Health Institute Inc. (TIDHI)

    RECRUITING

    North York, Ontario, M6A3B4, Canada

  • Tulane University

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Tyler Research Institute, LLC

    RECRUITING

    Tyler, Texas, 75701, United States

  • University Gastroenterology

    RECRUITING

    Providence, Rhode Island, 02094, United States

  • University of Chicago Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45627, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Viable Clinical Research - North Bay

    RECRUITING

    North Bay, Ontario, P1B 2H3, Canada

  • Washington Gastroenterology- GIA

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College- New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10065, United States

  • West GTA Endoscopy Inc.

    RECRUITING

    Mississauga, Ontario, L5M 7N4, Canada

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