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New study tests switch from IV to At-Home shots for gut disease

NCT ID NCT06581328

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 6 times

Summary

This study is testing the drug vedolizumab (Entyvio) in 400 adults with moderate to severe ulcerative colitis or Crohn's disease. Participants first receive the drug through an IV for 6 weeks, then switch to injections under the skin for the rest of the year. The main goal is to see how many people achieve remission (symptoms disappear) after 14 weeks. The study is being done in community clinics to see how well the treatment works in real-world settings.

What this could mean

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

Active substance
vedolizumab (Entyvio)
What this could lead to
If successful, this study could show that switching from IV to at-home injections of vedolizumab helps people with Crohn's or colitis achieve and maintain remission.
What could go wrong
This is a single-arm, open-label study with no placebo group, so results may be less definitive. Some participants may not respond or may experience side effects like infections or allergic reactions.

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 200 people

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

Started

Mar 2025

Expected to finish

Jun 2028

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 80 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 To be eligible to participate in this study, participants must meet all the following criteria: 1. In the investigator's opinion, the participant can understand and comply with protocol requirements. 2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures. 3. The participant is 18 to 80 years of age at the time of signing the ICF. 4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI). 5. Participants must meet the contraception recommendations. 6. The participant has a diagnosis of moderate to severely active UC or CD defined by the following: 1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening OR 2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy sub-score of 2 to 3 at screening. 7. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report. 8. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy. Exclusion Criteria Participants who meet any of the following exclusion criteria will be excluded from participation in this study: 1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\]) at any time prior to screening. 2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments. 3. Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD). 4. In the investigator's opinion, the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has a medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients. 5. Received any investigational biologic therapy \<= 6 months prior to screening. 6. The participant has received an advanced treatment for an approved indication other than CD or UC within 60 days prior to screening. a. Advanced therapies include tumor necrosis factor (TNF) inhibitors, 12/23 antagonists, janus kinase (JAK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators. 7. The participant has any evidence of an active infection during screening. 8. Ileostomy, colostomy, severe or symptomatic stenosis of the intestine, or short bowel syndrome. 9. A surgical procedure requiring general anesthesia within 30 days prior to screening or planned or possible major surgery during the study period. 10. History of malignancy, except for adequately treated nonmetastatic basal cell skin cancer; adequately treated squamous cell skin cancer that has not recurred for at least 1 year before screening; and adequately treated cervical carcinoma in situ that has not recurred for at least 3 years before screening. Participants with a remote history of malignancy (e.g., \>10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and therapy received; this must be discussed with the sponsor on a case-by-case basis before enrollment. 11. Participants with any unstable or uncontrolled cardiovascular conditions, moderate to severe heart failure (New York Heart Association Class III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorders that, in the investigator's opinion, would confound the study results or compromise participant safety. 12. Participants with active cerebral or meningeal disease, signs or symptoms or a history of progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease. 13. Participant is not on a stable dose of corticosteroid. 14. Has any of the following laboratory abnormalities during the screening period: (a) hemoglobin \<8 grams per deciliter (g/dL); (b) white blood cell (WBC) count \<3.0 × 10\^9 per liter (L); (c) lymphocyte count \<0.5 × 10\^9/L; (d) platelet count \<100 × 10\^9/L or \>1200 × 10\^9/L; (e) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3.0 × the upper limit of normal (ULN); or (f) alkaline phosphatase (ALP) \>1.5 × ULN. Historical laboratory data may be used for screening if available in the participant's electronic health record (EHR) within 6 weeks before screening.

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

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

Crohn's disease 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

    78 sites. 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

  • AGA GA Research LLC

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • AZ Gastro Care

    RECRUITING

    Chandler, Arizona, 85225, United States

  • Access Research Institute

    RECRUITING

    Brooksville, Florida, 34613, United States

  • Advanced Research Institute

    WITHDRAWN

    Reno, Nevada, 89511, United States

  • Advanced Research Institute

    WITHDRAWN

    Ogden, Utah, 84405, United States

  • Amel Med LLC

    RECRUITING

    Georgetown, Texas, 78628, United States

  • Atlanta Center for Gastroenterology, P.C.

    WITHDRAWN

    Decatur, Georgia, 30033, United States

  • Baton Rouge General Medical Center - Bluebonnet Campus

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Capital Digestive Care

    RECRUITING

    Chevy Chase, Maryland, 20815, United States

  • Carolina Digestive Diseases

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research

    WITHDRAWN

    Suffolk, Virginia, 23435, United States

  • Charlotte Gastroenterology and Hepatology, P.L.L.C

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Combined Gastro LLC

    RECRUITING

    Lafayette, Louisiana, 70503, United States

  • Crystal Run (Optum)

    RECRUITING

    West Nyack, New York, 10994, United States

  • DSI Research LLC

    RECRUITING

    Springboro, Ohio, 45066, United States

  • DSI Research Northridge LLC

    RECRUITING

    Dayton, Ohio, 45414, United States

  • Delta Gastroenterology and Endoscopy Center

    RECRUITING

    Southaven, Mississippi, 38671, United States

  • Digestive Disease Medicine

    RECRUITING

    Utica, New York, 13502, United States

  • Digestive Health Institute

    WITHDRAWN

    Newport Beach, California, 92663, United States

  • Digestive Healthcare of Georgia

    RECRUITING

    Atlanta, Georgia, 30327, United States

  • Digestive Research of Central Texas, LLC

    RECRUITING

    Waco, Texas, 76712, United States

  • Digestive and Liver Center of Florida

    WITHDRAWN

    Orlando, Florida, 32825, United States

  • Digestive and Liver Center of Florida, P.A.

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Doral Medical Research, LLC

    WITHDRAWN

    Hialeah, Florida, 33016, United States

  • East View Medical Research

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Endoscopic Research, Inc.

    RECRUITING

    Orlando, Florida, 32803, United States

  • Five Towns Gastroenterology

    RECRUITING

    Cedarhurst, New York, 11516, United States

  • GI Alliance

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • GI Alliance

    RECRUITING

    Bellevue, Washington, 98405, United States

  • GI Alliance - Glenview

    RECRUITING

    Glenview, Illinois, 60026, United States

  • GI Alliance - Webster

    RECRUITING

    Webster, Texas, 77598, United States

  • GI Alliance- Sun City

    RECRUITING

    Sun City, Arizona, 85351, United States

  • GI Associates Research, LLC

    RECRUITING

    Columbia, Missouri, 65201, United States

  • GI Partners of Illinois - Southwest Gastroenterology

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Gastro Florida

    RECRUITING

    Clearwater, Florida, 33762, United States

  • Gastro Health

    RECRUITING

    Birmingham, Alabama, 35243, United States

  • Gastro Health & Nutrition

    RECRUITING

    Katy, Texas, 77494, United States

  • Gastro Health Research - Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Gastro Health Research - Framingham

    RECRUITING

    Framingham, Massachusetts, 01702, United States

  • Gastro Health Research - Liberty Township

    RECRUITING

    Liberty Township, Ohio, 45044, United States

  • Gastro Health Research - Miami

    RECRUITING

    Miami, Florida, 33176, United States

  • Gastro Health Research - Pensacola

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Gastroenterology Associates of Western Michigan, P.L.C.

    RECRUITING

    Wyoming, Michigan, 49519, United States

  • Gastroenterology Consultants of Southwest Virginia.

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Gastroenterology Group of Rochester

    WITHDRAWN

    Rochester, New York, 14620, United States

  • Gastroenterology and Internal Medicine Specialists, SC

    RECRUITING

    Lake Barrington, Illinois, 60010, United States

  • Gastroenterology and Liver Institute

    RECRUITING

    Escondido, California, 92025, United States

  • Great Lakes Gastroenterology Research, LLC

    RECRUITING

    Mentor, Ohio, 44060, United States

  • Huron Gastro

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Hutchinson Clinic

    RECRUITING

    Hutchinson, Kansas, 67502, United States

  • IMIDeology

    RECRUITING

    Elmhurst, New York, 11373, United States

  • Inland Empire Gastroenterology

    WITHDRAWN

    Murrieta, California, 92562, United States

  • Integrity Advanced Therapeutics

    WITHDRAWN

    Houston, Texas, 77090, United States

  • Intercity Gastroenterology

    RECRUITING

    Fresh Meadows, New York, 11040, United States

  • Kelsey Research Foundation

    RECRUITING

    Houston, Texas, 77005, United States

  • Knowledge Research Center

    WITHDRAWN

    Orange, California, 92868, United States

  • Lenox Hill Hospital

    WITHDRAWN

    New York, New York, 10075, United States

  • Lucida Clinical Trials LLC

    RECRUITING

    New Bedford, Massachusetts, 02740, United States

  • MNGI Digestive Health, P.A.

    WITHDRAWN

    Plymouth, Minnesota, 55446, United States

  • Manhattan Clinical Research, LLC

    WITHDRAWN

    New York, New York, 10279, United States

  • MedCare Pharma LLC

    RECRUITING

    Houston, Texas, 77079, United States

  • Medical Associates Research Group, Inc.

    WITHDRAWN

    San Diego, California, 92123, United States

  • Mid America Gastro Intestinal Consultants

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • NYU Langone Long Island Clinical Research Associates

    WITHDRAWN

    Lake Success, New York, 11042, United States

  • New York Gastroenterology Associates

    RECRUITING

    New York, New York, 10075, United States

  • NorthShore Gastroenterology Research, LLC

    RECRUITING

    Westlake, Ohio, 44145, United States

  • One of a Kind Clinical Research Center LLC

    RECRUITING

    Kingwood, Texas, 77339, United States

  • Orlando Health-Orlando Regional Medical Center

    RECRUITING

    Orlando, Florida, 32806, United States

  • Palmetto Primary Care Physician Division of Gastroenterology

    RECRUITING

    Summerville, South Carolina, 29486, United States

  • Peak Gastroenterology Associates

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Piedmont Healthcare

    RECRUITING

    Statesville, North Carolina, 28625, United States

  • Pinehurst Medical Clinic Inc

    WITHDRAWN

    Pinehurst, North Carolina, 28374, United States

  • Portland Gastroenterology Center

    RECRUITING

    Portland, Maine, 04101, United States

  • Presbyterian Health care services

    WITHDRAWN

    Albuquerque, New Mexico, 87107, United States

  • ProHealth (Seaford) (Optum)

    RECRUITING

    Seaford, New York, 11783, United States

  • Rockford Gastroenterology Associates, Ltd.

    RECRUITING

    Rockford, Illinois, 61107, United States

  • Rocky Mountain Endocopy Centers LLC

    RECRUITING

    Littleton, Colorado, 80120, United States

  • SSM Health Medical Group

    RECRUITING

    Bridgeton, Missouri, 63044, United States

  • Sanford Center for Digestive Health

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Spectrum Research Institute LLC

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Spring Clinical Research

    RECRUITING

    Houston, Texas, 77090, United States

  • Springfield Clinic

    RECRUITING

    Springfield, Illinois, 62703, United States

  • St Charles Clinical Research

    RECRUITING

    Weldon Spring, Missouri, 63304, United States

  • Suburban Gastroenterology

    WITHDRAWN

    Naperville, Illinois, 60540, United States

  • Syracuse VA Medical Center

    WITHDRAWN

    Syracuse, New York, 13210, United States

  • TMPG Clinical Research

    WITHDRAWN

    Williamsburg, Virginia, 23188, United States

  • Texas Gastro Consultants

    WITHDRAWN

    Tomball, Texas, 77375, United States

  • The Clinical Trials Network CTNX LLC

    RECRUITING

    Orange City, Florida, 32763, United States

  • The Clinical Trials Network CTNX LLC

    RECRUITING

    El Paso, Texas, 79936, United States

  • The Oregon Clinic, P.C.

    RECRUITING

    Portland, Oregon, 97220, United States

  • Tri-Cities Gastroenterology

    RECRUITING

    Kingsport, Tennessee, 37663, United States

  • Tri-State Gastroenterology Associates

    RECRUITING

    Crestview Hills, Kentucky, 41017, United States

  • UAMS Health Gastroenterology Clinic

    WITHDRAWN

    Little Rock, Arkansas, 72205, United States

  • United Clinical Research Institute

    RECRUITING

    Murrieta, California, 92563, United States

  • University Gastroenterology

    RECRUITING

    Providence, Rhode Island, 02904, United States

  • West Central Gastroenterology d/b/a Gastro Florida

    RECRUITING

    Pinellas Park, Florida, 33781, United States

  • West Texas Research Institute

    RECRUITING

    Lubbock, Texas, 79424, United States

  • Westchester Putnam Gastroenterology PC

    RECRUITING

    Carmel, New York, 10512, United States

  • Wilmington Gastroenterology Associates

    RECRUITING

    Wilmington, North Carolina, 28403, United States

  • Woodholme Gastroenterology

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • Yapp, Rockford M.D. (Private Practice)

    RECRUITING

    Downers Grove, Illinois, 60515, United States

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