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

NCT ID NCT06581328

Recruiting now Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 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.

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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

Contacts and locations

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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WITHDRAWN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WITHDRAWN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WITHDRAWN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)
ACTIVE_NOT_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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