New study tests switch from IV to home injections for IBD

NCT ID NCT06581328

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

First seen Nov 01, 2025

Summary

This study is testing vedolizumab (Entyvio) in 400 adults with moderate to severe ulcerative colitis or Crohn's disease. Participants first receive the drug through an IV infusion for 6 weeks, then switch to injections under the skin for the rest of the year. The main goal is to see how many achieve remission (symptom relief) by week 14. The study is being done in community clinics to reflect real-world care.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

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Locations

AGA GA Research LLC
RECRUITING

Atlanta, Georgia, 30342, United States

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AZ Gastro Care
RECRUITING

Chandler, Arizona, 85225, United States

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Access Research Institute
RECRUITING

Brooksville, Florida, 34613, United States

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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WITHDRAWN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WITHDRAWN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

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Associates in Gastroenterology, PC
RECRUITING

Colorado Springs, Colorado, 80923, United States

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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WITHDRAWN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

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Capital Digestive Care
RECRUITING

Chevy Chase, Maryland, 20815, United States

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Carolina Digestive Diseases
ACTIVE_NOT_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

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Combined Gastro LLC
RECRUITING

Lafayette, Louisiana, 70503, United States

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DSI Research LLC
RECRUITING

Springboro, Ohio, 45066, United States

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DSI Research Northridge LLC
RECRUITING

Dayton, Ohio, 45414, United States

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Delta Gastroenterology and Endoscopy Center
RECRUITING

Southaven, Mississippi, 38671, United States

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Digestive Disease Medicine
RECRUITING

Utica, New York, 13502, United States

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Digestive Health Institute
WITHDRAWN

Newport Beach, California, 92663, United States
Digestive Healthcare of Georgia
RECRUITING

Atlanta, Georgia, 30327, United States

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Digestive Research of Central Texas, LLC
RECRUITING

Waco, Texas, 76712, United States

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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

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Doral Medical Research, LLC
WITHDRAWN

Hialeah, Florida, 33016, United States
East View Medical Research
RECRUITING

Mobile, Alabama, 36608, United States

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Endoscopic Research, Inc.
RECRUITING

Orlando, Florida, 32803, United States

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Five Towns Gastroenterology
ACTIVE_NOT_RECRUITING

Cedarhurst, New York, 11516, United States
GI Alliance
RECRUITING

Metairie, Louisiana, 70006, United States

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GI Alliance
RECRUITING

Bellevue, Washington, 98405, United States

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GI Alliance - Glenview
RECRUITING

Glenview, Illinois, 60026, United States

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GI Alliance - Webster
RECRUITING

Webster, Texas, 77598, United States

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GI Alliance- Sun City
RECRUITING

Sun City, Arizona, 85351, United States

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GI Associates Research, LLC
RECRUITING

Columbia, Missouri, 65201, United States

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GI Partners of Illinois - Southwest Gastroenterology
RECRUITING

Oak Lawn, Illinois, 60453, United States

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Gastro Florida
RECRUITING

Clearwater, Florida, 33762, United States

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Gastro Health & Nutrition
ACTIVE_NOT_RECRUITING

Katy, Texas, 77494, United States
Gastro Health Research - Cincinnati
RECRUITING

Cincinnati, Ohio, 45219, United States

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Gastro Health Research - Framingham
RECRUITING

Framingham, Massachusetts, 01702, United States

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Gastro Health Research - Liberty Township
RECRUITING

Liberty Township, Ohio, 45044, United States

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Gastro Health Research - Miami
RECRUITING

Miami, Florida, 33176, United States

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Gastro Health Research - Pensacola
RECRUITING

Pensacola, Florida, 32504, United States

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Gastro Health Research- St. Vincents East
RECRUITING

Birmingham, Alabama, 35235, United States

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

Wyoming, Michigan, 49519, United States

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Gastroenterology Consultants of Southwest Virginia.
RECRUITING

Roanoke, Virginia, 24014, United States

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Gastroenterology Group of Rochester
WITHDRAWN

Rochester, New York, 14620, United States
Gastroenterology and Internal Medicine Specialists, SC
RECRUITING

Lake Barrington, Illinois, 60010, United States

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Gastroenterology and Liver Institute
RECRUITING

Escondido, California, 92025, United States

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Great Lakes Gastroenterology Research, LLC
RECRUITING

Mentor, Ohio, 44060, United States

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Huron Gastro
RECRUITING

Ypsilanti, Michigan, 48197, United States

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Hutchinson Clinic
RECRUITING

Hutchinson, Kansas, 67502, United States

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IMIDeology
RECRUITING

Elmhurst, New York, 11373, United States

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Inland Empire Gastroenterology
WITHDRAWN

Murrieta, California, 92562, United States
Integrity Advanced Therapeutics
WITHDRAWN

Houston, Texas, 77090, United States
Intercity Gastroenterology
ACTIVE_NOT_RECRUITING

Fresh Meadows, New York, 11040, United States
Kelsey Research Foundation
RECRUITING

Houston, Texas, 77005, United States

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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

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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

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Medical Associates Research Group, Inc.
WITHDRAWN

San Diego, California, 92123, United States
Mid America Gastro Intestinal Consultants
RECRUITING

Kansas City, Missouri, 64111, United States

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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

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NorthShore Gastroenterology Research, LLC
RECRUITING

Westlake, Ohio, 44145, United States

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One of a Kind Clinical Research Center LLC
RECRUITING

Kingwood, Texas, 77339, United States

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Orlando Health-Orlando Regional Medical Center
RECRUITING

Orlando, Florida, 32806, United States

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Palmetto Primary Care Physician Division of Gastroenterology
RECRUITING

Summerville, South Carolina, 29486, United States

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Peak Gastroenterology Associates
RECRUITING

Colorado Springs, Colorado, 80907, United States

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Piedmont Healthcare
RECRUITING

Statesville, North Carolina, 28625, United States

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Pinehurst Medical Clinic Inc
WITHDRAWN

Pinehurst, North Carolina, 28374, United States
Portland Gastroenterology Center
RECRUITING

Portland, Maine, 04101, United States

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Presbyterian Health care services
WITHDRAWN

Albuquerque, New Mexico, 87107, United States
ProHealth (Seaford) (Optum)
RECRUITING

Seaford, New York, 11783, United States

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Rockford Gastroenterology Associates, Ltd.
RECRUITING

Rockford, Illinois, 61107, United States

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Rocky Mountain Endocopy Centers LLC
RECRUITING

Littleton, Colorado, 80120, United States

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SSM Health Medical Group
RECRUITING

Bridgeton, Missouri, 63044, United States

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Sanford Center for Digestive Health
RECRUITING

Sioux Falls, South Dakota, 57105, United States

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Spectrum Research Institute LLC
RECRUITING

Gilbert, Arizona, 85297, United States

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Spring Clinical Research
RECRUITING

Houston, Texas, 77090, United States

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Springfield Clinic
RECRUITING

Springfield, Illinois, 62703, United States

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St Charles Clinical Research
RECRUITING

Weldon Spring, Missouri, 63304, United States

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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

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The Clinical Trials Network CTNX LLC
RECRUITING

El Paso, Texas, 79936, United States

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The Oregon Clinic, P.C.
RECRUITING

Portland, Oregon, 97220, United States

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Tri-Cities Gastroenterology
RECRUITING

Kingsport, Tennessee, 37663, United States

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Tri-State Gastroenterology Associates
RECRUITING

Crestview Hills, Kentucky, 41017, United States

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UAMS Health Gastroenterology Clinic
WITHDRAWN

Little Rock, Arkansas, 72205, United States
United Clinical Research Institute
RECRUITING

Murrieta, California, 92563, United States

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University Gastroenterology
RECRUITING

Providence, Rhode Island, 02904, United States

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West Central Gastroenterology d/b/a Gastro Florida
RECRUITING

Pinellas Park, Florida, 33781, United States

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West Texas Research Institute
RECRUITING

Lubbock, Texas, 79424, United States

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Westchester Putnam Gastroenterology PC
RECRUITING

Carmel, New York, 10512, United States

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Wilmington Gastroenterology Associates
RECRUITING

Wilmington, North Carolina, 28403, United States

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Woodholme Gastroenterology
RECRUITING

Glen Burnie, Maryland, 21061, United States

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

Downers Grove, Illinois, 60515, United States

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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 confirm that switching from IV to at-home injections of vedolizumab is effective for controlling symptoms and achieving remission in people with inflammatory bowel disease.

What could go wrong

This is a single-arm study with no placebo, so results may be less conclusive. Not everyone responds to vedolizumab, and some may experience side effects like infections or allergic reactions.

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