A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

ClinicalTrials.gov ID: NCT06581328

Public ClinicalTrials.gov record NCT06581328. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 4:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.

Study identification

NCT ID: NCT06581328
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 4
Lead sponsor: Takeda; Industry
Enrollment: 400 participants

Conditions and interventions

Conditions

Interventions

Vedolizumab IV Drug
Vedolizumab SC Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 26, 2025
Primary completion: Sep 30, 2027
Completion: May 31, 2028
Last update posted: Aug 13, 2026

2025 – 2028

United States locations

U.S. sites: 101
U.S. states: 32
U.S. cities: 92

Facility	City	State	ZIP	Site status
Gastro Health	Birmingham	Alabama	35243	Recruiting
East View Medical Research	Mobile	Alabama	36608	Recruiting
AZ Gastro Care	Chandler	Arizona	85225	Recruiting
Spectrum Research Institute LLC	Gilbert	Arizona	85297	Recruiting
GI Alliance- Sun City	Sun City	Arizona	85351	Recruiting
UAMS Health Gastroenterology Clinic	Little Rock	Arkansas	72205	Withdrawn
Gastroenterology and Liver Institute	Escondido	California	92025	Recruiting
Inland Empire Gastroenterology	Murrieta	California	92562	Withdrawn
United Clinical Research Institute	Murrieta	California	92563	Recruiting
Digestive Health Institute	Newport Beach	California	92663	Withdrawn
Knowledge Research Center	Orange	California	92868	Withdrawn
Medical Associates Research Group, Inc.	San Diego	California	92123	Withdrawn
Peak Gastroenterology Associates	Colorado Springs	Colorado	80907	Recruiting
Rocky Mountain Endocopy Centers LLC	Littleton	Colorado	80120	Recruiting
Access Research Institute	Brooksville	Florida	34613	Recruiting
Gastro Florida	Clearwater	Florida	33762	Recruiting
Doral Medical Research, LLC	Hialeah	Florida	33016	Withdrawn
Digestive and Liver Center of Florida, P.A.	Kissimmee	Florida	34741	Recruiting
Gastro Health Research - Miami	Miami	Florida	33176	Recruiting
The Clinical Trials Network CTNX LLC	Orange City	Florida	32763	Recruiting
Endoscopic Research, Inc.	Orlando	Florida	32803	Recruiting
Orlando Health-Orlando Regional Medical Center	Orlando	Florida	32806	Recruiting
Digestive and Liver Center of Florida	Orlando	Florida	32825	Withdrawn
Gastro Health Research - Pensacola	Pensacola	Florida	32504	Recruiting
West Central Gastroenterology d/b/a Gastro Florida	Pinellas Park	Florida	33781	Recruiting
Digestive Healthcare of Georgia	Atlanta	Georgia	30327	Recruiting
AGA GA Research LLC	Atlanta	Georgia	30342	Recruiting
Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia	30033	Withdrawn
Yapp, Rockford M.D. (Private Practice)	Downers Grove	Illinois	60515	Recruiting
GI Alliance - Glenview	Glenview	Illinois	60026	Recruiting
Gastroenterology and Internal Medicine Specialists, SC	Lake Barrington	Illinois	60010	Recruiting
Suburban Gastroenterology	Naperville	Illinois	60540	Withdrawn
GI Partners of Illinois - Southwest Gastroenterology	Oak Lawn	Illinois	60453	Recruiting
Rockford Gastroenterology Associates, Ltd.	Rockford	Illinois	61107	Recruiting
Springfield Clinic	Springfield	Illinois	62703	Recruiting
Hutchinson Clinic	Hutchinson	Kansas	67502	Recruiting
Tri-State Gastroenterology Associates	Crestview Hills	Kentucky	41017	Recruiting
Baton Rouge General Medical Center - Bluebonnet Campus	Baton Rouge	Louisiana	70809	Recruiting
Combined Gastro LLC	Lafayette	Louisiana	70503	Recruiting
GI Alliance	Metairie	Louisiana	70006	Recruiting
Portland Gastroenterology Center	Portland	Maine	04101	Recruiting
Capital Digestive Care	Chevy Chase	Maryland	20815	Recruiting
Woodholme Gastroenterology	Glen Burnie	Maryland	21061	Recruiting
Gastro Health Research - Framingham	Framingham	Massachusetts	01702	Recruiting
Lucida Clinical Trials LLC	New Bedford	Massachusetts	02740	Recruiting
Gastroenterology Associates of Western Michigan, P.L.C.	Wyoming	Michigan	49519	Recruiting
Huron Gastro	Ypsilanti	Michigan	48197	Recruiting
MNGI Digestive Health, P.A.	Plymouth	Minnesota	55446	Withdrawn
Delta Gastroenterology and Endoscopy Center	Southaven	Mississippi	38671	Recruiting
SSM Health Medical Group	Bridgeton	Missouri	63044	Recruiting
GI Associates Research, LLC	Columbia	Missouri	65201	Recruiting
Mid America Gastro Intestinal Consultants	Kansas City	Missouri	64111	Recruiting
St Charles Clinical Research	Weldon Spring	Missouri	63304	Recruiting
Advanced Research Institute	Reno	Nevada	89511	Withdrawn
Presbyterian Health care services	Albuquerque	New Mexico	87107	Withdrawn
Westchester Putnam Gastroenterology PC	Carmel	New York	10512	Recruiting
Five Towns Gastroenterology	Cedarhurst	New York	11516	Recruiting
IMIDeology	Elmhurst	New York	11373	Recruiting
Intercity Gastroenterology	Fresh Meadows	New York	11040	Recruiting
NYU Langone Long Island Clinical Research Associates	Lake Success	New York	11042	Withdrawn
Lenox Hill Hospital	New York	New York	10075	Withdrawn
New York Gastroenterology Associates	New York	New York	10075	Recruiting
Manhattan Clinical Research, LLC	New York	New York	10279	Withdrawn
Gastroenterology Group of Rochester	Rochester	New York	14620	Withdrawn
ProHealth (Seaford) (Optum)	Seaford	New York	11783	Recruiting
Syracuse VA Medical Center	Syracuse	New York	13210	Withdrawn
Digestive Disease Medicine	Utica	New York	13502	Recruiting
Crystal Run (Optum)	West Nyack	New York	10994	Active, not recruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C	Charlotte	North Carolina	28207	Recruiting
Carolina Digestive Diseases	Greenville	North Carolina	27834	Recruiting
Pinehurst Medical Clinic Inc	Pinehurst	North Carolina	28374	Withdrawn
Piedmont Healthcare	Statesville	North Carolina	28625	Recruiting
Wilmington Gastroenterology Associates	Wilmington	North Carolina	28403	Recruiting
Gastro Health Research - Cincinnati	Cincinnati	Ohio	45219	Recruiting
DSI Research Northridge LLC	Dayton	Ohio	45414	Recruiting
Gastro Health Research - Liberty Township	Liberty Township	Ohio	45044	Recruiting
Great Lakes Gastroenterology Research, LLC	Mentor	Ohio	44060	Recruiting
DSI Research LLC	Springboro	Ohio	45066	Recruiting
NorthShore Gastroenterology Research, LLC	Westlake	Ohio	44145	Recruiting
The Oregon Clinic, P.C.	Portland	Oregon	97220	Recruiting
University Gastroenterology	Providence	Rhode Island	02904	Recruiting
Palmetto Primary Care Physician Division of Gastroenterology	Summerville	South Carolina	29486	Recruiting
Sanford Center for Digestive Health	Sioux Falls	South Dakota	57105	Recruiting
Tri-Cities Gastroenterology	Kingsport	Tennessee	37663	Recruiting
The Clinical Trials Network CTNX LLC	El Paso	Texas	79936	Recruiting
Amel Med LLC	Georgetown	Texas	78628	Recruiting
Kelsey Research Foundation	Houston	Texas	77005	Recruiting
MedCare Pharma LLC	Houston	Texas	77079	Recruiting
Integrity Advanced Therapeutics	Houston	Texas	77090	Withdrawn
Spring Clinical Research	Houston	Texas	77090	Recruiting
Gastro Health & Nutrition	Katy	Texas	77494	Recruiting
One of a Kind Clinical Research Center LLC	Kingwood	Texas	77339	Recruiting
West Texas Research Institute	Lubbock	Texas	79424	Recruiting
Texas Gastro Consultants	Tomball	Texas	77375	Withdrawn
Digestive Research of Central Texas, LLC	Waco	Texas	76712	Recruiting
GI Alliance - Webster	Webster	Texas	77598	Recruiting
Advanced Research Institute	Ogden	Utah	84405	Withdrawn
Gastroenterology Consultants of Southwest Virginia.	Roanoke	Virginia	24014	Recruiting
Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research	Suffolk	Virginia	23435	Withdrawn
TMPG Clinical Research	Williamsburg	Virginia	23188	Withdrawn
GI Alliance	Bellevue	Washington	98405	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06581328, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 13, 2026 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06581328 live on ClinicalTrials.gov.

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