A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

ClinicalTrials.gov ID: NCT06045754

Public ClinicalTrials.gov record NCT06045754. 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 Jul 22, 2026, 10:28 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

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)

Study identification

NCT ID: NCT06045754
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 4
Lead sponsor: Takeda; Industry
Enrollment: 100 participants

Conditions and interventions

Conditions

Crohn's Disease

Interventions

Vedolizumab Drug
Adalimumab Drug
Ustekinumab Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 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: Apr 17, 2024
Primary completion: Jun 27, 2027
Completion: Jun 27, 2027
Last update posted: Jul 7, 2026

2024 – 2027

United States locations

U.S. sites: 44
U.S. states: 21
U.S. cities: 43

Facility	City	State	ZIP	Site status
Digestive Health Specialsits	Dothan	Alabama	36301	Recruiting
GI Alliance Sun City	Sun City	Arizona	85351	Recruiting
University of California San Diego Health (UCSD)	La Jolla	California	92037	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	90048	Recruiting
Hoag Hospital Newport Beach	Newport Beach	California	92663	Recruiting
Medical Research Center of Connecticut, LLC	Hamden	Connecticut	06518	Recruiting
Clinical Research of Osceola	Kissimmee	Florida	34741	Active, not recruiting
Endoscopic Research Inc	Orlando	Florida	32803	Recruiting
Alliance Clinical Research of Tampa, LLC	Tampa	Florida	33615	Recruiting
Gastroenterology Consultants, P.C.	Roswell	Georgia	30076	Recruiting
University of Chicago Medicine	Chicago	Illinois	60637	Recruiting
GI Alliance - Illinois Gastroenterology Group - Glenview	Glenview	Illinois	60026	Recruiting
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee	Gurnee	Illinois	60031	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	66160	Recruiting
Cotton ONeil Clinical Research Center	Topeka	Kansas	66606	Recruiting
University of Louisville	Louisville	Kentucky	40202	Recruiting
GI Alliance	Metairie	Louisiana	70006	Recruiting
Tulane University	New Orleans	Louisiana	70112	Recruiting
Huron Gastroenterology Associates, P.C.	Ypsilanti	Michigan	48197	Recruiting
Mid-America Gastro-Intestinal Consultants	Kansas City	Missouri	64111	Recruiting
BVL Clinical Research	Liberty	Missouri	64068	Recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting
University of Cincinnati	Cincinnati	Ohio	45627	Recruiting
Ohio Gastroenterology group, Inc.	Columbus	Ohio	43202	Recruiting
Great Lakes Gastroenterology Research, LLC	Mentor	Ohio	44060	Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC.	Westlake	Ohio	44145	Recruiting
Digestive Disease Specialists, Inc.	Oklahoma City	Oklahoma	73114	Recruiting
Allegheny Health Network	Wexford	Pennsylvania	15090	Recruiting
University Gastroenterology	Providence	Rhode Island	02094	Recruiting
Sanford Health Research	Rapid City	South Dakota	57701	Recruiting
Texas Digestive Disease Consultants Cedar Park	Cedar Park	Texas	78613	Recruiting
GI Alliance - Digestive Health Associates of Texas	Dallas	Texas	75044	Recruiting
The University of Texas Health Science Center at Houston	Houston	Texas	77030	Recruiting
Texas Digestive Disease Consultants Lubbock	Lubbock	Texas	79410	Recruiting
GI Alliance - Mansfield	Mansfield	Texas	76063	Recruiting
Gastroenterology Research of San Antonio, LLC	San Antonio	Texas	78229	Recruiting
Southern Star Research Institute, LLC.	San Antonio	Texas	78229	Recruiting
Texas Digestive Disease Consultants (TDDC), Southlake	Southlake	Texas	76092	Recruiting
Tyler Research Institute, LLC	Tyler	Texas	75701	Recruiting
GI Alliance - Webster	Webster	Texas	77598	Recruiting
University of Utah Health	Salt Lake City	Utah	84108	Recruiting
Washington Gastroenterology- GIA	Bellevue	Washington	98004	Withdrawn
Washington Gastroenterology- GIA	Tacoma	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.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06045754, 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 Jul 7, 2026 · Synced Jul 22, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06045754 live on ClinicalTrials.gov.

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