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

NCT06045754

This study is recruiting at 41 US sites in 21 states, according to its ClinicalTrials.gov record last updated .

Summary

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Crohn's Disease

Eligibility basics and study details

Study type
Interventional
Phase
Phase 4
Ages
18 to 70 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Takeda
Last updated on ClinicalTrials.gov
September 9, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Alabama · 1

  • Digestive Health Specialsits · Dothan, AL

Arizona · 1

  • GI Alliance Sun City · Sun City, AZ

California · 3

  • University of California San Diego Health (UCSD) · La Jolla, CA
  • Cedars-Sinai Medical Center · Los Angeles, CA
  • Hoag Hospital Newport Beach · Newport Beach, CA

Connecticut · 1

  • Medical Research Center of Connecticut, LLC · Hamden, CT

Florida · 3

  • Clinical Research of Osceola · Kissimmee, FL
  • Endoscopic Research Inc · Orlando, FL
  • Alliance Clinical Research of Tampa, LLC · Tampa, FL

Georgia · 1

  • Gastroenterology Consultants, P.C. · Roswell, GA

Illinois · 1

  • University of Chicago Medicine · Chicago, IL

Kansas · 2

  • University of Kansas Medical Center · Kansas City, KS
  • Cotton ONeil Clinical Research Center · Topeka, KS

Kentucky · 1

  • University of Louisville · Louisville, KY

Louisiana · 2

  • GI Alliance · Metairie, LA
  • Tulane University · New Orleans, LA

Michigan · 1

  • Huron Gastroenterology Associates, P.C. · Ypsilanti, MI

Missouri · 3

  • Mid-America Gastro-Intestinal Consultants · Kansas City, MO
  • BVL Clinical Research · Liberty, MO
  • Washington University School of Medicine · St Louis, MO

New York · 1

  • NYU Langone Health · New York, NY

Ohio · 4

  • University of Cincinnati · Cincinnati, OH
  • Ohio Gastroenterology group, Inc. · Columbus, OH
  • Great Lakes Gastroenterology Research, LLC · Mentor, OH
  • Gastro Intestinal Research Institute of Northern Ohio, LLC. · Westlake, OH

Oklahoma · 1

  • Digestive Disease Specialists, Inc. · Oklahoma City, OK

Pennsylvania · 1

  • Allegheny Health Network · Wexford, PA

Rhode Island · 1

  • University Gastroenterology · Providence, RI

South Dakota · 1

  • Sanford Health Research · Rapid City, SD

Texas · 10

  • Texas Digestive Disease Consultants Cedar Park · Cedar Park, TX
  • GI Alliance - Digestive Health Associates of Texas · Dallas, TX
  • The University of Texas Health Science Center at Houston · Houston, TX
  • Texas Digestive Disease Consultants Lubbock · Lubbock, TX
  • GI Alliance - Mansfield · Mansfield, TX
  • Gastroenterology Research of San Antonio, LLC · San Antonio, TX
  • Southern Star Research Institute, LLC. · San Antonio, TX
  • Texas Digestive Disease Consultants (TDDC), Southlake · Southlake, TX
  • Tyler Research Institute, LLC · Tyler, TX
  • GI Alliance - Webster · Webster, TX

Utah · 1

  • University of Utah Health · Salt Lake City, UT

Washington · 1

  • Washington Gastroenterology- GIA · Tacoma, WA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.