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Clinical Trials in the USA / NCT06045754
Recruiting Phase 4

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

NCT06045754 · tracked via the Priya Life Science USA tracker
Sponsor
Takeda
Phase
Phase 4
Started
2024-04-18
Last updated
2026-09-09

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

VedolizumabAdalimumabUstekinumabUstekinumab

Vedolizumab: Vedolizumab intravenous infusion.

Adalimumab: Adalimumab subcutaneous injection.

Ustekinumab: Ustekinumab intravenous infusion.

Ustekinumab: Ustekinumab subcutaneous injection.

Study 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. Part B will include participants who responded to the treatment in Part A.

Each participant will be followed up for at least 26 weeks after the last dose of treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: Part A: 1. Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results. 2. Has moderately to severely active CD at Screening, defined as an SES-CD \>=6 (\>=4 if isolated ileal disease). 3. Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD: 1. Inadequate response after completing the full induction regimen; 2. Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or 3. Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury). Note: Participants with an inadequate response to \>2 classes of advanced therapies or \>1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor. Part B: 4. In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26. Exclusion Criteria: 1. CDAI score \> 450. 2. A current diagnosis of ulcerative colitis or indeterminate colitis. 3. Clinical evidence of an abdominal abscess. 4. Known fistula (other than perianal fistula) or phlegmon. 5. Known perianal fistula with abscess. 6. Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine. 7. Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. 8. Short bowel syndrome. 9. Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess. 10. History or evidence of adenomatous colonic polyps that have not been removed. 11. History or evidence of colonic mucosal dysplasia. 12. Intolerance or contraindication to ileocolonoscopy. 13. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection). 14. Active or latent tuberculosis (TB), regardless of treatment history. 15. A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test. 16. A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA). 17. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\], anti- mucosal addressin cell adhesion molecule-1 \[MAdCAM-1\] antibodies, or rituximab) for the treatment of CD. 18. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. If a participant has symptoms consistent with PML, a PML checklist must be completed and submitted to the PML independent adjudication committee. If the PML IAC deems the participant to have PML, the participant is ineligible.

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
Digestive Health Specialsits Dothan Alabama Recruiting
GI Alliance Sun City Sun City Arizona Recruiting
University of California San Diego Health (UCSD) La Jolla California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Hoag Hospital Newport Beach Newport Beach California Recruiting
Medical Research Center of Connecticut, LLC Hamden Connecticut Recruiting
Clinical Research of Osceola Kissimmee Florida Recruiting
Endoscopic Research Inc Orlando Florida Recruiting
Alliance Clinical Research of Tampa, LLC Tampa Florida Recruiting
Gastroenterology Consultants, P.C. Roswell Georgia Recruiting
University of Chicago Medicine Chicago Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Cotton ONeil Clinical Research Center Topeka Kansas Recruiting
University of Louisville Louisville Kentucky Recruiting
GI Alliance Metairie Louisiana Recruiting
Tulane University New Orleans Louisiana Recruiting
Huron Gastroenterology Associates, P.C. Ypsilanti Michigan Recruiting
Mid-America Gastro-Intestinal Consultants Kansas City Missouri Recruiting
BVL Clinical Research Liberty Missouri Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
NYU Langone Health New York New York Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Ohio Gastroenterology group, Inc. Columbus Ohio Recruiting
Great Lakes Gastroenterology Research, LLC Mentor Ohio Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC. Westlake Ohio Recruiting
Digestive Disease Specialists, Inc. Oklahoma City Oklahoma Recruiting
Allegheny Health Network Wexford Pennsylvania Recruiting
University Gastroenterology Providence Rhode Island Recruiting
Sanford Health Research Rapid City South Dakota Recruiting
Texas Digestive Disease Consultants Cedar Park Cedar Park Texas Recruiting
GI Alliance - Digestive Health Associates of Texas Dallas Texas Recruiting
The University of Texas Health Science Center at Houston Houston Texas Recruiting
Texas Digestive Disease Consultants Lubbock Lubbock Texas Recruiting
GI Alliance - Mansfield Mansfield Texas Recruiting
Gastroenterology Research of San Antonio, LLC San Antonio Texas Recruiting
Southern Star Research Institute, LLC. San Antonio Texas Recruiting
Texas Digestive Disease Consultants (TDDC), Southlake Southlake Texas Recruiting
Tyler Research Institute, LLC Tyler Texas Recruiting
GI Alliance - Webster Webster Texas Recruiting
University of Utah Health Salt Lake City Utah Recruiting

+ 8 more sites — see the full list on the official registry below.

On this site

📄 Entyvio (vedolizumab) drug profile → 📄 Humira (adalimumab) drug profile → 📄 Stelara (ustekinumab) drug profile →

More Takeda trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06045754 on ClinicalTrials.gov ↗ ← All trials in the USA