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RECRUITING

NCT06045754

PHASE4

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

Sponsor: Takeda

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-04-18

Completion Date

2027-06-28

Last Updated

2026-03-18

Healthy Volunteers

Conditions

Crohn's Disease

Interventions

DRUG

Vedolizumab

Vedolizumab intravenous infusion.

DRUG

Adalimumab

Adalimumab subcutaneous injection.

DRUG

Ustekinumab

Ustekinumab intravenous infusion.

DRUG

Ustekinumab

Ustekinumab subcutaneous injection.

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.

Locations (54)

Digestive Health Specialsits

Dothan, Alabama, United States

GI Alliance Sun City

Sun City, Arizona, United States

University of California San Diego Health (UCSD)

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Hoag Hospital Newport Beach

Newport Beach, California, United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Clinical Research of Osceola

Kissimmee, Florida, United States

Endoscopic Research Inc

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Alliance Clinical Research of Tampa, LLC

Tampa, Florida, United States

Gastroenterology Consultants, P.C.

Roswell, Georgia, United States

University of Chicago Medicine

Chicago, Illinois, United States

GI Alliance - Illinois Gastroenterology Group - Glenview

Glenview, Illinois, United States

GI Alliance - Illinois Gastroenterology Group LLC - Gurnee

Gurnee, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Cotton ONeil Clinical Research Center

Topeka, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

GI Alliance

Metairie, Louisiana, United States

Tulane University

New Orleans, Louisiana, United States

Huron Gastroenterology Associates, P.C.

Ypsilanti, Michigan, United States

Mid-America Gastro-Intestinal Consultants

Kansas City, Missouri, United States

BVL Clinical Research

Liberty, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio Gastroenterology group, Inc.

Columbus, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Gastro Intestinal Research Institute of Northern Ohio, LLC.

Westlake, Ohio, United States

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, United States

Allegheny Health Network

Wexford, Pennsylvania, United States

University Gastroenterology

Providence, Rhode Island, United States

Rapid City Medical Center, LLP

Rapid City, South Dakota, United States

Texas Digestive Disease Consultants Cedar Park

Cedar Park, Texas, United States

GI Alliance - Digestive Health Associates of Texas

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Texas Digestive Disease Consultants Lubbock

Lubbock, Texas, United States

GI Alliance - Mansfield

Mansfield, Texas, United States

Gastroenterology Research of San Antonio, LLC

San Antonio, Texas, United States

Southern Star Research Institute, LLC.

San Antonio, Texas, United States

Texas Digestive Disease Consultants (TDDC), Southlake

Southlake, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

GI Alliance - Webster

Webster, Texas, United States

University of Utah Health

Salt Lake City, Utah, United States

Washington Gastroenterology- GIA

Bellevue, Washington, United States

Washington Gastroenterology- GIA

Tacoma, Washington, United States

Covenant Health

Edmonton, Alberta, Canada

London Health Sciences Centre

London, Ontario, Canada

West GTA Endoscopy Inc.

Mississauga, Ontario, Canada

Viable Clinical Research - North Bay

North Bay, Ontario, Canada

Toronto Immune and Digestive Health Institute Inc. (TIDHI)

North York, Ontario, Canada

ABP Research Services Corp.

Oakville, Ontario, Canada

Taunton Surgical Centre

Oshawa, Ontario, Canada

Toronto Digestive Disease Associates (TDDA) Inc.

Vaughan, Ontario, Canada

The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (54)