RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-04-18
Study Completion:2027-06-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06045754

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.
  2. 2. Has moderately to severely active CD at Screening, defined as SES-CD \>=6 (\>=4 if isolated ileal disease).
  3. 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:
  4. 1. Inadequate response after completing the full induction regimen;
  5. 2. Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
  6. 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).
  7. 4. In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.
  1. 1. CDAI score \> 450.
  2. 2. A current diagnosis of ulcerative colitis or indeterminate colitis.
  3. 3. Clinical evidence of an abdominal abscess.
  4. 4. Known fistula (other than perianal fistula) or phlegmon.
  5. 5. Known perianal fistula with abscess.
  6. 6. Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
  7. 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. 8. Short bowel syndrome.
  9. 9. Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.
  10. 10. History or evidence of adenomatous colonic polyps that have not been removed.
  11. 11. History or evidence of colonic mucosal dysplasia.
  12. 12. Intolerance or contraindication to ileocolonoscopy.
  13. 13. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection).
  14. 14. Active or latent tuberculosis (TB), regardless of treatment history.
  15. 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. 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. 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. 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.

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

Digestive Health Specialsits
Dothan, Alabama, 36301
United States
GI Alliance Sun City
Sun City, Arizona, 85351
United States
University of California San Diego Health (UCSD)
La Jolla, California, 92037
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Hoag Hospital Newport Beach
Newport Beach, California, 92663
United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
United States
Endoscopic Research Inc
Orlando, Florida, 32803
United States
Alliance Clinical Research of Tampa, LLC
Tampa, Florida, 33615
United States
Gastroenterology Consultants, P.C.
Roswell, Georgia, 30076
United States
University of Chicago Medicine
Chicago, Illinois, 60637
United States
GI Alliance - Illinois Gastroenterology Group - Glenview
Glenview, Illinois, 60026
United States
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Gurnee, Illinois, 60031
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Cotton ONeil Clinical Research Center
Topeka, Kansas, 66606
United States
University of Louisville
Louisville, Kentucky, 40202
United States
GI Alliance
Metairie, Louisiana, 70006
United States
Tulane University
New Orleans, Louisiana, 70112
United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, 48038
United States
Huron Gastroenterology Associates, P.C.
Ypsilanti, Michigan, 48197
United States
Mid-America Gastro-Intestinal Consultants
Kansas City, Missouri, 64111
United States
BVL Clinical Research
Liberty, Missouri, 64068
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
NYU Langone Health
New York, New York, 10016
United States
University of Cincinnati
Cincinnati, Ohio, 45627
United States
Ohio Gastroenterology group, Inc.
Columbus, Ohio, 43202
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
United States
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Westlake, Ohio, 44145
United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73114
United States
Allegheny Health Network
Wexford, Pennsylvania, 15090
United States
University Gastroenterology
Providence, Rhode Island, 02905
United States
Rapid City Medical Center, LLP
Rapid City, South Dakota, 57701
United States
Texas Digestive Disease Consultants Cedar Park
Cedar Park, Texas, 78613
United States
GI Alliance - Digestive Health Associates of Texas
Dallas, Texas, 75044
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Texas Digestive Disease Consultants Lubbock
Lubbock, Texas, 79410
United States
GI Alliance - Mansfield
Mansfield, Texas, 76063
United States
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas, 78229
United States
Southern Star Research Institute, LLC.
San Antonio, Texas, 78229
United States
Texas Digestive Disease Consultants (TDDC), Southlake
Southlake, Texas, 76092
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
GI Alliance - Webster
Webster, Texas, 77598
United States
University of Utah Health
Salt Lake City, Utah, 84108
United States
Washington Gastroenterology- GIA
Bellevue, Washington, 98004
United States
Washington Gastroenterology- GIA
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18
Study Completion Date2027-06-28

Study Record Updates

Study Start Date2024-04-18
Study Completion Date2027-06-28

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy

Additional Relevant MeSH Terms

  • Crohn's Disease