A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
NCT ID: NCT06045754
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2024-04-18
2027-06-28
Brief Summary
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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.
Detailed Description
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The study will enroll approximately 100 participants. Participants will be assigned to one of the two treatment groups in Part A:
* Part A, Cohort 1: Vedolizumab + Adalimumab
* Part A, Cohort 2: Vedolizumab + Ustekinumab
All participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug).
This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A, Cohort 1: Vedolizumab + Adalimumab
Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then every 8 weeks (Q8W) until Week 22 and adalimumab SC 160, 80, and 40 mg at Weeks 0, 2, and 4, respectively, then 40 mg every 2 weeks (Q2W) until Week 26.
Vedolizumab
Vedolizumab intravenous infusion.
Adalimumab
Adalimumab subcutaneous injection.
Part A, Cohort 2: Vedolizumab + Ustekinumab
Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then Q8W until Week 22 and ustekinumab IV 520, 390, or 260 mg (weight-based), then SC 90 mg 8 weeks after initial IV dose, then Q8W until Week 24.
Vedolizumab
Vedolizumab intravenous infusion.
Ustekinumab
Ustekinumab intravenous infusion.
Ustekinumab
Ustekinumab subcutaneous injection.
Part B: Vedolizumab Monotherapy
Participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy, Q8W from Week 30 until Week 46 and will be followed up to Week 52.
Vedolizumab
Vedolizumab intravenous infusion.
Interventions
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Vedolizumab
Vedolizumab intravenous infusion.
Adalimumab
Adalimumab subcutaneous injection.
Ustekinumab
Ustekinumab intravenous infusion.
Ustekinumab
Ustekinumab subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
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
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 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
ABP Research Services Corp.
Oakville, Ontario, Canada
Taunton Surgical Centre
Oshawa, Ontario, Canada
Toronto Digestive Disease Associates (TDDA) Inc.
Vaughan, Ontario, Canada
McGill University Health Centre Montreal General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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MACS-2022-120102
Identifier Type: OTHER
Identifier Source: secondary_id
EXPLORER 2.0
Identifier Type: OTHER
Identifier Source: secondary_id
Vedolizumab-4051
Identifier Type: -
Identifier Source: org_study_id