Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
NCT06045754

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

Led by Takeda · Updated on 2026-03-18

100

Participants Needed

54

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 54 locations

1

Digestive Health Specialsits

Dothan, Alabama, United States, 36301

Actively Recruiting

2

GI Alliance Sun City

Sun City, Arizona, United States, 85351

Actively Recruiting

3

University of California San Diego Health (UCSD)

La Jolla, California, United States, 92037

Actively Recruiting

4

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

5

Hoag Hospital Newport Beach

Newport Beach, California, United States, 92663

Actively Recruiting

6

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States, 06518

Actively Recruiting

7

Clinical Research of Osceola

Kissimmee, Florida, United States, 34741

Actively Recruiting

8

Endoscopic Research Inc

Orlando, Florida, United States, 32803

Actively Recruiting

9

University of South Florida

Tampa, Florida, United States, 33612

Not Yet Recruiting

10

Alliance Clinical Research of Tampa, LLC

Tampa, Florida, United States, 33615

Actively Recruiting

11

Gastroenterology Consultants, P.C.

Roswell, Georgia, United States, 30076

Actively Recruiting

12

University of Chicago Medicine

Chicago, Illinois, United States, 60637

Actively Recruiting

13

GI Alliance - Illinois Gastroenterology Group - Glenview

Glenview, Illinois, United States, 60026

Actively Recruiting

14

GI Alliance - Illinois Gastroenterology Group LLC - Gurnee

Gurnee, Illinois, United States, 60031

Actively Recruiting

15

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

16

Cotton ONeil Clinical Research Center

Topeka, Kansas, United States, 66606

Actively Recruiting

17

University of Louisville

Louisville, Kentucky, United States, 40202

Actively Recruiting

18

GI Alliance

Metairie, Louisiana, United States, 70006

Actively Recruiting

19

Tulane University

New Orleans, Louisiana, United States, 70112

Actively Recruiting

20

Huron Gastroenterology Associates, P.C.

Ypsilanti, Michigan, United States, 48197

Actively Recruiting

21

Mid-America Gastro-Intestinal Consultants

Kansas City, Missouri, United States, 64111

Actively Recruiting

22

BVL Clinical Research

Liberty, Missouri, United States, 64068

Actively Recruiting

23

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

24

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

25

University of Cincinnati

Cincinnati, Ohio, United States, 45627

Actively Recruiting

26

Ohio Gastroenterology group, Inc.

Columbus, Ohio, United States, 43202

Actively Recruiting

27

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States, 44060

Actively Recruiting

28

Gastro Intestinal Research Institute of Northern Ohio, LLC.

Westlake, Ohio, United States, 44145

Actively Recruiting

29

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, United States, 73114

Actively Recruiting

30

Allegheny Health Network

Wexford, Pennsylvania, United States, 15090

Actively Recruiting

31

University Gastroenterology

Providence, Rhode Island, United States, 02905

Actively Recruiting

32

Rapid City Medical Center, LLP

Rapid City, South Dakota, United States, 57701

Actively Recruiting

33

Texas Digestive Disease Consultants Cedar Park

Cedar Park, Texas, United States, 78613

Actively Recruiting

34

GI Alliance - Digestive Health Associates of Texas

Dallas, Texas, United States, 75044

Actively Recruiting

35

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

36

Texas Digestive Disease Consultants Lubbock

Lubbock, Texas, United States, 79410

Actively Recruiting

37

GI Alliance - Mansfield

Mansfield, Texas, United States, 76063

Actively Recruiting

38

Gastroenterology Research of San Antonio, LLC

San Antonio, Texas, United States, 78229

Actively Recruiting

39

Southern Star Research Institute, LLC.

San Antonio, Texas, United States, 78229

Actively Recruiting

40

Texas Digestive Disease Consultants (TDDC), Southlake

Southlake, Texas, United States, 76092

Actively Recruiting

41

Tyler Research Institute, LLC

Tyler, Texas, United States, 75701

Actively Recruiting

42

GI Alliance - Webster

Webster, Texas, United States, 77598

Actively Recruiting

43

University of Utah Health

Salt Lake City, Utah, United States, 84108

Actively Recruiting

44

Washington Gastroenterology- GIA

Bellevue, Washington, United States, 98004

Withdrawn

45

Washington Gastroenterology- GIA

Tacoma, Washington, United States, 98405

Actively Recruiting

46

Covenant Health

Edmonton, Alberta, Canada, T5K 2K4

Actively Recruiting

47

London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Actively Recruiting

48

West GTA Endoscopy Inc.

Mississauga, Ontario, Canada, L5M 7N4

Actively Recruiting

49

Viable Clinical Research - North Bay

North Bay, Ontario, Canada, P1B 2H3

Actively Recruiting

50

Toronto Immune and Digestive Health Institute Inc. (TIDHI)

North York, Ontario, Canada, M6A3B4

Actively Recruiting

51

ABP Research Services Corp.

Oakville, Ontario, Canada, L6L 5L7

Actively Recruiting

52

Taunton Surgical Centre

Oshawa, Ontario, Canada, L1J 0C7

Withdrawn

53

Toronto Digestive Disease Associates (TDDA) Inc.

Vaughan, Ontario, Canada, L4L 4Y7

Actively Recruiting

54

The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada, H3G 1A4

Actively Recruiting

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Research Team

T

Takeda Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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