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

RecruitingPhase 4

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)

Who can join

Ages 18 to 70 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Takeda · Participants: 50 · Started: Apr 18, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06045754

Locations in the U.S.

AlabamaDigestive Health Specialsits, Dothan
ArizonaGI Alliance Sun City, Sun City
CaliforniaUniversity of California San Diego Health (UCSD), La Jolla
Cedars-Sinai Medical Center, Los Angeles
Hoag Hospital Newport Beach, Newport Beach
ConnecticutMedical Research Center of Connecticut, LLC, Hamden
FloridaClinical Research of Osceola, Kissimmee
Endoscopic Research Inc, Orlando
Alliance Clinical Research of Tampa, LLC, Tampa
GeorgiaGastroenterology Consultants, P.C., Roswell
IllinoisUniversity of Chicago Medicine, Chicago
KansasUniversity of Kansas Medical Center, Kansas City
Cotton ONeil Clinical Research Center, Topeka
KentuckyUniversity of Louisville, Louisville
LouisianaGI Alliance, Metairie
Tulane University, New Orleans
MichiganHuron Gastroenterology Associates, P.C., Ypsilanti
MissouriMid-America Gastro-Intestinal Consultants, Kansas City
BVL Clinical Research, Liberty
Washington University School of Medicine, St Louis
New YorkNYU Langone Health, New York
OhioUniversity of Cincinnati, Cincinnati
Ohio Gastroenterology group, Inc., Columbus
Great Lakes Gastroenterology Research, LLC, Mentor
Gastro Intestinal Research Institute of Northern Ohio, LLC., Westlake
OklahomaDigestive Disease Specialists, Inc., Oklahoma City
PennsylvaniaAllegheny Health Network, Wexford
Rhode IslandUniversity Gastroenterology, Providence
South DakotaSanford Health Research, Rapid City
TexasTexas Digestive Disease Consultants Cedar Park, Cedar Park
GI Alliance - Digestive Health Associates of Texas, Dallas
The University of Texas Health Science Center at Houston, Houston
Texas Digestive Disease Consultants Lubbock, Lubbock
GI Alliance - Mansfield, Mansfield
Gastroenterology Research of San Antonio, LLC, San Antonio
Southern Star Research Institute, LLC., San Antonio
Texas Digestive Disease Consultants (TDDC), Southlake, Southlake
Tyler Research Institute, LLC, Tyler
GI Alliance - Webster, Webster
UtahUniversity of Utah Health, Salt Lake City
WashingtonWashington Gastroenterology- GIA, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.