Recruiting

Vedolizumab & Adalimumab

Sponsor:

Takeda

Code:

NCT06045754

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Vedolizumab

Adalimumab

Ustekinumab

Ustekinumab

Study Details

Brief 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.

Conditions

Crohn's Disease

Study ID

NCT06045754

Start date

Apr 18, 2024

Status verified date

Aug, 2026

Completion date

Jun 28, 2027

Anticipated

Primary completion date

Jun 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

Vedolizumab

Vedolizumab intravenous infusion.

Adalimumab

Adalimumab subcutaneous injection.

Ustekinumab

Ustekinumab intravenous infusion.

Ustekinumab

Ustekinumab subcutaneous injection.

Primary outcome measure

  • Part A: Percentage of Participants With an Endoscopic Response Based on the Simple Endoscopic Score for (SES-CD) at Week 26 [ Time Frame: At Week 26 ]
  • Part B: Percentage of Participants With an Endoscopic Response Based on the SES-CD at Week 52 [ Time Frame: At Week 52 ]

Central Contacts and Locations

Central contacts

Locations

Digestive Health Specialsits

Recruiting

Dothan, Alabama, United States, 36301

Contacts

Principal Investigator:

Robert Albares

GI Alliance Sun City

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Principal Investigator:

Chirag Trivedi

University of California San Diego Health (UCSD)

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Preetika Sinh

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Andres Yarur

Hoag Hospital Newport Beach

Recruiting

Newport Beach, California, United States, 92663

Contacts

Principal Investigator:

Caroline Hwang

Medical Research Center of Connecticut, LLC

Recruiting

Hamden, Connecticut, United States, 06518

Contacts

Principal Investigator:

Paul Feuerstadt

Clinical Research of Osceola

Recruiting

Kissimmee, Florida, United States, 34741

Contacts

Principal Investigator:

Basher Atiquzzaman

Endoscopic Research Inc

Recruiting

Orlando, Florida, United States, 32803

Contacts

Principal Investigator:

Henry Levine

Alliance Clinical Research of Tampa, LLC

Recruiting

Tampa, Florida, United States, 33615

Contacts

Principal Investigator:

Israel Crespo

Gastroenterology Consultants, P.C.

Recruiting

Roswell, Georgia, United States, 30076

Contacts

Principal Investigator:

Melvin Bullock

University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

David Rubin

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Tuba Esfandyari

Cotton ONeil Clinical Research Center

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Principal Investigator:

Curtis Baum

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Gerald Dryden

GI Alliance

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Principal Investigator:

George Catinis

Tulane University

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Principal Investigator:

Sarah Glover

Huron Gastroenterology Associates, P.C.

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Najm Soofi

Mid-America Gastro-Intestinal Consultants

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Principal Investigator:

Hillary Bownik

BVL Clinical Research

Recruiting

Liberty, Missouri, United States, 64068

Contacts

Principal Investigator:

Christopher Bartalos

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Parakkal Deepak

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

David Hudesman

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45627

Contacts

Principal Investigator:

Loren Brook

Ohio Gastroenterology group, Inc.

Recruiting

Columbus, Ohio, United States, 43202

Contacts

Principal Investigator:

Ryan Gaible

Great Lakes Gastroenterology Research, LLC

Recruiting

Mentor, Ohio, United States, 44060

Contacts

Principal Investigator:

Keith Alan Friedenberg

Gastro Intestinal Research Institute of Northern Ohio, LLC.

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Principal Investigator:

Mohamed S Naem

Digestive Disease Specialists, Inc.

Recruiting

Oklahoma City, Oklahoma, United States, 73114

Contacts

Principal Investigator:

David Stokesberry

Allegheny Health Network

Recruiting

Wexford, Pennsylvania, United States, 15090

Contacts

Principal Investigator:

Aakash Desai

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02094

Contacts

Principal Investigator:

Ferreira Jason

Sanford Health Research

Recruiting

Rapid City, South Dakota, United States, 57701

Contacts

Principal Investigator:

Blake Jones

Texas Digestive Disease Consultants Cedar Park

Recruiting

Cedar Park, Texas, United States, 78613

Contacts

Principal Investigator:

Junaid Siddiqui

GI Alliance - Digestive Health Associates of Texas

Recruiting

Dallas, Texas, United States, 75044

Contacts

Principal Investigator:

Harry E. Sarles

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Andrew Dupont

Texas Digestive Disease Consultants Lubbock

Recruiting

Lubbock, Texas, United States, 79410

Contacts

Principal Investigator:

Adam Hughston

GI Alliance - Mansfield

Recruiting

Mansfield, Texas, United States, 76063

Contacts

Principal Investigator:

Moustafa Youssef

Gastroenterology Research of San Antonio, LLC

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Nicholas Martinez

Southern Star Research Institute, LLC.

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Jeff Bullock

Texas Digestive Disease Consultants (TDDC), Southlake

Recruiting

Southlake, Texas, United States, 76092

Contacts

Principal Investigator:

Timothy Ritter

Tyler Research Institute, LLC

Recruiting

Tyler, Texas, United States, 75701

Contacts

Principal Investigator:

George Aaron DuVall

GI Alliance - Webster

Recruiting

Webster, Texas, United States, 77598

Contacts

Principal Investigator:

Nikhil Inamdar

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Principal Investigator:

John Valentine

Washington Gastroenterology- GIA

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Principal Investigator:

William Holderman

Covenant Health

Recruiting

Edmonton, Alberta, Canada, T5K 2K4

Contacts

Principal Investigator:

Jesse Siffledeen

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Principal Investigator:

Vipul Jairath

Viable Clinical Research - North Bay

Recruiting

North Bay, Ontario, Canada, P1B 2H3

Contacts

Principal Investigator:

Stephane Gauthier

Toronto Immune and Digestive Health Institute Inc. (TIDHI)

Recruiting

North York, Ontario, Canada, M6A3B4

Contacts

Principal Investigator:

Mark Silverberg

ABP Research Services Corp.

Recruiting

Oakville, Ontario, Canada, L6L 5L7

Contacts

Principal Investigator:

Bair Douglas

Toronto Digestive Disease Associates (TDDA) Inc.

Recruiting

Vaughan, Ontario, Canada, L4L 4Y7

Contacts

Principal Investigator:

Lee Roth

The Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Principal Investigator:

Talat Bessissow

More Information

Sponsor

Takeda

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Drug Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Takeda on 2026-08-31.