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Double-Drug attack on Crohn's: could two biologics be better than one?

NCT ID NCT06045754

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 9 times

Summary

This study is testing whether combining two different biologic drugs can better control moderate to severe Crohn's disease. One hundred adults will first receive either vedolizumab plus adalimumab or vedolizumab plus ustekinumab. Those who respond well will then switch to vedolizumab alone. The goal is to see if the combination improves bowel healing and symptoms, and if the benefit can be maintained with a single drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vedolizumab (Entyvio), adalimumab (Humira), ustekinumab (Stelara)
What this could lead to
If successful, this could show that combining two targeted therapies is safe and effective for controlling moderate to severe Crohn's disease, and that some patients may then maintain control with just one drug.
What could go wrong
This is a small, early-phase 4 study with only 100 participants, so results may not apply to everyone. Combining two powerful immune-suppressing drugs also raises the risk of serious infections and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    48 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ABP Research Services Corp.

    RECRUITING

    Oakville, Ontario, L6L 5L7, Canada

  • Allegheny Health Network

    RECRUITING

    Wexford, Pennsylvania, 15090, United States

  • Alliance Clinical Research of Tampa, LLC

    RECRUITING

    Tampa, Florida, 33615, United States

  • BVL Clinical Research

    RECRUITING

    Liberty, Missouri, 64068, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Clinical Research of Osceola

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Cotton ONeil Clinical Research Center

    RECRUITING

    Topeka, Kansas, 66606, United States

  • Covenant Health

    RECRUITING

    Edmonton, Alberta, T5K 2K4, Canada

  • Digestive Disease Specialists, Inc.

    RECRUITING

    Oklahoma City, Oklahoma, 73114, United States

  • Digestive Health Specialsits

    RECRUITING

    Dothan, Alabama, 36301, United States

  • Endoscopic Research Inc

    RECRUITING

    Orlando, Florida, 32803, United States

  • GI Alliance

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • GI Alliance - Digestive Health Associates of Texas

    RECRUITING

    Dallas, Texas, 75044, United States

  • GI Alliance - Mansfield

    RECRUITING

    Mansfield, Texas, 76063, United States

  • GI Alliance - Webster

    RECRUITING

    Webster, Texas, 77598, United States

  • GI Alliance Sun City

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Gastro Intestinal Research Institute of Northern Ohio, LLC.

    RECRUITING

    Westlake, Ohio, 44145, United States

  • Gastroenterology Consultants, P.C.

    RECRUITING

    Roswell, Georgia, 30076, United States

  • Gastroenterology Research of San Antonio, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Great Lakes Gastroenterology Research, LLC

    RECRUITING

    Mentor, Ohio, 44060, United States

  • Hoag Hospital Newport Beach

    RECRUITING

    Newport Beach, California, 92663, United States

  • Huron Gastroenterology Associates, P.C.

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Medical Research Center of Connecticut, LLC

    RECRUITING

    Hamden, Connecticut, 06518, United States

  • Mid-America Gastro-Intestinal Consultants

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Ohio Gastroenterology group, Inc.

    RECRUITING

    Columbus, Ohio, 43202, United States

    Contact Email: •••••@•••••

  • Sanford Health Research

    RECRUITING

    Rapid City, South Dakota, 57701, United States

  • Southern Star Research Institute, LLC.

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Texas Digestive Disease Consultants (TDDC), Southlake

    RECRUITING

    Southlake, Texas, 76092, United States

  • Texas Digestive Disease Consultants Cedar Park

    RECRUITING

    Cedar Park, Texas, 78613, United States

  • Texas Digestive Disease Consultants Lubbock

    RECRUITING

    Lubbock, Texas, 79410, United States

  • The Research Institute of the McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Toronto Digestive Disease Associates (TDDA) Inc.

    RECRUITING

    Vaughan, Ontario, L4L 4Y7, Canada

  • Toronto Immune and Digestive Health Institute Inc. (TIDHI)

    RECRUITING

    North York, Ontario, M6A3B4, Canada

  • Tulane University

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Tyler Research Institute, LLC

    RECRUITING

    Tyler, Texas, 75701, United States

  • University Gastroenterology

    RECRUITING

    Providence, Rhode Island, 02094, United States

  • University of California San Diego Health (UCSD)

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Chicago Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45627, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Viable Clinical Research - North Bay

    RECRUITING

    North Bay, Ontario, P1B 2H3, Canada

  • Washington Gastroenterology- GIA

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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