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Treatment options for adults with Crohn's Disease using vedolizumab and other medications

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)

Phase 4 Interventional Takeda · NCT06045754

This study is testing if combining vedolizumab with either adalimumab or ustekinumab can help adults with moderate to severe Crohn's Disease feel better and stay healthy.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsvedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab, rituximab, adalimumab, ustekinumab
Locations54 sites (Dothan, Alabama and 53 other locations)
Trial IDNCT06045754 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of vedolizumab intravenous (IV) combined with either adalimumab or ustekinumab in adults suffering from moderate to severe Crohn's Disease. It consists of two parts: the first part involves dual targeted therapy, while the second part focuses on the efficacy of vedolizumab alone for those who respond to the initial treatment. Participants will be monitored for at least 26 weeks following their last dose to assess the long-term safety and effectiveness of the treatments. The study aims to enroll approximately 150 patients across multiple centers in the United States and Canada.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of Crohn's Disease who have experienced inadequate response, loss of response, or intolerance to prior treatments.

Not a fit: Patients who have primary nonresponse to two or more agents or those with mild Crohn's Disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for patients with Crohn's Disease who have not responded adequately to existing therapies.

How similar studies have performed: Other studies have shown promise with similar dual-targeted therapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Dothan, Alabama and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseDrug Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.