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    Digestive Health Clinical Trials

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

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    What is the purpose of this 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.

    Eligibility

    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.

    Where can I participate?

    Hoag Hospital Irvine
    16200 Sand Canyon Ave
    Irvine, CA 92618


    Vianh Truong

    vianh.truong@hoag.org


    Hoag Hospital Newport Beach
    1 Hoag
    Newport Beach, CA 92663


    Vianh Truong

    vianh.truong@hoag.org


    More about this Clinical Trial

    What is the full name of this Clinical Trial?

    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)

    • Disease Type/ConditionCrohn's Disease
    • Principal InvestigatorCaroline Hwang, MD
    • Co-InvestigatorsMonica McCawley, NP, Rashmi Kumar, MD
    • Age GroupAdult, Older Adult
    • PhaseIV
    • ClinicalTrials.gov IDNCT06045754

    Hoag Digestive Health Institute

    Hoag Digestive Health Institute provides advanced, comprehensive care for the full spectrum of digestive conditions, with access to world-class specialists, diagnostics and imaging, advanced interventional therapeutics, and clinical trials. Patients benefit from a research-driven approach that connects leading-edge treatment options with personalized care across gastroenterology and GI surgery.

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