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A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

  • Clinical Trial Information

    Trial Contact: Garcia de Djuro, Ginette; Britton, David ; Shepherd, Adriane R

  • IRB No: W.22.076.03

    Protocol Abbrev: CULTIVATE

    Principal Investigator: Udayakumar Navaneethan, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: APD334-202

    Treatment: Oral etrasimod (APD334)

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT04173273

  • Objective

    Primary Objectives
    Substudy A is complete.
    Substudy 1 – Phase 2b
    •   To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction
    therapy in subjects with moderately to severely active CD
    •   To select an oral etrasimod dose(s), based on efficacy and safety, for continued development
    Substudy 2 – Induction (Phase 3)
    •   To evaluate the efficacy of the selected etrasimod dose versus placebo as induction therapy in
    subjects with moderately to severely active CD
    Substudy 3 – Maintenance (Phase 3)
    •   To evaluate the efficacy of etrasimod versus placebo as maintenance therapy in subjects with
    moderately to severely active CD
    Substudy 4 – Long-Term Extension
    •   To evaluate the long-term safety and tolerability of etrasimod in subjects with moderately to
    severely active CD

  • Key Eligibility

    Have CD for ≥ 3 months prior to randomization, involving the ileum and/or colon, at a minimum; diagnosis may be confirmed at any time in the past by endoscopy and/or histopathology. The screening endoscopy and histopathology reports may serve as source documents for subjects who do not have diagnostic endoscopy reports in their medical chart.
    Have moderately to severely active CD at Screening.