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A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects with Moderately to Severely Active Ulcerative Colitis

  • Clinical Trial Information

    Trial Contact: Tilme, Linda; Beltran, Yajira

    Trial Phone: 321.843.5278 ; 321.841.7619

  • IRB No: 22.106.05

    Protocol Abbrev: APD 334-207

    Principal Investigator: Jeffrey A. Bornstein, MD

    Phase: Drug: Phase II

    Age Group: Pediatric

    Secondary Protocol No: APD334-207

    Treatment: Drug: Etrasimod

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT05287126

  • Objective

    Primary objective: The primary objective is to assess the efficacy of etrasimod on clinical remission in adolescents
    (≥ 12 years up to < 18 years of age) with moderately to severely active ulcerative colitis (UC) after
    52 weeks of treatment.

    Secondary objectives: The secondary objectives are to evaluate the pharmacokinetics (PK) of etrasimod after daily doses for up to 52 weeks in adolescents and to assess the efficacy of etrasimod on clinical remission, endoscopic
    changes, symptomatic remission, corticosteroid-free remission, and clinical response in adolescents
    with moderately to severely active UC at timepoints up to 52 weeks of treatment.

    Safety objective: The safety objective is to assess the safety of etrasimod after daily doses in adolescents with
    moderately to severely active UC.

    Other objectives: Other objectives include evaluation of the effect of etrasimod on health-related subject-reported outcomes and biomarkers.

  • Key Eligibility

    ≥ 12 years up to < 18 years of age diagnosed with UC ≥ 4 weeks prior to screening. Moderately to severely active UC defined as MMS of 5 to 9, including an ES score ≥ 2 and RB score ≥ 1.