APD334-302 - ELEVATE UC 12: Etrasimod v Placebo as Induction Therapy

  • Research type

    Research Study

  • Full title

    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

  • IRAS ID

    266984

  • Contact name

    Peter Irving

  • Contact email

    Peter.Irving@gstt.nhs.uk

  • Sponsor organisation

    Arena Pharmaceuticals Inc.

  • Eudract number

    2018-003986-33

  • Clinicaltrials.gov Identifier

    NCT03996369

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Summary of Research

    This study evaluates the effectiveness and safety of etrasimod in subjects with ulcerative colitis (UC) with moderately to severely active ulcerative colitis. Each subject will be enrolled in the study for approximately 18 weeks, including 28 days of screening (medical tests and results review to assess suitability), 12 weeks of treatment (induction), and 2 weeks of follow-up. Subjects will be randomly selected (like flipping a coin) to receive either once daily etrasimod (active drug) or placebo (control without drug). Neither the subject nor the research team know which treatment the subject is receiving.

    The primary objective is to assess the potential effectiveness of etrasimod on clinical remission in subjects with moderately to severely active ulcerative colitis after 12 weeks of treatment.

    The study will be conducted in approximately 330 participants worldwide.

    Health Status, examined disease:
    Ulcerative Colitis

    Intervention:
    Active drug: etrasimod (oral tablet)
    Etrasimod: once daily, for 12 weeks.
    Placebo comparator: Placebo (oral tablet)
    Matching placebo: once daily

    Key Inclusion and Exclusion criteria:
    Inclusion:
    • Males, females and adolescents aged 16-80 years.
    • Diagnosed with UC equal or more than 3 months prior to screening
    • Active UC confirmed by endoscopy and histology
    Exclusion:
    • Severe extensive colitis.
    • Diagnosis of Crohn’s Disease.
    • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis.

    Summary of Results

    Clinical Study Results are present at-
    https://www.pfizer.com/science/clinical-trials/plain-language-study-results-summaries/elevate-uc-12-etrasimod-versus

  • REC name

    East of England - Essex Research Ethics Committee

  • REC reference

    19/EE/0334

  • Date of REC Opinion

    24 Feb 2020

  • REC opinion

    Further Information Favourable Opinion