APD334-301 - ELEVATE UC 52: Etrasimod v Placebo for Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

• IRAS ID

  266983

• Contact name

  Peter Irving

• Contact email

  Peter.Irving@gstt.nhs.uk

• Sponsor organisation

  Arena Pharmaceuticals Inc.

• Eudract number

  2018-003985-15

• Clinicaltrials.gov Identifier

  NCT03945188

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 3 months, 11 days

• Research summary

  Summary of Research

  This study evaluates the effectiveness and safety of etrasimod in subjects with ulcerative colitis (UC). Each subject will be enrolled in the study for up to 52 weeks, including 28 days of screening (medical tests and results review to assess suitability), 12 weeks of treatment (induction), followed by 40 weeks of treatment (maintenance), 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 and 52 weeks of treatment.

  The study will be conducted in approximately 370 participants worldwide.

  Health Status, examined disease:
  Ulcerative Colitis

  Intervention:
  Active drug: etrasimod (oral tablet)
  Etrasimod: once daily, for up to 52 weeks.
  Placebo comparator: Placebo (oral tablet)
  Matching placebo: once daily

  Key Inclusion and Exclusion criteria:
  Inclusion:
  • Males or females 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 Result is available at-
  https://www.pfizer.com/science/clinical-trials/plain-language-study-results-summaries/elevate-uc-52-etrasimod-versus

• REC name

  Wales REC 1

• REC reference

  19/WA/0222

• Date of REC Opinion

  2 Sep 2019

• REC opinion

  Further Information Favourable Opinion