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
Sponsor organisation
Arena Pharmaceuticals Inc.
Eudract number
2018-003986-33
Clinicaltrials.gov Identifier
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 ColitisIntervention:
Active drug: etrasimod (oral tablet)
Etrasimod: once daily, for 12 weeks.
Placebo comparator: Placebo (oral tablet)
Matching placebo: once dailyKey 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-versusREC 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