Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

Official Title

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

Keywords

Ulcerative Colitis Etrasimod APD334 UC Colitis Colitis, Ulcerative Ulcer Etrasimod 2 mg

Eligibility

You can join if…

Open to people ages 18-80

  • Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
  • Active UC confirmed by endoscopy
  • Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 1
  • Received a surveillance colonoscopy within 12 months before baseline

You CAN'T join if...

  • Severe extensive colitis
  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
  • Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening

Locations

  • UCSD Clinical and Translational Research Institute accepting new patients
    La Jolla California 92037 United States
  • ACRC Studies accepting new patients
    San Diego California 92119 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arena Pharmaceuticals
Links
Related Info
ID
NCT04607837
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 162 study participants
Last Updated