Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Orange, 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 ≥ 2 and rectal bleeding 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

  • UCI Health H.H. Chao Comprehensive Digestive Disease Center accepting new patients
    Orange California 92868 United States
  • United Medical Doctors accepting new patients
    Murrieta California 92563 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arena Pharmaceuticals
ID
NCT04607837
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 225 study participants
Last Updated