Not currently recruiting at UC Irvine

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Irvine, 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, 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 Gavin Herbert Eye Institute not yet accepting patients
    Irvine California 92697 United States
  • UCI Gottschalk Medical Plaza not yet accepting patients
    Irvine California 92697 United States
  • UCI Health Eye Care Services (Ophthalmoscopy and OCTs) not yet accepting patients
    Orange California 92868 United States
  • UCI Health H. H. Chao Comprehensive Digestive Disease Center not yet accepting patients
    Orange California 92868 United States
  • UCI Investigational Drug Services (IDSP - Pharmacy) not yet accepting patients
    Orange California 92868 United States
  • UCI Irvine Medical Center - Pulmonology Services - PFTs not yet accepting patients
    Orange California 92868 United States
  • Center for Clinical Research (CCR) not yet accepting patients
    Irvine California 92697 United States
  • CCR-ICTS Center for Innovative Patient Care not yet accepting patients
    Orange California 92697 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04607837
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 225 study participants
Last Updated