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 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, 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

  • UCSD Clinical and Translational Research Institute (Research Clinic) accepting new patients
    La Jolla California 92037 United States
  • UCSD Health System (PFT/Endoscopy) accepting new patients
    La Jolla California 92037 United States
  • UCSD lnvestigational Drug Service Pharmacy accepting new patients
    La Jolla California 92037 United States
  • Koman Family Outpatient Pavilion (Endoscopy) accepting new patients
    La Jolla California 92037 United States
  • Perlman Medical Offices (IBD Clinic) accepting new patients
    La Jolla California 92037 United States
  • Shiley Eye Institute (OCT) accepting new patients
    La Jolla California 92093 United States
  • ACRC Studies terminated
    San Diego California 92119 United States
  • Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only) terminated
    La Mesa California 91942 United States
  • Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only) terminated
    La Mesa California 91942 United States
  • Euclid Endoscopy Center-El Cajon (Endoscopy procedure only) terminated
    El Cajon California 92020 United States

Details

Status
accepting new patients
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
Contact us about this trial