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

Details

Status
in progress, not 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
About 235 people participating
Last Updated