Etrasimod for Ulcerative Colitis
(ELEVATE UC OLE Trial)

Recruiting in Palo Alto (17 mi)

+891 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \[NCT03945188\] or APD334-302 \[NCT03996369\] or APD334-210 \[NCT04607837\]).

Eligibility Criteria

This trial is for people with moderate to severe ulcerative colitis who were in previous phase 2 or 3 trials of etrasimod. They must have finished at least 12 weeks of the prior study and still have active symptoms, or their condition must not have improved or worsened.

Inclusion Criteria

People who were previously enrolled in the study called APD334-302 must have finished their visit at Week 12.

I was in a previous study and either my UC didn't improve by Week 12 or I completed Week 52.

Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies and meet the following additional criteria:

Exclusion Criteria

Experienced an adverse event that led to discontinuation from parent study

If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study

Treatment Details

Interventions

Etrasimod (Sphingosine-1-Phosphate Receptor Modulator)

Trial OverviewThe trial tests the long-term safety and effectiveness of etrasimod, a medication for ulcerative colitis. Participants will receive etrasimod openly, meaning they'll know they're getting the actual drug, not a placebo.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Etrasimod 2 mgExperimental Treatment1 Intervention