Active — Not RecruitingPhase 3

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

United States896 participantsStarted 2019-09-05

Plain-language summary

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 \[NCT04607837\]).

Who can participate

Age range16 Years – 80 Years

SexALL

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Inclusion criteria

✓. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
✓. Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit

What they're measuring

Number and Severity of Safety Measures

Timeframe: Up to approximately 8 years

Trial details

NCT IDNCT03950232

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-19

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