For Healthcare Professionals

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

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About the study

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]).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:


  1. 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
  2. Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit

EXCLUSION CRITERIA

Exclusion Criteria:


  1. If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
  2. Experienced an adverse event that led to discontinuation from parent study

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Ulcerative Colitis

Age (in years)

16 - 80

Phase

Phase 3

Participants needed

912

Est. Completion Date

Jan 31, 2027

Treatment type

Interventional


Sponsor

Pfizer

ClinicalTrials.gov identifier

NCT03950232

Study number

APD334-303

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