An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
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]).
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:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
- Experienced an adverse event that led to discontinuation from parent study
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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