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An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | Clinical Trials | Clareo Health

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

An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

NCT03950232•Pfizer

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 \[NCT04607837\]).

Eligibility

Age

16 - 80 years

Sex

ALL

Healthy Volunteers

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

•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

Locations (469)

Center for Digestive Health (Colonoscopy Location)

Dothan, Alabama, United States

Pulmonary Associates (Secondary PFT Location)

Dothan, Alabama, United States

Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)

Dothan, Alabama, United States

Inland Pulmonary Specialists [PFT Only]

Lake Elsinore, California, United States

A V Pediatrics,Allergy and Family Medicine