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

Phase 3Active Not RecruitingNCT03950232

Pfizer896 enrolled

Overview

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 \[NCT04607837\]).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

896

Conditions

Ulcerative Colitis

Interventions

EtrasimodDRUG

Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (470)

Outcomes

Primary Outcomes

Number and Severity of Safety Measures

Safety as assessed by the evaluation of adverse events

Time frame: Up to approximately 8 years

Secondary Outcomes

Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores

Time frame: Week 52 and Week 104

Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry

Time frame: Week 52 and Week 104

Change From Baseline in the Total Mayo Score

The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.

Time frame: Baseline, Week 52, and Week 104

Change From Baseline in Partial Mayo Score

The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.

Time frame: Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260

Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores

Time frame: Week 52 and Week 104

Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores

Data from ClinicalTrials.gov

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Center for Digestive Health (Colonoscopy Location)