An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT03950232
- Lead Sponsor
- Pfizer
- Brief 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 \[NCT04607837\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 778
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Etrasimod 2 mg Etrasimod -
- Primary Outcome Measures
Name Time Method Number and Severity of Safety Measures Up to approximately 8 years Safety as assessed by the evaluation of adverse events
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores Week 52 and Week 104 Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores Week 52 and Week 104 Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores Week 52 and Week 104 Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry Week 52 and Week 104 Change From Baseline in Partial Mayo Score Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260 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.
Change From Baseline in the Total Mayo Score Baseline, Week 52, and Week 104 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.
Trial Locations
- Locations (669)
AZ Delta Roeselare VZW Campus
🇧🇪Roeselare, Belgium
CHU Nantes - Hôtel Dieu
🇫🇷Nantes, France
Krankenhaus Waldfriede e.V.,
🇩🇪Berlin, Germany
Fejer Vármegyei Szent Gyorgy Egyetemi Oktato Korhaz
🇭🇺Szekesfehervar, Fejer, Hungary
Gyöngyösi Bugát Pál Kórház
🇭🇺Gyöngyös, Hungary
Ospedale di Circolo
🇮🇹Rho, Milan, Italy
Memorial Healthcare International SRL
🇷🇴Bucharest, Romania
Center for Digestive Health (Colonoscopy Location)
🇺🇸Dothan, Alabama, United States
Digestive Health Specialists (IP Address)
🇺🇸Dothan, Alabama, United States
Dothan Eyecare-Dr. Brent McKinley (OCT Location)
🇺🇸Dothan, Alabama, United States
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