Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, Etrasimod, APD334
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 \[NCT04607837\]).
Interventions
DRUGEtrasimod
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
Sponsors
Pfizer
Arena is a wholly owned subsidiary of Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Severity of Safety Measures | Up to approximately 8 years | Safety as assessed by the evaluation of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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 | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Mexico, Moldova, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed