Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT02536404
- Lead Sponsor
- Arena Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- Participants who completed the APD334-003 (NCT02447302) study
- Participants who did not complete the APD334-003 study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Etrasimod 2 mg Etrasimod -
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
- Secondary Outcome Measures
Name Time Method Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005 Week 12 (core study APD334-003) and Week 46 (extension study APD334-005) A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Proportion of Participants Who Achieved Clinical Response Week 46 (extension study APD334-005) A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Proportion of Participants Who Achieved Clinical Remission Week 46 (extension study APD334-005) A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005 Week 12 (core study APD334-003) and Week 46 (extension study APD334-005) A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Trial Locations
- Locations (127)
Arena 1119
🇺🇸Birmingham, Alabama, United States
Arena 1133
🇺🇸Dothan, Alabama, United States
Arena 1143
🇺🇸Thousand Oaks, California, United States
Arena 1107
🇺🇸Hollywood, Florida, United States
Arena 1138
🇺🇸Miami, Florida, United States
Arena 1123
🇺🇸Naples, Florida, United States
Arena 1141
🇺🇸Orlando, Florida, United States
Arena 1106
🇺🇸Port Orange, Florida, United States
Arena 1137
🇺🇸Sweetwater, Florida, United States
Arena 1131
🇺🇸Chicago, Illinois, United States
Scroll for more (117 remaining)Arena 1119🇺🇸Birmingham, Alabama, United States