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 1142
🇺🇸Traverse City, Michigan, United States
Arena 1433
🇺🇦Uzhgorod, Ukraine
Arena 1115
🇺🇸Seattle, Washington, United States
Arena 1101
🇺🇸Seattle, Washington, United States
Arena 1112
🇺🇸Cincinnati, Ohio, United States
Arena 1474
🇭🇺Debrecen, Hungary
Arena 1431
🇭🇺Budapest, Hungary
Arena 1421
🇧🇬Ruse, Bulgaria
Arena 1410
🇧🇬Sofia, Bulgaria
Arena 1436
🇷🇴Iasi, Romania
Arena 1493
🇷🇴Timisoara, Romania
Arena 1492
🇭🇺Budapest, Hungary
Arena 1462
🇱🇻Riga, Latvia
Arena 1451
🇵🇱Krakow, Poland
Arena 1490
🇦🇹Wien, Austria
Arena 1484
🇱🇹Vilnius, Lithuania
Arena 1491
🇷🇴Bucharest, Romania
Arena 1441
🇷🇴Bucharest, Romania
Arena 1407
🇧🇬Sofia, Bulgaria
Arena 1478
🇭🇺Bekescsaba, Hungary
Arena 1505
🇭🇺Debrecen, Hungary
Arena 1494
🇵🇱Wroclaw, Poland
Arena 1420
🇷🇴Oradea, Romania
Arena 1471
🇭🇺Budapest, Hungary
Arena 1476
🇫🇷Paris, France
Arena 1423
🇫🇷Saint-Etienne Cedex 1, France
Arena 1457
🇫🇷Vandoeuvre-les-Nancy, France
Arena 1204
🇨🇦Toronto, Ontario, Canada
Arena 1209
🇨🇦Sudbury, Ontario, Canada
Arena 1121
🇺🇸Houston, Texas, United States
Arena 1123
🇺🇸Naples, Florida, United States
Arena 1139
🇺🇸Hoffman Estates, Illinois, United States
Arena 1425
🇧🇬Varna, Bulgaria
Arena 1131
🇺🇸Chicago, Illinois, United States
Arena 1138
🇺🇸Miami, Florida, United States
Arena 1141
🇺🇸Orlando, Florida, United States
Arena 1137
🇺🇸Sweetwater, Florida, United States
Arena 1113
🇺🇸Chevy Chase, Maryland, United States
Arena 1106
🇺🇸Port Orange, Florida, United States
Arena 1105
🇺🇸Germantown, Tennessee, United States
Arena 1116
🇺🇸Temple, Texas, United States
Arena 1103
🇺🇸Ogden, Utah, United States
Arena 1604
🇦🇺Kingswood, Australia
Arena 1605
🇦🇺Randwick, Australia
Arena 1128
🇺🇸Roanoke, Virginia, United States
Arena 1607
🇦🇺Subiaco, Australia
Arena 1417
🇧🇬Sofia, Bulgaria
Arena 1202
🇨🇦Winnipeg, Manitoba, Canada
Arena 1409
🇧🇬Sofia, Bulgaria
Arena 1443
🇫🇷Amiens Cedex 1, France
Arena 1706
🇮🇱Holon, Israel
Arena 1475
🇱🇻Riga, Latvia
Arena 1424
🇺🇦Chernivtsi, Ukraine
Arena 1430
🇪🇸Pontevedra, Spain
Arena 1408
🇺🇦Kyiv, Ukraine
Arena 1403
🇪🇸Barcelona, Spain
Arena 1119
🇺🇸Birmingham, Alabama, United States
Arena 1703
🇮🇱Petah-Tikva, Israel
Arena 1704
🇮🇱Jerusalem, Israel
Arena 1114
🇺🇸Rochester, New York, United States
Arena 1133
🇺🇸Dothan, Alabama, United States
Arena 1143
🇺🇸Thousand Oaks, California, United States
Arena 1107
🇺🇸Hollywood, Florida, United States
Arena 1127
🇺🇸Urbana, Illinois, United States
Arena 1109
🇺🇸Great Neck, New York, United States
Arena 1111
🇺🇸Troy, Michigan, United States
Arena 1117
🇺🇸Pittsburgh, Pennsylvania, United States
Arena 1102
🇺🇸Hermitage, Tennessee, United States
Arena 1136
🇺🇸DeSoto, Texas, United States
Arena 1130
🇺🇸Richmond, Virginia, United States
Arena 1480
🇫🇷Pierre-Benite, France
Arena 1210
🇨🇦Bridgewater, Nova Scotia, Canada
Arena 1206
🇨🇦London, Ontario, Canada
Arena 1208
🇨🇦Sudbury, Ontario, Canada
Arena 1455
🇨🇿Praha 4, Czechia
Arena 1418
🇫🇷Clichy, France
Arena 1437
🇫🇷Lille Cedex 1443, France
Arena 1422
🇩🇪Hamburg, Germany
Arena 1446
🇩🇪Kiel, Germany
Arena 1470
🇩🇪Hanover, Germany
Arena 1479
🇩🇪Hamburg, Germany
Arena 1497
🇩🇪Oldenburg, Germany
Arena 1444
🇩🇪Ulm, Germany
Arena 1477
🇭🇺Szombathely, Hungary
Arena 1705
🇮🇱Beer Sheva, Israel
Arena 1702
🇮🇱Haifa, Israel
Arena 1615
🇰🇷Wonju, Gangwon-do, Korea, Republic of
Arena 1614
🇰🇷Daegu, Korea, Republic of
Arena 1610
🇰🇷Incheon, Korea, Republic of
Arena 1439
🇵🇱Bydgoszcz, Poland
Arena 1438
🇵🇱Lodz, Poland
Arena 1601
🇳🇿Christchurch, New Zealand
Arena 1486
🇵🇱Elblag, Poland
Arena 1495
🇵🇱Kielce, Poland
Arena 1428
🇵🇱Rzeszow, Poland
Arena 1458
🇵🇱Poznań, Poland
Arena 1456
🇵🇱Sopot, Poland
Arena 1406
🇷🇴Bucharest, Romania
Arena 1500
🇷🇺Krasnoyarsk, Russian Federation
Arena 1405
🇷🇴Timisoara, Romania
Arena 1419
🇷🇺Rostov-on-Don, Russian Federation
Arena 1504
🇷🇺Novosibirsk, Russian Federation
Arena 1448
🇷🇺Saint Petersburg, Russian Federation
Arena 1498
🇷🇺Saint Petersburg, Russian Federation
Arena 1465
🇷🇺Samara, Russian Federation
Arena 1460
🇪🇸Barcelona, Spain
Arena 1432
🇪🇸Santiago de Compostela, Spain
Arena 1481
🇪🇸Madrid, Spain
Arena 1469
🇪🇸Sevilla, Spain
Arena 1445
🇺🇦Ivano-Frankivsk, Ukraine
Arena 1454
🇺🇦Kharkov, Ukraine
Arena 1466
🇺🇦Kiev, Ukraine
Arena 1459
🇺🇦Kharkov, Ukraine
Arena 1506
🇺🇦Kyiv, Ukraine
Arena 1414
🇺🇦Odessa, Ukraine
Arena 1302
🇬🇧London, United Kingdom
Arena 1303
🇬🇧Wolverhampton, United Kingdom
Arena 1304
🇬🇧Torquay, United Kingdom
Arena 1489
🇩🇪Leipzig, Germany
Arena 1118
🇺🇸Raleigh, North Carolina, United States
Arena 1472
🇧🇪Edegem, Belgium
Arena 1501
🇺🇦Vinnytsia, Ukraine
Arena 1416
🇺🇦Vinnytsya, Ukraine
Arena 1464
🇧🇪Kortrijk, Belgium
Arena 1473
🇧🇪Leuven, Belgium
Arena 1411
🇺🇦Kiev, Ukraine
Arena 1108
🇺🇸Wauwatosa, Wisconsin, United States