Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT02536404
Last Updated: 2021-11-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2016-01-25
2018-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Etrasimod 2 mg
Etrasimod
Placebo
Placebo
Interventions
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Etrasimod
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Arena Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Arena CT.gov Administrator
Role: STUDY_DIRECTOR
Arena Pharmaceuticals
Locations
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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
Arena 1139
Hoffman Estates, Illinois, United States
Arena 1127
Urbana, Illinois, United States
Arena 1113
Chevy Chase, Maryland, United States
Arena 1142
Traverse City, Michigan, United States
Arena 1111
Troy, Michigan, United States
Arena 1109
Great Neck, New York, United States
Arena 1114
Rochester, New York, United States
Arena 1118
Raleigh, North Carolina, United States
Arena 1112
Cincinnati, Ohio, United States
Arena 1117
Pittsburgh, Pennsylvania, United States
Arena 1105
Germantown, Tennessee, United States
Arena 1102
Hermitage, Tennessee, United States
Arena 1136
DeSoto, Texas, United States
Arena 1121
Houston, Texas, United States
Arena 1116
Temple, Texas, United States
Arena 1103
Ogden, Utah, United States
Arena 1130
Richmond, Virginia, United States
Arena 1128
Roanoke, Virginia, United States
Arena 1115
Seattle, Washington, United States
Arena 1101
Seattle, Washington, United States
Arena 1108
Wauwatosa, Wisconsin, United States
Arena 1604
Kingswood, , Australia
Arena 1605
Randwick, , Australia
Arena 1607
Subiaco, , Australia
Arena 1490
Vienna, , Austria
Arena 1472
Edegem, , Belgium
Arena 1464
Kortrijk, , Belgium
Arena 1473
Leuven, , Belgium
Arena 1421
Rousse, , Bulgaria
Arena 1417
Sofia, , Bulgaria
Arena 1410
Sofia, , Bulgaria
Arena 1409
Sofia, , Bulgaria
Arena 1407
Sofia, , Bulgaria
Arena 1425
Varna, , Bulgaria
Arena 1202
Winnipeg, Manitoba, Canada
Arena 1210
Bridgewater, Nova Scotia, Canada
Arena 1208
Greater Sudbury, Ontario, Canada
Arena 1209
Greater Sudbury, Ontario, Canada
Arena 1206
London, Ontario, Canada
Arena 1204
Toronto, Ontario, Canada
Arena 1455
Prague, , Czechia
Arena 1443
Amiens, , France
Arena 1418
Clichy, , France
Arena 1437
Lille, , France
Arena 1476
Paris, , France
Arena 1480
Pierre-Bénite, , France
Arena 1423
Saint-Etienne, , France
Arena 1457
Vandœuvre-lès-Nancy, , France
Arena 1479
Hamburg, , Germany
Arena 1422
Hamburg, , Germany
Arena 1470
Hanover, , Germany
Arena 1446
Kiel, , Germany
Arena 1489
Leipzig, , Germany
Arena 1497
Oldenburg, , Germany
Arena 1444
Ulm, , Germany
Arena 1478
Békéscsaba, , Hungary
Arena 1431
Budapest, , Hungary
Arena 1471
Budapest, , Hungary
Arena 1492
Budapest, , Hungary
Arena 1505
Debrecen, , Hungary
Arena 1474
Debrecen, , Hungary
Arena 1477
Szombathely, , Hungary
Arena 1705
Beersheba, , Israel
Arena 1702
Haifa, , Israel
Arena 1706
Holon, , Israel
Arena 1704
Jerusalem, , Israel
Arena 1703
Petah Tikva, , Israel
Arena 1462
Riga, , Latvia
Arena 1475
Riga, , Latvia
Arena 1484
Vilnius, , Lithuania
Arena 1601
Christchurch, , New Zealand
Arena 1439
Bydgoszcz, , Poland
Arena 1486
Elblag, , Poland
Arena 1495
Kielce, , Poland
Arena 1451
Krakow, , Poland
Arena 1438
Lodz, , Poland
Arena 1458
Poznan, , Poland
Arena 1428
Rzeszów, , Poland
Arena 1456
Sopot, , Poland
Arena 1494
Wroclaw, , Poland
Arena 1491
Bucharest, , Romania
Arena 1406
Bucharest, , Romania
Arena 1441
Bucharest, , Romania
Arena 1436
Iași, , Romania
Arena 1420
Oradea, , Romania
Arena 1405
Timișoara, , Romania
Arena 1493
Timișoara, , Romania
Arena 1500
Krasnoyarsk, , Russia
Arena 1504
Novosibirsk, , Russia
Arena 1419
Rostov-on-Don, , Russia
Arena 1498
Saint Petersburg, , Russia
Arena 1448
Saint Petersburg, , Russia
Arena 1465
Samara, , Russia
Arena 1615
Wŏnju, Gangwon-do, South Korea
Arena 1614
Daegu, , South Korea
Arena 1610
Incheon, , South Korea
Arena 1403
Barcelona, , Spain
Arena 1460
Barcelona, , Spain
Arena 1481
Madrid, , Spain
Arena 1430
Pontevedra, , Spain
Arena 1432
Santiago de Compostela, , Spain
Arena 1469
Seville, , Spain
Arena 1424
Chernivtsi, , Ukraine
Arena 1445
Ivano-Frankivsk, , Ukraine
Arena 1454
Kharkiv, , Ukraine
Arena 1459
Kharkiv, , Ukraine
Arena 1466
Kiev, , Ukraine
Arena 1411
Kiev, , Ukraine
Arena 1408
Kyiv, , Ukraine
Arena 1506
Kyiv, , Ukraine
Arena 1414
Odesa, , Ukraine
Arena 1433
Uzhhorod, , Ukraine
Arena 1416
Vinnytsia, , Ukraine
Arena 1501
Vinnytsia, , Ukraine
Arena 1302
London, , United Kingdom
Arena 1304
Torquay, , United Kingdom
Arena 1303
Wolverhampton, , United Kingdom
Countries
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References
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Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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APD334-005
Identifier Type: -
Identifier Source: org_study_id