Clinical trial NCT02447302: Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
* Evidence of colonic ulcerative colitis activity on endoscopy

Exclusion Criteria:

* Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
* Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
* Any prior exposure to natalizumab, efalizumab, or rituximab

Primary outcomes:
measure: Change From Baseline in Adapted Mayo Score (MCS) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
timeFrame: Week 12
measure: Change From Baseline in 2-component MCS at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Total Mayo Score (TMS) at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
measure: Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved Clinical Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved Clinical Response at Week 12
timeFrame: Week 12
Locations:
city: Birmingham
country: United States
facility: Arena 1119
state: Alabama
city: Dothan
country: United States
facility: Arena 1133
state: Alabama
city: Thousand Oaks
country: United States
facility: Arena 1143
state: California
city: Hollywood
country: United States
facility: Arena 1107
state: Florida
city: Miami
country: United States
facility: Arena 1138
state: Florida
city: Naples
country: United States
facility: Arena 1123
state: Florida
city: Orlando
country: United States
facility: Arena 1141
state: Florida
city: Port Orange
country: United States
facility: Arena 1106
state: Florida
city: Sweetwater
country: United States
facility: Arena 1137
state: Florida
city: Chicago
country: United States
facility: Arena 1131
state: Illinois
city: Hoffman Estates
country: United States
facility: Arena 1139
state: Illinois
city: Urbana
country: United States
facility: Arena 1127
state: Illinois
city: Traverse City
country: United States
facility: Arena 1142
state: Michigan
city: Troy
country: United States
facility: Arena 1111
state: Michigan
city: Great Neck
country: United States
facility: Arena 1109
state: New York
city: Rochester
country: United States
facility: Arena 1114
state: New York
city: Raleigh
country: United States
facility: Arena 1118
state: North Carolina
city: Cincinnati
country: United States
facility: Arena 1112
state: Ohio
city: Pittsburgh
country: United States
facility: Arena 1117
state: Pennsylvania
city: Germantown
country: United States
facility: Arena 1105
state: Tennessee
city: Hermitage
country: United States
facility: Arena 1102
state: Tennessee
city: DeSoto
country: United States
facility: Arena 1136
state: Texas
city: Houston
country: United States
facility: Arena 1121
state: Texas
city: Temple
country: United States
facility: Arena 1116
state: Texas
city: Ogden
country: United States
facility: Arena 1103
state: Utah
city: Richmond
country: United States
facility: Arena 1130
state: Virginia
city: Roanoke
country: United States
facility: Arena 1128
state: Virginia
city: Seattle
country: United States
facility: Arena 1115
state: Washington
city: Seattle
country: United States
facility: Arena 1101
state: Washington
city: Wauwatosa
country: United States
facility: Arena 1108
state: Wisconsin
city: Kingswood
country: Australia
facility: Arena 1604
city: Randwick
country: Australia
facility: Arena 1605
city: Subiaco
country: Australia
facility: Arena 1607
city: Wien
country: Austria
facility: Arena 1490
city: Edegem
country: Belgium
facility: Arena 1472
city: Kortrijk
country: Belgium
facility: Arena 1464
city: Löwen
country: Belgium
facility: Arena 1473
city: Ruse
country: Bulgaria
facility: Arena 1421
city: Sofia
country: Bulgaria
facility: Arena 1409
city: Sofia
country: Bulgaria
facility: Arena 1410
city: Sofia
country: Bulgaria
facility: Arena 1417
city: Sofia
country: Bulgaria
facility: Arena 1407
city: Varna
country: Bulgaria
facility: Arena 1425
city: Winnipeg
country: Canada
facility: Arena 1202
state: Manitoba
city: Bridgewater
country: Canada
facility: Arena 1210
state: Nova Scotia
city: London
country: Canada
facility: Arena 1206
state: Ontario
city: Sudbury
country: Canada
facility: Arena 1208
state: Ontario
city: Sudbury
country: Canada
facility: Arena 1209
state: Ontario
city: Toronto
country: Canada
facility: Arena 1204
state: Ontario
city: Praha 4
country: Czechia
facility: Arena 1455
city: Amiens Cedex 1
country: France
facility: Arena 1443
city: Clichy
country: France
facility: Arena 1418
city: Lille Cedex 1443
country: France
facility: Arena 1437
city: Paris
country: France
facility: Arena 1476
city: Pierre-Benite
country: France
facility: Arena 1480
city: Saint-Etienne Cedex 1
country: France
facility: Arena 1423
city: Vandoeuvre-les-Nancy
country: France
facility: Arena 1457
city: Hamburg
country: Germany
facility: Arena 1479
city: Hamburg
country: Germany
facility: Arena 1422
city: Hanover
country: Germany
facility: Arena 1470
city: Kiel
country: Germany
facility: Arena 1446
city: Leipzig
country: Germany
facility: Arena 1489
city: Oldenburg
country: Germany
facility: Arena 1497
city: Ulm
country: Germany
facility: Arena 1444
city: Bekescsaba
country: Hungary
facility: Arena 1478
city: Budapest
country: Hungary
facility: Arena 1471
city: Budapest
country: Hungary
facility: Arena 1492
city: Budapest
country: Hungary
facility: Arena 1431
city: Debrecen
country: Hungary
facility: Arena 1505
city: Debrecen
country: Hungary
facility: Arena 1474
city: Szombathely
country: Hungary
facility: Arena 1477
city: Beer Sheva
country: Israel
facility: Arena 1705
city: Haifa
country: Israel
facility: Arena 1702
city: Holon
country: Israel
facility: Arena 1706
city: Jerusalem
country: Israel
facility: Arena 1704
city: Petah-Tikva
country: Israel
facility: Arena 1703
city: Busan
country: Korea, Republic of
facility: Arena 1613
city: Daegu
country: Korea, Republic of
facility: Arena 1614
city: Incheon
country: Korea, Republic of
facility: Arena 1610
city: Seoul
country: Korea, Republic of
facility: Arena 1612
city: Seoul
country: Korea, Republic of
facility: Arena 1611
city: Suwon-si
country: Korea, Republic of
facility: Arena 1608
city: Wonju
country: Korea, Republic of
facility: Arena 1615
city: Riga
country: Latvia
facility: Arena 1462
city: Riga
country: Latvia
facility: Arena 1475
city: Vilnius
country: Lithuania
facility: Arena 1484
city: Christchurch
country: New Zealand
facility: Arena 1601
city: Bydgoszcz
country: Poland
facility: Arena 1439
city: Elblag
country: Poland
facility: Arena 1486
city: Kielce
country: Poland
facility: Arena 1495
city: Krakow
country: Poland
facility: Arena 1451
city: Lodz
country: Poland
facility: Arena 1438
city: Posen
country: Poland
facility: Arena 1458
city: Rzeszow
country: Poland
facility: Arena 1428
city: Sopot
country: Poland
facility: Arena 1456
city: Wroclaw
country: Poland
facility: Arena 1494
city: Bucharest
country: Romania
facility: Arena 1441
city: Bucharest
country: Romania
facility: Arena 1491
city: Bucharest
country: Romania
facility: Arena 1406
city: Iasi
country: Romania
facility: Arena 1436
city: Oradea
country: Romania
facility: Arena 1420
city: Timisoara
country: Romania
facility: Arena 1405
city: Timisoara
country: Romania
facility: Arena 1493
city: Kazan'
country: Russian Federation
facility: Arena 1440
city: Krasnoyarsk
country: Russian Federation
facility: Arena 1500
city: Novosibirsk
country: Russian Federation
facility: Arena 1504
city: Rostov on Don
country: Russian Federation
facility: Arena 1419
city: Ryazan'
country: Russian Federation
facility: Arena 1452
city: Saint Petersburg
country: Russian Federation
facility: Arena 1498
city: Saint Petersburg
country: Russian Federation
facility: Arena 1467
city: Saint Petersburg
country: Russian Federation
facility: Arena 1448
city: Saint Petersburg
country: Russian Federation
facility: Arena 1447
city: Samara
country: Russian Federation
facility: Arena 1465
city: Barcelona
country: Spain
facility: Arena 1403
city: Barcelona
country: Spain
facility: Arena 1460
city: Madrid
country: Spain
facility: Arena 1481
city: Pontevedra
country: Spain
facility: Arena 1430
city: Santiago de Compostela
country: Spain
facility: Arena 1432
city: Sevilla
country: Spain
facility: Arena 1469
city: Chernivtsi
country: Ukraine
facility: Arena 1424
city: Ivano-Frankivsk
country: Ukraine
facility: Arena 1445
city: Kharkov
country: Ukraine
facility: Arena 1454
city: Kharkov
country: Ukraine
facility: Arena 1459
city: Kiev
country: Ukraine
facility: Arena 1466
city: Kyiv
country: Ukraine
facility: Arena 1408
city: Kyiv
country: Ukraine
facility: Arena 1502
city: Kyiv
country: Ukraine
facility: Arena 1506
city: Odessa
country: Ukraine
facility: Arena 1414
city: Uzhgorod
country: Ukraine
facility: Arena 1433
city: Vinnytsia
country: Ukraine
facility: Arena 1501
city: Vinnytsya
country: Ukraine
facility: Arena 1416
city: London
country: United Kingdom
facility: Arena 1302
city: Torquay
country: United Kingdom
facility: Arena 1304
city: Wolverhampton
country: United Kingdom
facility: Arena 1303
Study officials:
affiliation: Arena Pharmaceuticals
name: Arena CT.gov Administrator
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kuhbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panes J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.