Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
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
2 other identifiers
interventional
156
20 countries
131
Brief Summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2015
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedStudy Start
First participant enrolled
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2018
CompletedResults Posted
Study results publicly available
April 5, 2021
CompletedApril 5, 2021
March 1, 2021
2.3 years
May 13, 2015
February 12, 2021
March 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Adapted Mayo Score (MCS) at Week 12
The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Baseline and Week 12
Secondary Outcomes (3)
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
Week 12
Change From Baseline in 2-component MCS at Week 12
Baseline and Week 12
Change From Baseline in Total Mayo Score (TMS) at Week 12
Baseline and Week 12
Other Outcomes (3)
Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12
Week 12
Percentage of Participants Who Achieved Clinical Remission at Week 12
Week 12
Percentage of Participants Who Achieved Clinical Response at Week 12
Week 12
Study Arms (3)
Etrasimod Low Dose
EXPERIMENTALOral, low dose, daily for 12 Weeks
Etrasimod High Dose
EXPERIMENTALOral, high dose, daily for 12 weeks
Placebo
PLACEBO COMPARATOROral, placebo, daily for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
- Evidence of colonic ulcerative colitis activity on endoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Arena 1119
Birmingham, Alabama, 35294, United States
Arena 1133
Dothan, Alabama, 36305, United States
Arena 1143
Thousand Oaks, California, 91360, United States
Arena 1107
Hollywood, Florida, 33021, United States
Arena 1138
Miami, Florida, 33134, United States
Arena 1123
Naples, Florida, 34102, United States
Arena 1141
Orlando, Florida, 32825, United States
Arena 1106
Port Orange, Florida, 32127, United States
Arena 1137
Sweetwater, Florida, 33172, United States
Arena 1131
Chicago, Illinois, 60611, United States
Arena 1139
Hoffman Estates, Illinois, 60169, United States
Arena 1127
Urbana, Illinois, 61801, United States
Arena 1142
Traverse City, Michigan, 49686, United States
Arena 1111
Troy, Michigan, 48098, United States
Arena 1109
Great Neck, New York, 11021, United States
Arena 1114
Rochester, New York, 14642, United States
Arena 1118
Raleigh, North Carolina, 27612, United States
Arena 1112
Cincinnati, Ohio, 45267, United States
Arena 1117
Pittsburgh, Pennsylvania, 15219, United States
Arena 1105
Germantown, Tennessee, 38138, United States
Arena 1102
Hermitage, Tennessee, 37076, United States
Arena 1136
DeSoto, Texas, 75115, United States
Arena 1121
Houston, Texas, 77030, United States
Arena 1116
Temple, Texas, 76508, United States
Arena 1103
Ogden, Utah, 84405, United States
Arena 1130
Richmond, Virginia, 23298, United States
Arena 1128
Roanoke, Virginia, 24014, United States
Arena 1115
Seattle, Washington, 98101, United States
Arena 1101
Seattle, Washington, 98195, United States
Arena 1108
Wauwatosa, Wisconsin, 53226, United States
Arena 1604
Kingswood, 2747, Australia
Arena 1605
Randwick, 2031, Australia
Arena 1607
Subiaco, 6008, Australia
Arena 1490
Vienna, 1090, Austria
Arena 1472
Edegem, 2650, Belgium
Arena 1464
Kortrijk, 8500, Belgium
Arena 1473
Leuven, 3000, Belgium
Arena 1421
Rousse, 7002, Bulgaria
Arena 1409
Sofia, 1407, Bulgaria
Arena 1410
Sofia, 1407, Bulgaria
Arena 1417
Sofia, 1407, Bulgaria
Arena 1407
Sofia, 1797, Bulgaria
Arena 1425
Varna, 9010, Bulgaria
Arena 1202
Winnipeg, Manitoba, R3A 1R9, Canada
Arena 1210
Bridgewater, Nova Scotia, B4V 3N2, Canada
Arena 1208
Greater Sudbury, Ontario, P3E 1H5, Canada
Arena 1209
Greater Sudbury, Ontario, P3E 6C3, Canada
Arena 1206
London, Ontario, N6A 4G5, Canada
Arena 1204
Toronto, Ontario, M5G 1X5, Canada
Arena 1455
Prague, 140 59, Czechia
Arena 1443
Amiens, 80054, France
Arena 1418
Clichy, 92110, France
Arena 1437
Lille, 59037, France
Arena 1476
Paris, 75010, France
Arena 1480
Pierre-Bénite, 693110, France
Arena 1423
Saint-Etienne, 42055, France
Arena 1457
Vandœuvre-lès-Nancy, 54511, France
Arena 1479
Hamburg, 20249, Germany
Arena 1422
Hamburg, Germany
Arena 1470
Hanover, 30625, Germany
Arena 1446
Kiel, 24105, Germany
Arena 1489
Leipzig, 04103, Germany
Arena 1497
Oldenburg, 26123, Germany
Arena 1444
Ulm, 89073, Germany
Arena 1478
Békéscsaba, 5600, Hungary
Arena 1471
Budapest, 1062, Hungary
Arena 1492
Budapest, 1062, Hungary
Arena 1431
Budapest, 1076, Hungary
Arena 1505
Debrecen, 4025, Hungary
Arena 1474
Debrecen, 4032, Hungary
Arena 1477
Szombathely, 9700, Hungary
Arena 1705
Beersheba, 84101, Israel
Arena 1702
Haifa, 31096, Israel
Arena 1706
Holon, 58100, Israel
Arena 1704
Jerusalem, 91031, Israel
Arena 1703
Petah Tikva, 49100, Israel
Arena 1462
Riga, 1002, Latvia
Arena 1475
Riga, 1006, Latvia
Arena 1484
Vilnius, 8661, Lithuania
Arena 1601
Christchurch, 8011, New Zealand
Arena 1439
Bydgoszcz, 85-681, Poland
Arena 1486
Elblag, 03-580, Poland
Arena 1495
Kielce, 25-364, Poland
Arena 1451
Krakow, 31-009, Poland
Arena 1438
Lodz, 90-302, Poland
Arena 1458
Poznan, 61-485, Poland
Arena 1428
Rzeszów, 35-068, Poland
Arena 1456
Sopot, 81-756, Poland
Arena 1494
Wroclaw, 54-144, Poland
Arena 1441
Bucharest, 050098, Romania
Arena 1491
Bucharest, 10719, Romania
Arena 1406
Bucharest, Romania
Arena 1436
Iași, 700506, Romania
Arena 1420
Oradea, 410159, Romania
Arena 1405
Timișoara, 300002, Romania
Arena 1493
Timișoara, 300736, Romania
Arena 1440
Kazan', 420029, Russia
Arena 1500
Krasnoyarsk, 660022, Russia
Arena 1504
Novosibirsk, 630091, Russia
Arena 1419
Rostov-on-Don, 197022, Russia
Arena 1452
Ryazan, 197022, Russia
Arena 1498
Saint Petersburg, 191015, Russia
Arena 1467
Saint Petersburg, 195257, Russia
Arena 1448
Saint Petersburg, 344007, Russia
Arena 1447
Saint Petersburg, 603126, Russia
Arena 1465
Samara, 111539, Russia
Arena 1613
Busan, 49241, South Korea
Arena 1614
Daegu, 42415, South Korea
Arena 1610
Incheon, 21565, South Korea
Arena 1612
Seoul, 05505, South Korea
Arena 1611
Seoul, 06519, South Korea
Arena 1608
Suwon, 16247, South Korea
Arena 1615
Wŏnju, 26426, South Korea
Arena 1403
Barcelona, 08022, Spain
Arena 1460
Barcelona, 08036, Spain
Arena 1481
Madrid, 28046, Spain
Arena 1430
Pontevedra, 36071, Spain
Arena 1432
Santiago de Compostela, 15706, Spain
Arena 1469
Seville, 41007, Spain
Arena 1424
Chernivtsi, 3110, Ukraine
Arena 1445
Ivano-Frankivsk, 07601, Ukraine
Arena 1454
Kharkiv, 6100, Ukraine
Arena 1459
Kharkiv, 61039, Ukraine
Arena 1466
Kiev, 01030, Ukraine
Arena 1408
Kyiv, 01030, Ukraine
Arena 1502
Kyiv, 01133, Ukraine
Arena 1506
Kyiv, 02091, Ukraine
Arena 1414
Odesa, 65025, Ukraine
Arena 1433
Uzhhorod, 88000, Ukraine
Arena 1416
Vinnytsia, 21018, Ukraine
Arena 1501
Vinnytsia, 21029, Ukraine
Arena 1302
London, E1 1BB, United Kingdom
Arena 1304
Torquay, TQ2 7AA, United Kingdom
Arena 1303
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (4)
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.
PMID: 39778975DERIVEDLees CW, Torres J, Leung Y, Vermeire S, Fellmann M, Modesto I, McDonnell A, Lazin K, Keating M, Goetsch M, Wu J, Loftus EV Jr. Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. Therap Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024.
PMID: 39526078DERIVEDYarur AJ, Chiorean MV, Panes J, Jairath V, Zhang J, Rabbat CJ, Sandborn WJ, Vermeire S, Peyrin-Biroulet L. Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial. J Crohns Colitis. 2024 Jun 3;18(6):885-894. doi: 10.1093/ecco-jcc/jjae007.
PMID: 38245818DERIVEDSandborn 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.
PMID: 31711921DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arena CT.gov Administrator
- Organization
- Arena Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Arena CT.gov Administrator
Arena Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 18, 2015
Study Start
October 15, 2015
Primary Completion
February 14, 2018
Study Completion
February 14, 2018
Last Updated
April 5, 2021
Results First Posted
April 5, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share