Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
- Registration Number
- NCT02447302
- Lead Sponsor
- Arena Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
- Evidence of colonic ulcerative colitis activity on endoscopy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral, placebo, daily for 12 weeks. Etrasimod Low Dose Etrasimod Oral, low dose, daily for 12 Weeks Etrasimod High Dose Etrasimod Oral, high dose, daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline in Adapted Mayo Score (MCS) at Week 12 Baseline and 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 Week 12 For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.
Change From Baseline in Total Mayo Score (TMS) at Week 12 Baseline and Week 12 The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores \[stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score\], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Change From Baseline in 2-component MCS at Week 12 Baseline and Week 12 The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Trial Locations
- Locations (134)
Arena 1103
🇺🇸Ogden, Utah, United States
Arena 1409
🇧🇬Sofia, Bulgaria
Arena 1102
🇺🇸Hermitage, Tennessee, United States
Arena 1486
🇵🇱Elblag, Poland
Arena 1447
🇷🇺Saint Petersburg, Russian Federation
Arena 1439
🇵🇱Bydgoszcz, Poland
Arena 1428
🇵🇱Rzeszow, Poland
Arena 1441
🇷🇴Bucharest, Romania
Arena 1491
🇷🇴Bucharest, Romania
Arena 1436
🇷🇴Iasi, Romania
Arena 1495
🇵🇱Kielce, Poland
Arena 1438
🇵🇱Lodz, Poland
Arena 1452
🇷🇺Ryazan', Russian Federation
Arena 1498
🇷🇺Saint Petersburg, Russian Federation
Arena 1458
🇵🇱Posen, Poland
Arena 1420
🇷🇴Oradea, Romania
Arena 1405
🇷🇴Timisoara, Romania
Arena 1440
🇷🇺Kazan', Russian Federation
Arena 1500
🇷🇺Krasnoyarsk, Russian Federation
Arena 1493
🇷🇴Timisoara, Romania
Arena 1504
🇷🇺Novosibirsk, Russian Federation
Arena 1419
🇷🇺Rostov on Don, Russian Federation
Arena 1467
🇷🇺Saint Petersburg, Russian Federation
Arena 1445
🇺🇦Ivano-Frankivsk, Ukraine
Arena 1506
🇺🇦Kyiv, Ukraine
Arena 1433
🇺🇦Uzhgorod, Ukraine
Arena 1501
🇺🇦Vinnytsia, Ukraine
Arena 1466
🇺🇦Kiev, Ukraine
Arena 1408
🇺🇦Kyiv, Ukraine
Arena 1502
🇺🇦Kyiv, Ukraine
Arena 1414
🇺🇦Odessa, Ukraine
Arena 1109
🇺🇸Great Neck, New York, United States
Arena 1406
🇷🇴Bucharest, Romania
Arena 1133
🇺🇸Dothan, Alabama, United States
Arena 1143
🇺🇸Thousand Oaks, California, United States
Arena 1127
🇺🇸Urbana, Illinois, United States
Arena 1123
🇺🇸Naples, Florida, United States
Arena 1136
🇺🇸DeSoto, Texas, United States
Arena 1137
🇺🇸Sweetwater, Florida, United States
Arena 1139
🇺🇸Hoffman Estates, Illinois, United States
Arena 1607
🇦🇺Subiaco, Australia
Arena 1111
🇺🇸Troy, Michigan, United States
Arena 1141
🇺🇸Orlando, Florida, United States
Arena 1604
🇦🇺Kingswood, Australia
Arena 1456
🇵🇱Sopot, Poland
Arena 1107
🇺🇸Hollywood, Florida, United States
Arena 1142
🇺🇸Traverse City, Michigan, United States
Arena 1106
🇺🇸Port Orange, Florida, United States
Arena 1105
🇺🇸Germantown, Tennessee, United States
Arena 1484
🇱🇹Vilnius, Lithuania
Arena 1494
🇵🇱Wroclaw, Poland
Arena 1116
🇺🇸Temple, Texas, United States
Arena 1601
🇳🇿Christchurch, New Zealand
Arena 1118
🇺🇸Raleigh, North Carolina, United States
Arena 1475
🇱🇻Riga, Latvia
Arena 1451
🇵🇱Krakow, Poland
Arena 1130
🇺🇸Richmond, Virginia, United States
Arena 1417
🇧🇬Sofia, Bulgaria
Arena 1204
🇨🇦Toronto, Ontario, Canada
Arena 1462
🇱🇻Riga, Latvia
Arena 1418
🇫🇷Clichy, France
Arena 1702
🇮🇱Haifa, Israel
Arena 1303
🇬🇧Wolverhampton, United Kingdom
Arena 1432
🇪🇸Santiago de Compostela, Spain
Arena 1424
🇺🇦Chernivtsi, Ukraine
Arena 1459
🇺🇦Kharkov, Ukraine
Arena 1469
🇪🇸Sevilla, Spain
Arena 1302
🇬🇧London, United Kingdom
Arena 1448
🇷🇺Saint Petersburg, Russian Federation
Arena 1454
🇺🇦Kharkov, Ukraine
Arena 1416
🇺🇦Vinnytsya, Ukraine
Arena 1481
🇪🇸Madrid, Spain
Arena 1304
🇬🇧Torquay, United Kingdom
Arena 1430
🇪🇸Pontevedra, Spain
Arena 1131
🇺🇸Chicago, Illinois, United States
Arena 1117
🇺🇸Pittsburgh, Pennsylvania, United States
Arena 1121
🇺🇸Houston, Texas, United States
Arena 1202
🇨🇦Winnipeg, Manitoba, Canada
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 1605
🇦🇺Randwick, Australia
Arena 1490
🇦🇹Wien, Austria
Arena 1472
🇧🇪Edegem, Belgium
Arena 1464
🇧🇪Kortrijk, Belgium
Arena 1473
🇧🇪Löwen, Belgium
Arena 1421
🇧🇬Ruse, Bulgaria
Arena 1410
🇧🇬Sofia, Bulgaria
Arena 1407
🇧🇬Sofia, Bulgaria
Arena 1425
🇧🇬Varna, Bulgaria
Arena 1210
🇨🇦Bridgewater, Nova Scotia, Canada
Arena 1208
🇨🇦Sudbury, Ontario, Canada
Arena 1209
🇨🇦Sudbury, Ontario, Canada
Arena 1206
🇨🇦London, Ontario, Canada
Arena 1455
🇨🇿Praha 4, Czechia
Arena 1443
🇫🇷Amiens Cedex 1, France
Arena 1437
🇫🇷Lille Cedex 1443, France
Arena 1476
🇫🇷Paris, France
Arena 1480
🇫🇷Pierre-Benite, France
Arena 1423
🇫🇷Saint-Etienne Cedex 1, France
Arena 1457
🇫🇷Vandoeuvre-les-Nancy, France
Arena 1479
🇩🇪Hamburg, Germany
Arena 1470
🇩🇪Hanover, Germany
Arena 1446
🇩🇪Kiel, Germany
Arena 1489
🇩🇪Leipzig, Germany
Arena 1497
🇩🇪Oldenburg, Germany
Arena 1478
🇭🇺Bekescsaba, Hungary
Arena 1444
🇩🇪Ulm, Germany
Arena 1471
🇭🇺Budapest, Hungary
Arena 1492
🇭🇺Budapest, Hungary
Arena 1431
🇭🇺Budapest, Hungary
Arena 1505
🇭🇺Debrecen, Hungary
Arena 1474
🇭🇺Debrecen, Hungary
Arena 1477
🇭🇺Szombathely, Hungary
Arena 1705
🇮🇱Beer Sheva, Israel
Arena 1706
🇮🇱Holon, Israel
Arena 1704
🇮🇱Jerusalem, Israel
Arena 1703
🇮🇱Petah-Tikva, Israel
Arena 1613
🇰🇷Busan, Korea, Republic of
Arena 1614
🇰🇷Daegu, Korea, Republic of
Arena 1610
🇰🇷Incheon, Korea, Republic of
Arena 1612
🇰🇷Seoul, Korea, Republic of
Arena 1608
🇰🇷Suwon-si, Korea, Republic of
Arena 1615
🇰🇷Wonju, Korea, Republic of
Arena 1465
🇷🇺Samara, Russian Federation
Arena 1403
🇪🇸Barcelona, Spain
Arena 1611
🇰🇷Seoul, Korea, Republic of
Arena 1422
🇩🇪Hamburg, Germany
Arena 1114
🇺🇸Rochester, New York, United States
Arena 1460
🇪🇸Barcelona, Spain
Arena 1119
🇺🇸Birmingham, Alabama, United States
Arena 1138
🇺🇸Miami, Florida, United States
Arena 1112
🇺🇸Cincinnati, Ohio, United States