Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

March 10, 2021 updated by: Arena Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Kingswood, Australia, 2747
        • Arena 1604
      • Randwick, Australia, 2031
        • Arena 1605
      • Subiaco, Australia, 6008
        • Arena 1607
  • Austria
      • Wien, Austria, 1090
        • Arena 1490
  • Belgium
      • Edegem, Belgium, 2650
        • Arena 1472
      • Kortrijk, Belgium, 8500
        • Arena 1464
      • Löwen, Belgium, 3000
        • Arena 1473
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • Arena 1421
      • Sofia, Bulgaria, 1407
        • Arena 1417
      • Sofia, Bulgaria, 1797
        • Arena 1407
      • Sofia, Bulgaria, 1407
        • Arena 1409
      • Sofia, Bulgaria, 1407
        • Arena 1410
      • Varna, Bulgaria, 9010
        • Arena 1425
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Arena 1202
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 3N2
        • Arena 1210
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Arena 1206
      • Sudbury, Ontario, Canada, P3E 1H5
        • Arena 1208
      • Sudbury, Ontario, Canada, P3E 6C3
        • Arena 1209
      • Toronto, Ontario, Canada, M5G 1X5
        • Arena 1204
  • Czechia
      • Praha 4, Czechia, 140 59
        • Arena 1455
  • France
      • Amiens Cedex 1, France, 80054
        • Arena 1443
      • Clichy, France, 92110
        • Arena 1418
      • Lille Cedex 1443, France, 59037
        • Arena 1437
      • Paris, France, 75010
        • Arena 1476
      • Pierre-Benite, France, 693110
        • Arena 1480
      • Saint-Etienne Cedex 1, France, 42055
        • Arena 1423
      • Vandoeuvre-les-Nancy, France, 54511
        • Arena 1457
  • Germany
      • Hamburg, Germany, 20249
        • Arena 1479
      • Hamburg, Germany
        • Arena 1422
      • Hanover, Germany, 30625
        • Arena 1470
      • Kiel, Germany, 24105
        • Arena 1446
      • Leipzig, Germany, 04103
        • Arena 1489
      • Oldenburg, Germany, 26123
        • Arena 1497
      • Ulm, Germany, 89073
        • Arena 1444
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Arena 1478
      • Budapest, Hungary, 1062
        • Arena 1471
      • Budapest, Hungary, 1062
        • Arena 1492
      • Budapest, Hungary, 1076
        • Arena 1431
      • Debrecen, Hungary, 4025
        • Arena 1505
      • Debrecen, Hungary, 4032
        • Arena 1474
      • Szombathely, Hungary, 9700
        • Arena 1477
  • Israel
      • Beer Sheva, Israel, 84101
        • Arena 1705
      • Haifa, Israel, 31096
        • Arena 1702
      • Holon, Israel, 58100
        • Arena 1706
      • Jerusalem, Israel, 91031
        • Arena 1704
      • Petah-Tikva, Israel, 49100
        • Arena 1703
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Arena 1613
      • Daegu, Korea, Republic of, 42415
        • Arena 1614
      • Incheon, Korea, Republic of, 21565
        • Arena 1610
      • Seoul, Korea, Republic of, 05505
        • Arena 1612
      • Seoul, Korea, Republic of, 06519
        • Arena 1611
      • Suwon-si, Korea, Republic of, 16247
        • Arena 1608
      • Wonju, Korea, Republic of, 26426
        • Arena 1615
  • Latvia
      • Riga, Latvia, 1002
        • Arena 1462
      • Riga, Latvia, 1006
        • Arena 1475
  • Lithuania
      • Vilnius, Lithuania, 8661
        • Arena 1484
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Arena 1601
  • Poland
      • Bydgoszcz, Poland, 85-681
        • Arena 1439
      • Elblag, Poland, 03-580
        • Arena 1486
      • Kielce, Poland, 25-364
        • Arena 1495
      • Krakow, Poland, 31-009
        • Arena 1451
      • Lodz, Poland, 90-302
        • Arena 1438
      • Posen, Poland, 61-485
        • Arena 1458
      • Rzeszow, Poland, 35-068
        • Arena 1428
      • Sopot, Poland, 81-756
        • Arena 1456
      • Wroclaw, Poland, 54-144
        • Arena 1494
  • Romania
      • Bucharest, Romania, 050098
        • Arena 1441
      • Bucharest, Romania, 10719
        • Arena 1491
      • Bucharest, Romania
        • Arena 1406
      • Iasi, Romania, 700506
        • Arena 1436
      • Oradea, Romania, 410159
        • Arena 1420
      • Timisoara, Romania, 300002
        • Arena 1405
      • Timisoara, Romania, 300736
        • Arena 1493
  • Russian Federation
      • Kazan', Russian Federation, 420029
        • Arena 1440
      • Krasnoyarsk, Russian Federation, 660022
        • Arena 1500
      • Novosibirsk, Russian Federation, 630091
        • Arena 1504
      • Rostov on Don, Russian Federation, 197022
        • Arena 1419
      • Ryazan', Russian Federation, 197022
        • Arena 1452
      • Saint Petersburg, Russian Federation, 191015
        • Arena 1498
      • Saint Petersburg, Russian Federation, 195257
        • Arena 1467
      • Saint Petersburg, Russian Federation, 344007
        • Arena 1448
      • Saint Petersburg, Russian Federation, 603126
        • Arena 1447
      • Samara, Russian Federation, 111539
        • Arena 1465
  • Spain
      • Barcelona, Spain, 08022
        • Arena 1403
      • Barcelona, Spain, 08036
        • Arena 1460
      • Madrid, Spain, 28046
        • Arena 1481
      • Pontevedra, Spain, 36071
        • Arena 1430
      • Santiago de Compostela, Spain, 15706
        • Arena 1432
      • Sevilla, Spain, 41007
        • Arena 1469
  • Ukraine
      • Chernivtsi, Ukraine, 3110
        • Arena 1424
      • Ivano-Frankivsk, Ukraine, 07601
        • Arena 1445
      • Kharkov, Ukraine, 61039
        • Arena 1459
      • Kharkov, Ukraine, 6100
        • Arena 1454
      • Kiev, Ukraine, 01030
        • Arena 1466
      • Kyiv, Ukraine, 01030
        • Arena 1408
      • Kyiv, Ukraine, 02091
        • Arena 1506
      • Kyiv, Ukraine, 01133
        • Arena 1502
      • Odessa, Ukraine, 65025
        • Arena 1414
      • Uzhgorod, Ukraine, 88000
        • Arena 1433
      • Vinnytsia, Ukraine, 21029
        • Arena 1501
      • Vinnytsya, Ukraine, 21018
        • Arena 1416
  • United Kingdom
      • London, United Kingdom, E1 1BB
        • Arena 1302
      • Torquay, United Kingdom, TQ2 7AA
        • Arena 1304
      • Wolverhampton, United Kingdom, WV10 0QP
        • Arena 1303
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Arena 1119
      • Dothan, Alabama, United States, 36305
        • Arena 1133
    • California
      • Thousand Oaks, California, United States, 91360
        • Arena 1143
    • Florida
      • Hollywood, Florida, United States, 33021
        • Arena 1107
      • Miami, Florida, United States, 33134
        • Arena 1138
      • Naples, Florida, United States, 34102
        • Arena 1123
      • Orlando, Florida, United States, 32825
        • Arena 1141
      • Port Orange, Florida, United States, 32127
        • Arena 1106
      • Sweetwater, Florida, United States, 33172
        • Arena 1137
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Arena 1131
      • Hoffman Estates, Illinois, United States, 60169
        • Arena 1139
      • Urbana, Illinois, United States, 61801
        • Arena 1127
    • Michigan
      • Traverse City, Michigan, United States, 49686
        • Arena 1142
      • Troy, Michigan, United States, 48098
        • Arena 1111
    • New York
      • Great Neck, New York, United States, 11021
        • Arena 1109
      • Rochester, New York, United States, 14642
        • Arena 1114
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Arena 1118
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Arena 1112
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • Arena 1117
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Arena 1105
      • Hermitage, Tennessee, United States, 37076
        • Arena 1102
    • Texas
      • DeSoto, Texas, United States, 75115
        • Arena 1136
      • Houston, Texas, United States, 77030
        • Arena 1121
      • Temple, Texas, United States, 76508
        • Arena 1116
    • Utah
      • Ogden, Utah, United States, 84405
        • Arena 1103
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Arena 1130
      • Roanoke, Virginia, United States, 24014
        • Arena 1128
    • Washington
      • Seattle, Washington, United States, 98101
        • Arena 1115
      • Seattle, Washington, United States, 98195
        • Arena 1101
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Arena 1108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etrasimod Low Dose
Oral, low dose, daily for 12 Weeks
Drug: Etrasimod
Other Names:
  • APD334
Experimental: Etrasimod High Dose
Oral, high dose, daily for 12 weeks
Drug: Etrasimod
Other Names:
  • APD334
Placebo Comparator: Placebo
Oral, placebo, daily for 12 weeks.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Adapted Mayo Score (MCS) at Week 12
Time Frame: 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.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
Time Frame: 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.
Week 12
Change From Baseline in 2-component MCS at Week 12
Time Frame: 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.
Baseline and Week 12
Change From Baseline in Total Mayo Score (TMS) at Week 12
Time Frame: 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.
Baseline and Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12
Time Frame: Week 12
The trichotomous composite score of clinical remission and clinical response at Week 12 is an ordinal categorical endpoint with 3 categories (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response, and 0 for achieving neither). Multiple imputation method was used to handle missing data.
Week 12
Percentage of Participants Who Achieved Clinical Remission at Week 12
Time Frame: Week 12
A participant was considered to have achieved clinical remission if he/she had: 1) an endoscopy score using flexible proctosigmoidoscopy of 0 or 1 (excluding friability), 2) a rectal bleeding score of 0 or 1, and 3) a stool frequency score of 0 or 1 with a decrease of ≥1 point from baseline. Multiple imputation method was used to handle missing data.
Week 12
Percentage of Participants Who Achieved Clinical Response at Week 12
Time Frame: Week 12
A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission defined above, or met criteria of clinical response. Clinical response was defined as a decrease in the adapted MCS of ≥ 2 points and a decrease of ≥ 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arena Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2015

Primary Completion (Actual)

February 14, 2018

Study Completion (Actual)

February 14, 2018

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD334-003
  • 2015-001942-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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