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Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Etrasimod
Placebo
Sponsored by
Arena Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who completed the APD334-003 (NCT02447302) study

Exclusion Criteria:

  • Participants who did not complete the APD334-003 study

Sites / Locations

  • Arena 1119
  • Arena 1133
  • Arena 1143
  • Arena 1107
  • Arena 1138
  • Arena 1123
  • Arena 1141
  • Arena 1106
  • Arena 1137
  • Arena 1131
  • Arena 1139
  • Arena 1127
  • Arena 1113
  • Arena 1142
  • Arena 1111
  • Arena 1109
  • Arena 1114
  • Arena 1118
  • Arena 1112
  • Arena 1117
  • Arena 1105
  • Arena 1102
  • Arena 1136
  • Arena 1121
  • Arena 1116
  • Arena 1103
  • Arena 1130
  • Arena 1128
  • Arena 1115
  • Arena 1101
  • Arena 1108
  • Arena 1604
  • Arena 1605
  • Arena 1607
  • Arena 1490
  • Arena 1472
  • Arena 1464
  • Arena 1473
  • Arena 1421
  • Arena 1417
  • Arena 1410
  • Arena 1409
  • Arena 1407
  • Arena 1425
  • Arena 1202
  • Arena 1210
  • Arena 1206
  • Arena 1208
  • Arena 1209
  • Arena 1204
  • Arena 1455
  • Arena 1443
  • Arena 1418
  • Arena 1437
  • Arena 1476
  • Arena 1480
  • Arena 1423
  • Arena 1457
  • Arena 1479
  • Arena 1422
  • Arena 1470
  • Arena 1446
  • Arena 1489
  • Arena 1497
  • Arena 1444
  • Arena 1478
  • Arena 1431
  • Arena 1471
  • Arena 1492
  • Arena 1505
  • Arena 1474
  • Arena 1477
  • Arena 1705
  • Arena 1702
  • Arena 1706
  • Arena 1704
  • Arena 1703
  • Arena 1615
  • Arena 1614
  • Arena 1610
  • Arena 1462
  • Arena 1475
  • Arena 1484
  • Arena 1601
  • Arena 1439
  • Arena 1486
  • Arena 1495
  • Arena 1451
  • Arena 1438
  • Arena 1458
  • Arena 1428
  • Arena 1456
  • Arena 1494
  • Arena 1491
  • Arena 1406
  • Arena 1441
  • Arena 1436
  • Arena 1420
  • Arena 1405
  • Arena 1493
  • Arena 1500
  • Arena 1504
  • Arena 1419
  • Arena 1498
  • Arena 1448
  • Arena 1465
  • Arena 1403
  • Arena 1460
  • Arena 1481
  • Arena 1430
  • Arena 1432
  • Arena 1469
  • Arena 1424
  • Arena 1445
  • Arena 1454
  • Arena 1459
  • Arena 1466
  • Arena 1411
  • Arena 1408
  • Arena 1506
  • Arena 1414
  • Arena 1433
  • Arena 1501
  • Arena 1416
  • Arena 1302
  • Arena 1304
  • Arena 1303

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Etrasimod 2 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.

Secondary Outcome Measures

Proportion of Participants Who Achieved Clinical Response
A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005
A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Proportion of Participants Who Achieved Clinical Remission
A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005
A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

Full Information

First Posted
August 24, 2015
Last Updated
November 24, 2021
Sponsor
Arena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02536404
Brief Title
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Official Title
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2016 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arena Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etrasimod 2 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Etrasimod
Other Intervention Name(s)
APD334
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Description
A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Time Frame
Up to Week 48 (up to 30 days following discontinuation of the study drug)
Secondary Outcome Measure Information:
Title
Proportion of Participants Who Achieved Clinical Response
Description
A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Time Frame
Week 46 (extension study APD334-005)
Title
Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005
Description
A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Time Frame
Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)
Title
Proportion of Participants Who Achieved Clinical Remission
Description
A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Time Frame
Week 46 (extension study APD334-005)
Title
Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005
Description
A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Time Frame
Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who completed the APD334-003 (NCT02447302) study Exclusion Criteria: Participants who did not complete the APD334-003 study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arena CT.gov Administrator
Organizational Affiliation
Arena Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arena 1119
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arena 1133
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Arena 1143
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Arena 1107
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Arena 1138
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Arena 1123
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Arena 1141
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Arena 1106
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Arena 1137
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Arena 1131
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Arena 1139
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Arena 1127
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Arena 1113
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Arena 1142
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49686
Country
United States
Facility Name
Arena 1111
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Arena 1109
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Arena 1114
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Arena 1118
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Arena 1112
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Arena 1117
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Arena 1105
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Arena 1102
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Arena 1136
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Arena 1121
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Arena 1116
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Arena 1103
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Arena 1130
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Arena 1128
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Arena 1115
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Arena 1101
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Arena 1108
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Arena 1604
City
Kingswood
ZIP/Postal Code
2747
Country
Australia
Facility Name
Arena 1605
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Arena 1607
City
Subiaco
ZIP/Postal Code
6008
Country
Australia
Facility Name
Arena 1490
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Arena 1472
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Arena 1464
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Arena 1473
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Arena 1421
City
Ruse
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Arena 1417
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Arena 1410
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Arena 1409
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Arena 1407
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
Arena 1425
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Arena 1202
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Arena 1210
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B4V 3N2
Country
Canada
Facility Name
Arena 1206
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Arena 1208
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 1H5
Country
Canada
Facility Name
Arena 1209
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 6C3
Country
Canada
Facility Name
Arena 1204
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Arena 1455
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Arena 1443
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Arena 1418
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Arena 1437
City
Lille Cedex 1443
ZIP/Postal Code
59037
Country
France
Facility Name
Arena 1476
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Arena 1480
City
Pierre-Benite
ZIP/Postal Code
693110
Country
France
Facility Name
Arena 1423
City
Saint-Etienne Cedex 1
ZIP/Postal Code
42055
Country
France
Facility Name
Arena 1457
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Arena 1479
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Arena 1422
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Arena 1470
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Arena 1446
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Arena 1489
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Arena 1497
City
Oldenburg
ZIP/Postal Code
26123
Country
Germany
Facility Name
Arena 1444
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Arena 1478
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Arena 1431
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Arena 1471
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Arena 1492
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Arena 1505
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Arena 1474
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Arena 1477
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Arena 1705
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Arena 1702
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Arena 1706
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Arena 1704
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Arena 1703
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Arena 1615
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Arena 1614
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Arena 1610
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Arena 1462
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Arena 1475
City
Riga
ZIP/Postal Code
1006
Country
Latvia
Facility Name
Arena 1484
City
Vilnius
ZIP/Postal Code
8661
Country
Lithuania
Facility Name
Arena 1601
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Arena 1439
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Arena 1486
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Arena 1495
City
Kielce
ZIP/Postal Code
25-364
Country
Poland
Facility Name
Arena 1451
City
Krakow
ZIP/Postal Code
31-009
Country
Poland
Facility Name
Arena 1438
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Arena 1458
City
Poznań
ZIP/Postal Code
60-856
Country
Poland
Facility Name
Arena 1428
City
Rzeszow
ZIP/Postal Code
35-068
Country
Poland
Facility Name
Arena 1456
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Arena 1494
City
Wroclaw
ZIP/Postal Code
54-144
Country
Poland
Facility Name
Arena 1491
City
Bucharest
ZIP/Postal Code
010719
Country
Romania
Facility Name
Arena 1406
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Arena 1441
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Arena 1436
City
Iasi
ZIP/Postal Code
700506
Country
Romania
Facility Name
Arena 1420
City
Oradea
ZIP/Postal Code
410159
Country
Romania
Facility Name
Arena 1405
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Arena 1493
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Arena 1500
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Arena 1504
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Arena 1419
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Arena 1498
City
Saint Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Arena 1448
City
Saint Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
Arena 1465
City
Samara
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
Arena 1403
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Arena 1460
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Arena 1481
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Arena 1430
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Arena 1432
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Arena 1469
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Arena 1424
City
Chernivtsi
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Arena 1445
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Arena 1454
City
Kharkov
ZIP/Postal Code
06100
Country
Ukraine
Facility Name
Arena 1459
City
Kharkov
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Arena 1466
City
Kiev
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Arena 1411
City
Kiev
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
Arena 1408
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Arena 1506
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Arena 1414
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Arena 1433
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Arena 1501
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Arena 1416
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Arena 1302
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Arena 1304
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Arena 1303
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://academic.oup.com/ecco-jcc/article/15/6/950/6105062
Description
Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study

Learn more about this trial

Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

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