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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536404
• Other study ID #: APD334-005
• Status: Completed
• Phase: Phase 2
• Start date: January 25, 2016
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2021
• Source: Arena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Participants who did not complete the APD334-003 study

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Etrasimod

• Placebo

Locations

Country	Name	City	State
Australia	Arena 1604	Kingswood
Australia	Arena 1605	Randwick
Australia	Arena 1607	Subiaco
Austria	Arena 1490	Wien
Belgium	Arena 1472	Edegem
Belgium	Arena 1464	Kortrijk
Belgium	Arena 1473	Leuven
Bulgaria	Arena 1421	Ruse
Bulgaria	Arena 1407	Sofia
Bulgaria	Arena 1409	Sofia
Bulgaria	Arena 1410	Sofia
Bulgaria	Arena 1417	Sofia
Bulgaria	Arena 1425	Varna
Canada	Arena 1210	Bridgewater	Nova Scotia
Canada	Arena 1206	London	Ontario
Canada	Arena 1208	Sudbury	Ontario
Canada	Arena 1209	Sudbury	Ontario
Canada	Arena 1204	Toronto	Ontario
Canada	Arena 1202	Winnipeg	Manitoba
Czechia	Arena 1455	Praha 4
France	Arena 1443	Amiens Cedex 1
France	Arena 1418	Clichy
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
Germany	Arena 1422	Hamburg
Germany	Arena 1479	Hamburg
Germany	Arena 1470	Hanover
Germany	Arena 1446	Kiel
Germany	Arena 1489	Leipzig
Germany	Arena 1497	Oldenburg
Germany	Arena 1444	Ulm
Hungary	Arena 1478	Bekescsaba
Hungary	Arena 1431	Budapest
Hungary	Arena 1471	Budapest
Hungary	Arena 1492	Budapest
Hungary	Arena 1474	Debrecen
Hungary	Arena 1505	Debrecen
Hungary	Arena 1477	Szombathely
Israel	Arena 1705	Beer Sheva
Israel	Arena 1702	Haifa
Israel	Arena 1706	Holon
Israel	Arena 1704	Jerusalem
Israel	Arena 1703	Petah-Tikva
Korea, Republic of	Arena 1614	Daegu
Korea, Republic of	Arena 1610	Incheon
Korea, Republic of	Arena 1615	Wonju	Gangwon-do
Latvia	Arena 1462	Riga
Latvia	Arena 1475	Riga
Lithuania	Arena 1484	Vilnius
New Zealand	Arena 1601	Christchurch
Poland	Arena 1439	Bydgoszcz
Poland	Arena 1486	Elblag
Poland	Arena 1495	Kielce
Poland	Arena 1451	Krakow
Poland	Arena 1438	Lodz
Poland	Arena 1458	Poznan
Poland	Arena 1428	Rzeszow
Poland	Arena 1456	Sopot
Poland	Arena 1494	Wroclaw
Romania	Arena 1406	Bucharest
Romania	Arena 1441	Bucharest
Romania	Arena 1491	Bucharest
Romania	Arena 1436	Iasi
Romania	Arena 1420	Oradea
Romania	Arena 1405	Timisoara
Romania	Arena 1493	Timisoara
Russian Federation	Arena 1500	Krasnoyarsk
Russian Federation	Arena 1504	Novosibirsk
Russian Federation	Arena 1419	Rostov-on-Don
Russian Federation	Arena 1448	Saint Petersburg
Russian Federation	Arena 1498	Saint Petersburg
Russian Federation	Arena 1465	Samara
Spain	Arena 1403	Barcelona
Spain	Arena 1460	Barcelona
Spain	Arena 1481	Madrid
Spain	Arena 1430	Pontevedra
Spain	Arena 1432	Santiago de Compostela
Spain	Arena 1469	Sevilla
Ukraine	Arena 1424	Chernivtsi
Ukraine	Arena 1445	Ivano-Frankivsk
Ukraine	Arena 1454	Kharkov
Ukraine	Arena 1459	Kharkov
Ukraine	Arena 1411	Kiev
Ukraine	Arena 1466	Kiev
Ukraine	Arena 1408	Kyiv
Ukraine	Arena 1506	Kyiv
Ukraine	Arena 1414	Odessa
Ukraine	Arena 1433	Uzhgorod
Ukraine	Arena 1501	Vinnytsia
Ukraine	Arena 1416	Vinnytsya
United Kingdom	Arena 1302	London
United Kingdom	Arena 1304	Torquay
United Kingdom	Arena 1303	Wolverhampton
United States	Arena 1119	Birmingham	Alabama
United States	Arena 1113	Chevy Chase	Maryland
United States	Arena 1131	Chicago	Illinois
United States	Arena 1112	Cincinnati	Ohio
United States	Arena 1136	DeSoto	Texas
United States	Arena 1133	Dothan	Alabama
United States	Arena 1105	Germantown	Tennessee
United States	Arena 1109	Great Neck	New York
United States	Arena 1102	Hermitage	Tennessee
United States	Arena 1139	Hoffman Estates	Illinois
United States	Arena 1107	Hollywood	Florida
United States	Arena 1121	Houston	Texas
United States	Arena 1138	Miami	Florida
United States	Arena 1123	Naples	Florida
United States	Arena 1103	Ogden	Utah
United States	Arena 1141	Orlando	Florida
United States	Arena 1117	Pittsburgh	Pennsylvania
United States	Arena 1106	Port Orange	Florida
United States	Arena 1118	Raleigh	North Carolina
United States	Arena 1130	Richmond	Virginia
United States	Arena 1128	Roanoke	Virginia
United States	Arena 1114	Rochester	New York
United States	Arena 1101	Seattle	Washington
United States	Arena 1115	Seattle	Washington
United States	Arena 1137	Sweetwater	Florida
United States	Arena 1116	Temple	Texas
United States	Arena 1143	Thousand Oaks	California
United States	Arena 1142	Traverse City	Michigan
United States	Arena 1111	Troy	Michigan
United States	Arena 1127	Urbana	Illinois
United States	Arena 1108	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Arena Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Korea, Republic of,  Latvia,  Lithuania,  New Zealand,  Poland,  Romania,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Week 48 (up to 30 days following discontinuation of the study drug)
Secondary	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.	Week 46 (extension study APD334-005)
Secondary	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.	Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)
Secondary	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.	Week 46 (extension study APD334-005)
Secondary	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.	Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

External Links

•   Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study