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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447302
• Other study ID #: APD334-003
• Secondary ID: 2015-001942-28
• Status: Completed
• Phase: Phase 2
• Start date: October 15, 2015
• Est. completion date: February 14, 2018

Study information

• Verified date: March 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 is a safe and effective treatment for ulcerative colitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: February 14, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

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	Löwen
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 1613	Busan
Korea, Republic of	Arena 1614	Daegu
Korea, Republic of	Arena 1610	Incheon
Korea, Republic of	Arena 1611	Seoul
Korea, Republic of	Arena 1612	Seoul
Korea, Republic of	Arena 1608	Suwon-si
Korea, Republic of	Arena 1615	Wonju
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	Posen
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 1440	Kazan'
Russian Federation	Arena 1500	Krasnoyarsk
Russian Federation	Arena 1504	Novosibirsk
Russian Federation	Arena 1419	Rostov on Don
Russian Federation	Arena 1452	Ryazan'
Russian Federation	Arena 1447	Saint Petersburg
Russian Federation	Arena 1448	Saint Petersburg
Russian Federation	Arena 1467	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 1466	Kiev
Ukraine	Arena 1408	Kyiv
Ukraine	Arena 1502	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 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
Other	Trichotomous Composite Score of Clinical Remission and Clinical Response at 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
Other	Percentage of Participants Who Achieved Clinical Remission at 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
Other	Percentage of Participants Who Achieved Clinical Response at 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
Primary	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	Percentage of Participants Who Achieved Endoscopic Improvement at 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
Secondary	Change From Baseline in 2-component MCS at 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
Secondary	Change From Baseline in Total Mayo Score (TMS) at 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