COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03950232




Registration number
NCT03950232
Ethics application status
Date submitted
13/05/2019
Date registered
15/05/2019
Date last updated
29/10/2020

Titles & IDs
Public title
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Scientific title
An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2018-003987-29
Secondary ID [2] 0 0
APD334-303
Universal Trial Number (UTN)
Trial acronym
ELEVATE UC OLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod

Experimental: Etrasimod 2 mg -


Treatment: Drugs: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant's country, whichever comes first

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and Severity of Safety Measures - Safety as assessed by the evaluation of adverse events
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
Timepoint [1] 0 0
Week 52, Week 104, Week 156, Week 208, and Week 260
Secondary outcome [2] 0 0
Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores
Timepoint [2] 0 0
Week 52, Week 104, Week 156, Week 208, and Week 260
Secondary outcome [3] 0 0
Proportion of Participants Achieving Symptomatic Remission Assessed by Mayo Component Sub-scores
Timepoint [3] 0 0
Week 52, Week 104, Week 156, Week 208, and Week 260
Secondary outcome [4] 0 0
Proportion of Participants Achieving Non-invasive Response Assessed by Mayo Component Sub-scores
Timepoint [4] 0 0
Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260
Secondary outcome [5] 0 0
Proportion of Participants Remaining in Clinical Remission Assessed by Mayo Component Sub-scores
Timepoint [5] 0 0
Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260
Secondary outcome [6] 0 0
Proportion of Participants Achieving Symptomatic Response Assessed by Mayo Component Sub-scores
Timepoint [6] 0 0
Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260
Secondary outcome [7] 0 0
Longitudinal change from both Open-Label Extension and Parent Study in Mayo Component Sub-scores
Timepoint [7] 0 0
Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260
Secondary outcome [8] 0 0
Proportion of Participants With Remission and Response Using Total Mayo Clinic Score
Timepoint [8] 0 0
Week 12, Week 52, up to Week 260
Secondary outcome [9] 0 0
Percentage of Participants With Histologic Improvement at Each Visit With Endoscopy Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Timepoint [9] 0 0
Up to approximately Week 260
Secondary outcome [10] 0 0
Percentage of Participants With Histologic Remission at Each Visit With Endoscopy Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Timepoint [10] 0 0
Up to Week 260
Secondary outcome [11] 0 0
Time to Loss of Response Assessed by Mayo Component Sub-scores
Timepoint [11] 0 0
Up to Week 260
Secondary outcome [12] 0 0
Proportion of Participants With Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline
Timepoint [12] 0 0
Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260

Eligibility
Key inclusion criteria
- Must have met the eligibility criteria and have been enrolled in one of the two parent
studies (APD334-301 or APD334-302) and also meet the following additional criteria:

1. Participants previously enrolled in Study APD334-301 must have completed the Week
12 visit and have been assessed to have active UC that had deteriorated from
baseline or completed the Week 52 visit

2. Participants previously enrolled in APD334 302 must have completed the Week 12
visit
Minimum age
16 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- If Investigator considers the participant to be unsuitable for any reason to
participate in the Open-Label Extension study

- Experienced an adverse event that led to discontinuation from one of the parent
studies

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [2] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
4740 - North Mackay
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Hampshire
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
West Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Belarus
State/province [29] 0 0
Gomel
Country [30] 0 0
Belarus
State/province [30] 0 0
Grodno
Country [31] 0 0
Belarus
State/province [31] 0 0
Minsk
Country [32] 0 0
Belarus
State/province [32] 0 0
Vitebsk
Country [33] 0 0
Belgium
State/province [33] 0 0
Antwerp
Country [34] 0 0
Belgium
State/province [34] 0 0
Gent
Country [35] 0 0
Belgium
State/province [35] 0 0
Leuven
Country [36] 0 0
Belgium
State/province [36] 0 0
Roeselare
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Pleven
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Plovdiv
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Ruse
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sliven
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Sofia
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Stara Zagora
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Veliko Tarnovo
Country [44] 0 0
Canada
State/province [44] 0 0
Alberta
Country [45] 0 0
Chile
State/province [45] 0 0
Santiago
Country [46] 0 0
Chile
State/province [46] 0 0
Talca
Country [47] 0 0
Chile
State/province [47] 0 0
Valdivia
Country [48] 0 0
Croatia
State/province [48] 0 0
Koprivnica
Country [49] 0 0
Croatia
State/province [49] 0 0
Zadar
Country [50] 0 0
Czechia
State/province [50] 0 0
Brno
Country [51] 0 0
Czechia
State/province [51] 0 0
Hradec Kralove
Country [52] 0 0
Czechia
State/province [52] 0 0
Klatovy
Country [53] 0 0
Czechia
State/province [53] 0 0
Olomouc
Country [54] 0 0
Czechia
State/province [54] 0 0
Ostrava-Poruba
Country [55] 0 0
Czechia
State/province [55] 0 0
Praha
Country [56] 0 0
Czechia
State/province [56] 0 0
Slany
Country [57] 0 0
Denmark
State/province [57] 0 0
Nordjylland
Country [58] 0 0
Denmark
State/province [58] 0 0
Herlev
Country [59] 0 0
Estonia
State/province [59] 0 0
Tallinn
Country [60] 0 0
Estonia
State/province [60] 0 0
Tartu
Country [61] 0 0
Georgia
State/province [61] 0 0
Tbilisi
Country [62] 0 0
Germany
State/province [62] 0 0
Berlin
Country [63] 0 0
Germany
State/province [63] 0 0
Schwerin
Country [64] 0 0
Hungary
State/province [64] 0 0
Balatonfured
Country [65] 0 0
Hungary
State/province [65] 0 0
Budapest
Country [66] 0 0
Hungary
State/province [66] 0 0
Gyongyos
Country [67] 0 0
Hungary
State/province [67] 0 0
Kaposvar
Country [68] 0 0
Hungary
State/province [68] 0 0
Szekszard
Country [69] 0 0
Hungary
State/province [69] 0 0
Székesfehérvár
Country [70] 0 0
Hungary
State/province [70] 0 0
Tatabanya
Country [71] 0 0
India
State/province [71] 0 0
Gujrat
Country [72] 0 0
India
State/province [72] 0 0
Maharashtra
Country [73] 0 0
India
State/province [73] 0 0
Rajasthan
Country [74] 0 0
Israel
State/province [74] 0 0
Afula
Country [75] 0 0
Israel
State/province [75] 0 0
Haifa
Country [76] 0 0
Israel
State/province [76] 0 0
Jerusalem
Country [77] 0 0
Israel
State/province [77] 0 0
Petach Tikva
Country [78] 0 0
Israel
State/province [78] 0 0
Ramat Gan
Country [79] 0 0
Israel
State/province [79] 0 0
Rehovot
Country [80] 0 0
Italy
State/province [80] 0 0
Verona
Country [81] 0 0
Italy
State/province [81] 0 0
Catania
Country [82] 0 0
Italy
State/province [82] 0 0
Catanzaro
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Gangwon-do
Country [84] 0 0
Latvia
State/province [84] 0 0
Riga
Country [85] 0 0
Lithuania
State/province [85] 0 0
Vilnius
Country [86] 0 0
Moldova, Republic of
State/province [86] 0 0
Chisinau
Country [87] 0 0
Netherlands
State/province [87] 0 0
Geleen
Country [88] 0 0
Netherlands
State/province [88] 0 0
Nijmegen
Country [89] 0 0
Netherlands
State/province [89] 0 0
Tilburg
Country [90] 0 0
Poland
State/province [90] 0 0
Bialystok
Country [91] 0 0
Poland
State/province [91] 0 0
Bedzin
Country [92] 0 0
Poland
State/province [92] 0 0
Czestochowa
Country [93] 0 0
Poland
State/province [93] 0 0
Jelenia Gora
Country [94] 0 0
Poland
State/province [94] 0 0
Kielce
Country [95] 0 0
Poland
State/province [95] 0 0
Kraków
Country [96] 0 0
Poland
State/province [96] 0 0
Lodz
Country [97] 0 0
Poland
State/province [97] 0 0
Nowy Targ
Country [98] 0 0
Poland
State/province [98] 0 0
Oswiecim
Country [99] 0 0
Poland
State/province [99] 0 0
Poznan
Country [100] 0 0
Poland
State/province [100] 0 0
Rzeszow
Country [101] 0 0
Poland
State/province [101] 0 0
Sopot
Country [102] 0 0
Poland
State/province [102] 0 0
Szczecin
Country [103] 0 0
Poland
State/province [103] 0 0
Warsaw
Country [104] 0 0
Poland
State/province [104] 0 0
Wroclaw
Country [105] 0 0
Poland
State/province [105] 0 0
Lódz
Country [106] 0 0
Poland
State/province [106] 0 0
Swidnica
Country [107] 0 0
Romania
State/province [107] 0 0
Bucuresti
Country [108] 0 0
Romania
State/province [108] 0 0
Cluj-Napoca
Country [109] 0 0
Romania
State/province [109] 0 0
Craiova
Country [110] 0 0
Romania
State/province [110] 0 0
Oradea
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Barnaul
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Izhevsk
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Nizhniy Novgorod
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Novosibirsk
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Saint Petersburg
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Saint-Peterburg
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Saint-Petersburg
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Samara
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Stavropol
Country [120] 0 0
Serbia
State/province [120] 0 0
Belgrade
Country [121] 0 0
Serbia
State/province [121] 0 0
Kragujevac
Country [122] 0 0
Serbia
State/province [122] 0 0
Sremska Mitrovica
Country [123] 0 0
Slovakia
State/province [123] 0 0
Presov
Country [124] 0 0
Slovakia
State/province [124] 0 0
Banska Bystrica
Country [125] 0 0
Slovakia
State/province [125] 0 0
Bardejov
Country [126] 0 0
Slovakia
State/province [126] 0 0
Nitra
Country [127] 0 0
Slovakia
State/province [127] 0 0
Nove Zamky
Country [128] 0 0
Slovakia
State/province [128] 0 0
Sahy
Country [129] 0 0
Slovakia
State/province [129] 0 0
Zilina
Country [130] 0 0
South Africa
State/province [130] 0 0
Centurion
Country [131] 0 0
South Africa
State/province [131] 0 0
Western Cape
Country [132] 0 0
Spain
State/province [132] 0 0
Alicante
Country [133] 0 0
Spain
State/province [133] 0 0
Madrid
Country [134] 0 0
Thailand
State/province [134] 0 0
Bangkok
Country [135] 0 0
Thailand
State/province [135] 0 0
Chiang Mai
Country [136] 0 0
Turkey
State/province [136] 0 0
Ankara
Country [137] 0 0
Turkey
State/province [137] 0 0
Kocaeli
Country [138] 0 0
Turkey
State/province [138] 0 0
Trabzon
Country [139] 0 0
Ukraine
State/province [139] 0 0
Dnipro
Country [140] 0 0
Ukraine
State/province [140] 0 0
Ivano-Frankivsk
Country [141] 0 0
Ukraine
State/province [141] 0 0
Kharkiv
Country [142] 0 0
Ukraine
State/province [142] 0 0
Kherson
Country [143] 0 0
Ukraine
State/province [143] 0 0
Kremenchuk
Country [144] 0 0
Ukraine
State/province [144] 0 0
Kyiv
Country [145] 0 0
Ukraine
State/province [145] 0 0
Lviv
Country [146] 0 0
Ukraine
State/province [146] 0 0
Odesa
Country [147] 0 0
Ukraine
State/province [147] 0 0
Uzhgorod
Country [148] 0 0
Ukraine
State/province [148] 0 0
Vinnytsia
Country [149] 0 0
Ukraine
State/province [149] 0 0
Zaporizhzhia
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Norfolk
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Somerset

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arena Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy
of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who
previously received double-blinded treatment (either etrasimod 2 mg per day or placebo)
during participation in one of two Phase 3 double-blinded, placebo-controlled studies (either
Study APD334-301 or APD334-302).
Trial website
https://clinicaltrials.gov/show/NCT03950232
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Cabell, MD
Address 0 0
Arena Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arena CT.gov Administrator
Address 0 0
Country 0 0
Phone 0 0
855-218-9153
Fax 0 0
Email 0 0
ct.gov@arenapharm.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03950232