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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02536404




Registration number
NCT02536404
Ethics application status
Date submitted
24/08/2015
Date registered
31/08/2015

Titles & IDs
Public title
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Scientific title
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
APD334-005
Universal Trial Number (UTN)
Trial acronym
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
Experimental: Etrasimod 2 mg -

Active comparator: Placebo -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to Week 48 (up to 30 days following discontinuation of the study drug)
Secondary outcome [1] 0 0
Proportion of Participants Who Achieved Clinical Response
Timepoint [1] 0 0
Week 46 (extension study APD334-005)
Secondary outcome [2] 0 0
Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005
Timepoint [2] 0 0
Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)
Secondary outcome [3] 0 0
Proportion of Participants Who Achieved Clinical Remission
Timepoint [3] 0 0
Week 46 (extension study APD334-005)
Secondary outcome [4] 0 0
Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005
Timepoint [4] 0 0
Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

Eligibility
Key inclusion criteria
* Participants who completed the APD334-003 (NCT02447302) study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who did not complete the APD334-003 study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2018
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Arena 1604 - Kingswood
Recruitment hospital [2] 0 0
Arena 1605 - Randwick
Recruitment hospital [3] 0 0
Arena 1607 - Subiaco
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
6008 - Subiaco
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
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Ohio
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United States of America
State/province [10] 0 0
Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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Wisconsin
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Belgium
State/province [18] 0 0
Edegem
Country [19] 0 0
Belgium
State/province [19] 0 0
Kortrijk
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Ruse
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Varna
Country [24] 0 0
Canada
State/province [24] 0 0
Manitoba
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Canada
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Nova Scotia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 4
Country [28] 0 0
France
State/province [28] 0 0
Amiens Cedex 1
Country [29] 0 0
France
State/province [29] 0 0
Clichy
Country [30] 0 0
France
State/province [30] 0 0
Lille Cedex 1443
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Pierre-Benite
Country [33] 0 0
France
State/province [33] 0 0
Saint-Etienne Cedex 1
Country [34] 0 0
France
State/province [34] 0 0
Vandoeuvre-les-Nancy
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Germany
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Hanover
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Germany
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Kiel
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Germany
State/province [38] 0 0
Leipzig
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Germany
State/province [39] 0 0
Oldenburg
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Germany
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Ulm
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Hungary
State/province [41] 0 0
Bekescsaba
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szombathely
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Israel
State/province [45] 0 0
Beer Sheva
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa
Country [47] 0 0
Israel
State/province [47] 0 0
Holon
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Israel
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Jerusalem
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Israel
State/province [49] 0 0
Petah-Tikva
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Gangwon-do
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Daegu
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Korea, Republic of
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Incheon
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Latvia
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Riga
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Lithuania
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Vilnius
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New Zealand
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Christchurch
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Poland
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Bydgoszcz
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Poland
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Elblag
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Kielce
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Krakow
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Lodz
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Poznan
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Poland
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Rzeszow
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Poland
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Sopot
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Poland
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Wroclaw
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Romania
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Bucharest
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Timisoara
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Novosibirsk
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Russian Federation
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Rostov-on-Don
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Russian Federation
State/province [72] 0 0
Saint Petersburg
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Russian Federation
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Samara
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pontevedra
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Spain
State/province [77] 0 0
Santiago de Compostela
Country [78] 0 0
Spain
State/province [78] 0 0
Sevilla
Country [79] 0 0
Ukraine
State/province [79] 0 0
Chernivtsi
Country [80] 0 0
Ukraine
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Ivano-Frankivsk
Country [81] 0 0
Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Odessa
Country [85] 0 0
Ukraine
State/province [85] 0 0
Uzhgorod
Country [86] 0 0
Ukraine
State/province [86] 0 0
Vinnytsia
Country [87] 0 0
Ukraine
State/province [87] 0 0
Vinnytsya
Country [88] 0 0
United Kingdom
State/province [88] 0 0
London
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Torquay
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arena CT.gov Administrator
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02536404