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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02447302




Registration number
NCT02447302
Ethics application status
Date submitted
13/05/2015
Date registered
18/05/2015

Titles & IDs
Public title
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
2015-001942-28
Secondary ID [2] 0 0
APD334-003
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 Low Dose - Oral, low dose, daily for 12 Weeks

Experimental: Etrasimod High Dose - Oral, high dose, daily for 12 weeks

Placebo comparator: Placebo - Oral, placebo, daily for 12 weeks.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Adapted Mayo Score (MCS) at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change From Baseline in 2-component MCS at Week 12
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Change From Baseline in Total Mayo Score (TMS) at Week 12
Timepoint [3] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
* Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
* Evidence of colonic ulcerative colitis activity on endoscopy
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
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
15/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/02/2018
Sample size
Target
Accrual to date
Final
156
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
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Florida
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United States of America
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Illinois
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Michigan
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Austria
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Wien
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Belgium
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Edegem
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Belgium
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Kortrijk
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Belgium
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Löwen
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
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Manitoba
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Canada
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Nova Scotia
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Ontario
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Czechia
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Praha 4
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France
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Amiens Cedex 1
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France
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Clichy
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France
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Lille Cedex 1443
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France
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Paris
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France
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Pierre-Benite
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France
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Saint-Etienne Cedex 1
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France
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Vandoeuvre-les-Nancy
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Germany
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Hamburg
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Germany
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Hanover
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Kiel
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Leipzig
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Oldenburg
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Ulm
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Bekescsaba
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Budapest
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Debrecen
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Szombathely
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Petah-Tikva
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Busan
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Incheon
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Seoul
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Suwon-si
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Wonju
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Riga
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Iasi
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Timisoara
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Kazan'
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Krasnoyarsk
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Rostov on Don
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Saint Petersburg
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Samara
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Barcelona
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Pontevedra
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Sevilla
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Ukraine
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Chernivtsi
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Ivano-Frankivsk
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Ukraine
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Kharkov
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Kiev
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Odessa
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Uzhgorod
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Ukraine
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Vinnytsia
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Ukraine
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Vinnytsya
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United Kingdom
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London
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United Kingdom
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Torquay
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United Kingdom
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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/NCT02447302