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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02447302
Ethics application status
Date submitted
13/05/2015
Date registered
18/05/2015
Date last updated
15/02/2019

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
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo

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.


Treatment: Drugs: Etrasimod


Treatment: Drugs: Placebo


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

Outcomes
Primary outcome [1] 0 0
The effect of treatment with etrasimod (APD334) in improving the 3-component Mayo Clinic Score - The improvement of 3-component Mayo Clinic Score (score ranging from 0 to 9, including stool frequency, rectal bleeding and findings on endoscopy) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
The effect of treatment with etrasimod (APD334) on endoscopic improvement - The proportion of patients who achieve endoscopic improvement [defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of = 1 point] at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
The effect of treatment with etrasimod (APD334) in improving the 2-component Mayo Clinic Score - Improvement in 2-component Mayo score (score ranging from 0 to 6, including rectal bleeding and findings on endoscopy) at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
The effect of treatment with etrasimod (APD334) in improving the Total Mayo Clinic Score - Improvement in Total Mayo Clinic Score (score ranging from 0 to 12, including stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment) at Week 12.
Timepoint [3] 0 0
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
Gender
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 or 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
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)
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
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United States of America
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Illinois
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United States of America
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Michigan
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United States of America
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New York
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North Carolina
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Ohio
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United States of America
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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
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Austria
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Wien
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Belgium
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Edegem
Country [18] 0 0
Belgium
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Kortrijk
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Belgium
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Löwen
Country [20] 0 0
Bulgaria
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Ruse
Country [21] 0 0
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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Canada
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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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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Oldenburg
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Germany
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Ulm
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Hungary
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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
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Beer Sheva
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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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Korea, Republic of
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Busan
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-si
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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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Elblag
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Kielce
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Krakow
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Lodz
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Posen
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Rzeszow
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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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Kazan'
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Russian Federation
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Rostov on Don
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Russian Federation
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Ryazan'
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Russian Federation
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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
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Santiago de Compostela
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Spain
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Sevilla
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Ukraine
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Chernivtsi
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Ukraine
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Ivano-Frankivsk
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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
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Ukraine
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Uzhgorod
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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
State/province [89] 0 0
Wolverhampton

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 study is to determine whether etrasimod is a safe and effective treatment
for ulcerative colitis.
Trial website
https://clinicaltrials.gov/show/NCT02447302
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Summary results
Other publications