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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02907177




Registration number
NCT02907177
Ethics application status
Date submitted
25/08/2016
Date registered
20/09/2016
Date last updated
18/05/2021

Titles & IDs
Public title
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Scientific title
Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Secondary ID [1] 0 0
AC-058B302
Universal Trial Number (UTN)
Trial acronym
POINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ponesimod
Other interventions - Placebo

Experimental: Ponesimod - Ponesimod

Placebo comparator: Placebo - Placebo


Treatment: Drugs: Ponesimod
One tablet of ponesimod 20 mg administered orally once daily in the morning from Day 15 to EOT. To reduce the first-dose effect of ponesimod, an uptitration scheme will be implemented from Day 1 to Day 14 (with dose strength increasing from 2 mg to 20 mg).

Other interventions: Placebo
One tablet of matching placebo administered orally once daily in the morning
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Confirmed Relapse Rate (ARR)
Timepoint [1] 0 0
Through study completion, an average of 68 weeks
Secondary outcome [1] 0 0
Percentage of Participants With 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate at Week 96
Timepoint [1] 0 0
Week 96
Secondary outcome [2] 0 0
Percentage of Participants Experiencing a Confirmed Relapse as Assessed by Kaplan Meier Estimate at Week 96
Timepoint [2] 0 0
Week 96
Secondary outcome [3] 0 0
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Timepoint [3] 0 0
Up to 147 Weeks

Eligibility
Key inclusion criteria
* Signed informed consent prior to initiation of any study-mandated procedure.
* Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception
* Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).
* Ongoing treatment with DMF for at least 6 months prior to screening
* Active disease after at least 3 months of DMF treatment
* Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Lactating or pregnant women and women intending to become pregnant during the study.
* Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).
* Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/03/2020
Sample size
Target
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Neuro-Immunology Clinical Research, Education and Support Service - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Pennsylvania
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Tennessee
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Texas
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Overpelt
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Bulgaria
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Sofia
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Canada
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Edmonton
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Czechia
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Brno
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Czechia
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Hradec Králové
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Czechia
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Jihlava
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Czechia
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Pardubice
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Teplice
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Aalborg
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Glostrup
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France
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Bobigny
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Clermont Ferrand
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Corbeil-Essonnes
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Dijon
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Lille
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Nancy
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Nimes
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Poissy
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Rennes
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France
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Rouen
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Germany
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Dresden
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Erfurt
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Giessen
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Hannover
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Leipzig
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Siegen
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Ulm
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Athens
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Marousi
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Bialystok
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Gdansk
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Lisboa
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Porto
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Krasnodar
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Moscow
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Barcelona
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El Palmar
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Madrid
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Salt
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Spain
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Santiago de Compostela
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Sevilla
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Switzerland
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Basel
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Switzerland
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Lugano
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United Kingdom
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London
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Oxford
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Sheffield
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Stoke-on-Trent

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

Ethics approval
Ethics application status

Summary
Brief summary
This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
Trial website
https://clinicaltrials.gov/study/NCT02907177
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tatiana Scherz, MD, PhD
Address 0 0
Actelion
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02907177