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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02907177
Ethics application status
Date submitted
25/08/2016
Date registered
20/09/2016
Date last updated
10/07/2019

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 relapse rate (ARR) - Number of confirmed relapses per subject-year
Timepoint [1] 0 0
From randomization up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years
Secondary outcome [1] 0 0
Time to 12-week confirmed disability accumulation (CDA) - Time to 12-week confirmed disability accumulation (CDA)
Timepoint [1] 0 0
From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years
Secondary outcome [2] 0 0
Time to first confirmed relapse - Time to first confirmed relapse
Timepoint [2] 0 0
From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years
Secondary outcome [3] 0 0
Mean number of combined unique active lesions (CUALs) per post-baseline scan - Mean number of combined unique active lesions (CUALs) per post-baseline scan
Timepoint [3] 0 0
From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years
Secondary outcome [4] 0 0
Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS - Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS
Timepoint [4] 0 0
From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years
Secondary outcome [5] 0 0
Longitudinal percent change from baseline over time in brain volume - Longitudinal percent change from baseline over time in brain volume
Timepoint [5] 0 0
From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years

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
Gender
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
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)
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
Country [1] 0 0
United States of America
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Alabama
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California
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Colorado
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Connecticut
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Florida
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Indiana
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Kansas
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Michigan
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New Mexico
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New York
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Ohio
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Oklahoma
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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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Gent
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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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Pardubice
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Teplice
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Aalborg
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Glostrup
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Tampere
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Finland
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Turku
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France
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Bobigny
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France
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Clermont Ferrand
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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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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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Greifswald
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Hannover
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Leipzig
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Siegen
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Ulm
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Pozzilli
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Roma
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Siena
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DF
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Jalisco
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Monterrey
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Bialystok
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Gdansk
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Katowice
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Ksawerów
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Amadora
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Portugal
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Porto
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Chelyabinsk
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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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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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Bristol
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London
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Newcastle
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Nottingham
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Oxford
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Sheffield
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United Kingdom
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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/show/NCT02907177
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
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

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