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®)

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®) - POINT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000541-12-DE

Enrollment

600

Registered

2016-07-06

Start date

2016-11-15

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing multiple sclerosis MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Ponesimod Product Code: ACT-128800 Pharmaceutical Form: Tablet INN or Proposed INN: Ponesimod Current Sponsor code: ACT-128800 Other descriptive name: PONESIMOD Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to determine whether add-on therapy with ponesimod reduces relapse frequency as compared to placebo in subjects with active RMS who are treated with DMF (Tecfidera®).;Secondary Objective: - To assess the effect of add-on therapy with ponesimod vs placebo on disability accumulation and on other aspects of MS disease control in subjects with RMS who are treated with DMF (Tecfidera®); - To assess the safety and tolerability of add-on therapy with ponesimod vs placebo in subjects with RMS who are treated with DMF (Tecfidera®).;Primary end point(s): Annualized relapse rate (ARR); defined as the number of confirmed relapses per subject-year.;Timepoint(s) of evaluation of this end point: From randomization up to end of study (EOS)	—

Measure

Time frame

Main Objective: The primary objective of the study is to determine whether add-on therapy with ponesimod reduces relapse frequency as compared to placebo in subjects with active RMS who are treated with DMF (Tecfidera®).;Secondary Objective: - To assess the effect of add-on therapy with ponesimod vs placebo on disability accumulation and on other aspects of MS disease control in subjects with RMS who are treated with DMF (Tecfidera®); - To assess the safety and tolerability of add-on therapy with ponesimod vs placebo in subjects with RMS who are treated with DMF (Tecfidera®).;Primary end point(s): Annualized relapse rate (ARR); defined as the number of confirmed relapses per subject-year.;Timepoint(s) of evaluation of this end point: From randomization up to end of study (EOS)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Time to 12-week confirmed disability accumulation (CDA) 2. Time to first confirmed relapse; up to EOS. 3. Mean number of combined unique active lesions (CUALs) per subject per post-baseline MRI scan; up to EOS. 4. Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ–RMS from baseline; up to EOS. 5. Longitudinal percent change over time in brain volume from baseline; up to EOS.;Timepoint(s) of evaluation of this end point: 1. From baseline up to EOS 2. From baseline up to EOS 3. From baseline up to EOS 4. From baseline up to EOS 5. From baseline up to EOS	—

Measure

Time frame

Secondary end point(s): 1. Time to 12-week confirmed disability accumulation (CDA) 2. Time to first confirmed relapse; up to EOS. 3. Mean number of combined unique active lesions (CUALs) per subject per post-baseline MRI scan; up to EOS. 4. Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ–RMS from baseline; up to EOS. 5. Longitudinal percent change over time in brain volume from baseline; up to EOS.;Timepoint(s) of evaluation of this end point: 1. From baseline up to EOS 2. From baseline up to EOS 3. From baseline up to EOS 4. From baseline up to EOS 5. From baseline up to EOS

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Countries

Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Poland, Portugal, Spain, United States

Contacts

Public ContactClinical Registry Group

Janssen Cilag International NV

ClinicalTrialsEU@its.jnj.com+3171 5242166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026