Stopped earlyPhase 3Relapsing and progressiveNCT029071772012-000541-12

What it found

Stopped early

The trial ended early for another reason (see below).

annualized relapse rate (ARR) at end-of-study (EOS)

rate ratio 1.2

p = 0.5252

Total participants: 136

Read by software from the paper's abstract

Reason given: sponsor decision due to low recruitment

What was tested

Treatment tested

  • Ponesimod

    Sphingosine 1-phosphate receptor Edg-1 agonist

Placebo or sham

  • Placebo

Results by group

Annualized Confirmed Relapse Rate (ARR)

Through study completion, an average of 68 weeks

GroupValueIntervalNumber analysed
Ponesimod Plus Dimethyl Fumarate (DMF)0.237 Relapses per year0.144–0.39166
Placebo Plus Dimethyl Fumarate (DMF)0.187 Relapses per year0.109–0.32267

Ponesimod Plus Dimethyl Fumarate (DMF)

0.237

Placebo Plus Dimethyl Fumarate (DMF)

0.187

p = 0.5252; Treatment effect (rate ratio) 1.270 (95% CI 0.608–2.654)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Ponesimod Plus Dimethyl Fumarate (DMF)676 (9.0%)0
Placebo Plus Dimethyl Fumarate (DMF)687 (10.3%)1

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Annualized Confirmed Relapse Rate (ARR)

    Through study completion, an average of 68 weeks

    Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual function
  • Annualized relapse rate (ARR); defined as the number of confirmed relapses per subject-year.

    Relapses

Other measures (4)

  • Percentage of Participants With 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate at Week 96

    Week 96

    Disability progression
  • Percentage of Participants Experiencing a Confirmed Relapse as Assessed by Kaplan Meier Estimate at Week 96

    Week 96

    Relapses
  • Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

    Up to 147 Weeks

    Safety
  • 1. Time to 12-week confirmed disability accumulation (CDA)

    Disability progression

Who could take part

Relapsing and progressive · 18 to 55

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). 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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®).

Papers

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Related trials

History

    1. Started

      Mar 2017

    2. Main results due

      Mar 2020

    3. Finished

      Mar 2020

    4. Results posted

      May 2021

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