POINT
What it found
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod Plus Dimethyl Fumarate (DMF) | 0.237 Relapses per year | 0.144–0.391 | 66 |
| Placebo Plus Dimethyl Fumarate (DMF) | 0.187 Relapses per year | 0.109–0.322 | 67 |
Ponesimod Plus Dimethyl Fumarate (DMF)
Placebo Plus Dimethyl Fumarate (DMF)
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
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ponesimod Plus Dimethyl Fumarate (DMF) | 67 | 6 (9.0%) | 0 |
| Placebo Plus Dimethyl Fumarate (DMF) | 68 | 7 (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 functionAnnualized 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 progressionPercentage of Participants Experiencing a Confirmed Relapse as Assessed by Kaplan Meier Estimate at Week 96
Week 96
RelapsesNumber of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to 147 Weeks
Safety1. 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
Results
Ponesimod as add-on treatment in patients with active relapsing multiple sclerosis under dimethyl fumarate (POINT): A phase 3, randomized, placebo-controlled clinical trial.Mult Scler Relat Disord · 2025
Primary endpoint (ARR) was not met (rate ratio, ponesimod+DMF versus placebo+DMF: 1.2; p = 0.5252).
Read by software from the paper's abstract
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History
Started
Mar 2017
Main results due
Mar 2020
Finished
Mar 2020
Results posted
May 2021
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