A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse.

OngoingPhase 3Progressive MS2021-000639-30 ISRCTN93303620

What was tested

Masitinib
Fibroblast growth factor receptor 3 inhibitor|Platelet-derived growth factor receptor inhibitor|Stem cell growth factor receptor inhibitor
mansitinib

The primary endpoint is to assess the efficacy of masitinib 3.0 mg/kg/day with a dose escalation to 4.5 mg/kg/day after four weeks on the time to confirmed (12-weeks CDP) EDSS progression. Progression is defined as 1-point worsening when EDSS score ≤5.5, or 0.5-point worsening if baseline score >5.5.
Disability progression
Time to confirmed (12-weeks CDP [Confirmed Disability Progression]) Expanded Disability Status Scale (EDSS) progression. The EDSS progression is defined as 1-point worsening when EDSS baseline score ≤5.5 or 0.5 if baseline score >5.5 from randomization to Week 96.
Disability progression

The secondary endpoints of the study include the following:
1. Expanded Disability Status Scale (EDSS): 1.1. Time to confirmed (24-weeks CDP) EDSS progression. Progression is defined as 1-point worsening when EDSS score ≤5.5, or 0.5 if baseline score >5.5) 1.2. Expanded Disability Status Scale (EDSS): Absolute and ordinal change from baseline considering all measurements up to Week 96 2. Time to EDSS score of 7.0 Clinical Global Assessment Tools: 2.1. Time
Disability progressionRelapsesMRI lesionsBrain volume lossBlood or spinal fluid markersThinking and memoryFatigueWalking and mobilityArm and hand functionMood and sleepQuality of life (reported by participants)Safety

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