NCT05441488

Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis

A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.

Detailed description

Masitinib is a selective tyrosine kinase inhibitor, targeting innate immune cells (mast cells and microglia) that are involved in the pathophysiology of progressive multiple sclerosis (MS). This is a multicenter, double-blind, randomized, placebo-controlled, comparative study of oral masitinib in the treatment of patients with progressive MS who were progressing but not clinically active.

Conditions

• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Placebo	treatment per os
DRUG	Masitinib (4.5)	Masitinib (titration to 4.5 mg/kg/day)

Timeline

• Start date: 2022-06-28
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2022-07-01
• Last updated: 2025-09-12

Locations

37 sites across 8 countries: France, Greece, Italy, Poland, Russia, Spain, Sweden, Ukraine

Regulatory

• FDA-regulated drug study