Masitinib in the treatment of patients with primary progressive or non-active secondary progressive multiple Sclerosis (MAXIMS)
Masitinib in the treatment of patients with primary progressive or non-active secondary progressive multiple Sclerosis (MAXIMS)
| Trial Fact Box | |
|---|---|
| NCT Code | NCT05441488 |
| Sponsor | AB Science |
| Study type(s) | Interventional |
| Phase | Phase 3 |
| Enrollment (Estimated) | 800 |
| Study Start (Actual) | 28 June 2022 |
| Primary Completion (Estimated) | December 2028 |
| Study Completion Date (Estimated) | December 2028 |
Official Title:
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
Brief 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.
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