Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

Phase 3 Completed 656 enrolled AB Science

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

Timeline

Start: 2011-08
Primary completion: 2019-09
Completion: 2020-02

Outcome

Met primary endpoint

paper showed significant benefit over placebo (n = 101) according to the primary end point, 0.001 vs 0.098, respectively PMID 35190477 ↗

paper with a between-group difference of -0.097 (97% CI -0.192 to -0.002); p = 0.0256. PMID 35190477 ↗

Publications

Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Masitinib	Small molecule	4.5 mg/kg	Oral
Subject	Masitinib	Small molecule	6 mg/kg	Oral