Masitinib in Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis
Research type
Research Study
Full title
A 96-week, prospective, multicenter, randomised, double-blind, placebocontrolled, 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.
IRAS ID
1005160
Contact name
Maria Carvalho
Contact email
Sponsor organisation
AB Science
Eudract number
2021-000639-30
ISRCTN Number
ISRCTN93303620
Research summary
Multiple sclerosis (MS) is an inflammatory neurodegenerative disease of the central nervous system (CNS). The vast majority of MS drugs primarily benefit active/relapsing forms of MS with limited efficacy in the progressive forms. It is estimated that 10-15,000 people have primary progressive MS in the UK.
Masitinib is a new chemical entity under development in progressive forms of multiple sclerosis. Masitinib targets newly discovered disease mechanism via its dual action against activated macrophage/microglia and mast cells.
Patients with primary and secondary progressive MS without relapse will be eligible to be treated during the study. Patients will be treated for 96 weeks with masitinib or placebo. They will be then offered option to participate in open label extension.
As part of the study patients will have physical exam, vital signs, neurological exam. They will have efficacy assessments and questionnaires to evaluate their medical condition and its progress. Patients will have ECGs to monitor cardiac safety and also routine blood samples and PK blood samples. There will be urinalysis and urine cytology. Some patients there will be regular permanency testing.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0092
Date of REC Opinion
20 May 2022
REC opinion
Further Information Favourable Opinion