MedPath

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

Phase 3
Recruiting
Conditions
Progressive Multiple Sclerosis
Interventions
Registration Number
NCT05441488
Lead Sponsor
AB Science
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
800
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Masitinib (4.5)Masitinib (4.5)Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control.
PlaceboPlaceboParticipants receive a matched dose placebo, given orally twice daily.
Primary Outcome Measures
NameTimeMethod
Time to confirmed progression96 weeks

Time to disability progression, confirmed by two consecutive visits, wherein progression of disability is measured by the Expanded Disability Status Scale (EDSS) with progression defined as a 1-point worsening for baseline EDSS score ≤5.5, or 0.5-point worsening for baseline EDSS score \>5.5.

The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS provides a total score on a scale that ranges from 0 to 10, in 0.5-point increments, with higher scores indicating greater disability. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.

Secondary Outcome Measures
NameTimeMethod
Time to Expanded Disability Status Scale (EDSS) score of 7.096 weeks

Time to reach EDSS score of 7 from baseline up to week 96, wherein EDSS score of ≥7.0 represents wheelchair dependency.

The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS provides a total score on a scale that ranges from 0 to 10, in 0.5-point increments, with higher scores indicating greater disability. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.

Multiple Sclerosis Quality of Life (MSQOL)-5496 weeks

Change in quality of life assessment instrument MSQOL-54 The MS Quality of Life Instrument (MSQoL-54) is a structured self-report questionnaire that is used to assess the impact of MS on the individual's well-being. It consists of 52 items combined in 12 subscales, and two single items. Higher scores indicate a better quality of life.

Overall Change in Expanded Disability Status Scale (EDSS) Score96 weeks

Change from baseline on the EDSS, calculated using repeated measures methodology on all time points measured over 96 weeks (i.e., a population-averaged score comprising consecutive data points from each patient).

The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS provides a total score on a scale that ranges from 0 to 10, in 0.5-point increments, with higher scores indicating greater disability. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.

Brain Magnetic Resonance Imaging Assessments96 weeks

Change in baseline brain volume and lesions will be measured and assessed

Trial Locations

Locations (37)

Service de Neurologie Hôpital Henri-Mondor

🇫🇷

Créteil, France

Hôpital Roger Salengro

🇫🇷

Lille, France

Hôpital Pasteur - CHU de Nice

🇫🇷

Nice, France

Centre Hospitalier Universitaire Nimes - Service de Neurologie

🇫🇷

Nîmes, France

Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye

🇫🇷

Poissy, France

Le Centre hospitalier universitaire de Poitiers

🇫🇷

Poitiers, France

Centre Hospitalier Universitaire de Rouen

🇫🇷

Rouen, France

Centre Hospitalier Universitaire de Strasbourg

🇫🇷

Strasbourg, France

Centre Hospitalier Universitaire Toulouse

🇫🇷

Toulouse, France

Athens Naval Hospital

🇬🇷

Athens, Greece

Scroll for more (27 remaining)
Service de Neurologie Hôpital Henri-Mondor
🇫🇷Créteil, France

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.