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

Phase 3

Recruiting

• Conditions: Progressive Multiple Sclerosis
• Interventions: Drug: Masitinib (4.5); Drug: Placebo

• 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.

Study Timeline

• Study Start: 2022-06-28
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Primary Completion: 2025-12
• Study Completion: 2025-12

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

Group	Intervention	Description
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.
Placebo	Placebo	Participants receive a matched dose placebo, given orally twice daily.

Primary Outcome Measures

Name	Time	Method
Time to confirmed progression	96 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

Name	Time	Method
Time to Expanded Disability Status Scale (EDSS) score of 7.0	96 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)-54	96 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) Score	96 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 Assessments	96 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

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