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Using masitinib to treat progressive multiple sclerosis

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

Phase 3 Interventional AB Science · NCT05441488

This study is testing if a new oral medication called masitinib can help slow down the progression of multiple sclerosis in patients who haven't had a relapse for at least two years.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment800 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAB Science Industry-sponsored
Drugs / interventionsmasitinib
Locations37 sites (Créteil and 36 other locations)
Trial IDNCT05441488 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of oral masitinib compared to a placebo in patients with primary progressive or non-active secondary progressive multiple sclerosis. The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial, focusing on patients who have not experienced a relapse for at least two years. Masitinib is a selective tyrosine kinase inhibitor that targets immune cells involved in the progression of multiple sclerosis. The trial aims to determine whether masitinib can slow disease progression in these patients.

Who should consider this trial

Good fit: Ideal candidates include patients with primary progressive or non-active secondary progressive multiple sclerosis who have not had a relapse for at least two years and have specific EDSS scores.

Not a fit: Patients with other neurological diseases that could explain their symptoms or those who have had recent relapses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with progressive forms of multiple sclerosis, potentially slowing disease progression.

How similar studies have performed: Other studies have explored treatments for progressive multiple sclerosis, but the specific use of masitinib in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Main inclusion criteria include:

* Patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before baseline and with no relapse diagnosed according to the 2017 revised McDonald's criteria at least two years before screening
* Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline
* Patients with an EDSS score progression ≥1 point with no improvement during 2 years
* Absence of T1 Gadolinium-enhancing brain lesions as measured by MRI at screening

Main exclusion criteria include:

* Patients suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions observed at screening
* Inability to complete screening MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic
* Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline
* Patients with lymphocytes \<1.0 × 10\^9/L at screening and at baseline

Where this trial is running

Créteil and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Progressive Multiple SclerosisPrimary progressive MSNon-active secondary progressive MSTyrosine kinase inhibitorPPMSSPMS
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.