SuspendedPhase 3
Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
Key facts
- Who runs it
- AB Science
- Where
- France, Greece, Italy, Poland, Russia, Spain, Sweden, and Ukraine37 sites in 8 countriesChoose a country to see its sites
- Trial code
- Status
- Suspended
- Phase
- Phase 3
- People taking part
- 800 people, planned
- Started
- 28 Jun 2022
- Expected to end
- Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- Masitinib (4.5)
- Record updated
- 6 May 2026
- Why it stopped
- The study has been suspended but may start again in the future.
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Other 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
This trial has no sites in United States.
It has sites in 8 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Masitinib (4.5)Treatment being tested
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.
- PlaceboPlacebo, for comparison
Participants receive a matched dose placebo, given orally twice daily.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 6 May 2026