Status:
ACTIVE_NOT_RECRUITING
Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
Lead Sponsor:
AB Science
Conditions:
Progressive Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05441488
Start Date
June 28 2022
End Date
December 1 2028
Last Update
September 12 2025
Active Locations (37)
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1
Service de Neurologie Hôpital Henri-Mondor
Créteil, France
2
Hôpital Roger Salengro
Lille, France
3
Hôpital Pasteur - CHU de Nice
Nice, France
4
Centre Hospitalier Universitaire Nimes - Service de Neurologie
Nîmes, France