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

Progressive Multiple Sclerosis Clinical Trial

— MAXIMS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441488
• Other study ID #: AB20009; MAXIMS
• Status: Recruiting
• Phase: Phase 3
• Start date: June 28, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: AB Science
• Contact: Clinical Study Coordinator
• Phone: +33(0)147200014
• Email: clinical[@]ab-science.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Progressive Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Placebo
treatment per os
• Masitinib (4.5)
Masitinib (titration to 4.5 mg/kg/day)

Locations

Country	Name	City	State
France	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
Greece	Athens Naval Hospital	Athens
Greece	Eginition Hospital, Athens University Medical School	Athens
Greece	General University Hospital of Larissa	Larissa
Greece	AHEPA University Hospital, Aristotle University of Thessaloniki	Thessaloníki
Greece	Private Clinic ELPIS	Volos
Italy	Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"	Catania
Poland	Nzoz Neuro-Medic	Katowice
Poland	NOVI-MED	Ksawerów
Poland	Centrum Neurologii Krzysztof Selmaj	Lódz
Poland	NZOZ Neuro-Med	Lublin
Poland	Generala Jaroslawa Dabrowskiego	Oswiecim
Poland	NZOZ Neuro-Kard	Poznan
Poland	Clinical Best Solutions	Warsaw
Russian Federation	State Budgetary Institution of Health of the City of Moscow City Polyclinic #2	Moscow
Russian Federation	Perm Regional Clinical Hospital	Perm
Russian Federation	City Hospital No. 40 Kurortny District	Saint Petersburg
Russian Federation	LLC "Center of socially significant diseases"	Saint Petersburg
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario de Cruces	Bilbao
Spain	Gregorio Marañón General University Hospital	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Centrum för neurologi	Stockholm
Ukraine	Lviv Regional Clinical Hospital	Lviv
Ukraine	Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal Enterprise	Rivne
Ukraine	Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1	Ternopil
Ukraine	Salutem Medical Center	Vinnytsia

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

France,  Greece,  Italy,  Poland,  Russian Federation,  Spain,  Sweden,  Ukraine, 

References & Publications (2)

Vermersch P, Benrabah R, Schmidt N, Zephir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36. — View Citation

Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to confirmed progression	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.	96 weeks
Secondary	Time to Expanded Disability Status Scale (EDSS) score of 7.0	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.	96 weeks
Secondary	Overall Change in Expanded Disability Status Scale (EDSS) Score	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.	96 weeks
Secondary	Brain Magnetic Resonance Imaging Assessments	Change in baseline brain volume and lesions will be measured and assessed	96 weeks
Secondary	Multiple Sclerosis Quality of Life (MSQOL)-54	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.	96 weeks