Back to resultsMasitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis (MAXIMS)
Primary Purpose
Progressive Multiple Sclerosis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Masitinib (4.5)
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Multiple Sclerosis focused on measuring Primary progressive MS, Non-active secondary progressive MS, Tyrosine kinase inhibitor, PPMS, SPMS
Eligibility 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
Sites / Locations
- Service de Neurologie Hôpital Henri-MondorRecruiting
- Hôpital Roger SalengroRecruiting
- Hôpital Pasteur - CHU de NiceRecruiting
- Centre Hospitalier Universitaire Nimes - Service de NeurologieRecruiting
- Centre hospitalier intercommunal de Poissy-Saint-Germain-en-LayeRecruiting
- Le Centre hospitalier universitaire de Poitiers
- Centre Hospitalier Universitaire de RouenRecruiting
- Centre Hospitalier Universitaire de StrasbourgRecruiting
- Centre Hospitalier Universitaire ToulouseRecruiting
- Athens Naval Hospital
- Eginition Hospital, Athens University Medical School
- General University Hospital of Larissa
- AHEPA University Hospital, Aristotle University of Thessaloniki
- Private Clinic ELPISRecruiting
- Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"
- Nzoz Neuro-MedicRecruiting
- NOVI-MEDRecruiting
- NZOZ Neuro-MedRecruiting
- Generała Jarosława DąbrowskiegoRecruiting
- NZOZ Neuro-KardRecruiting
- Clinical Best Solutions
- Centrum Neurologii Krzysztof SelmajRecruiting
- State Budgetary Institution of Health of the City of Moscow City Polyclinic #2Recruiting
- Perm Regional Clinical HospitalRecruiting
- City Hospital No. 40 Kurortny DistrictRecruiting
- LLC "Center of socially significant diseases"Recruiting
- Hospital del MarRecruiting
- Hospital Universitario de CrucesRecruiting
- Gregorio Marañón General University HospitalRecruiting
- Hospital Clínico San CarlosRecruiting
- Hospital Universitario y Politécnico La FeRecruiting
- Sahlgrenska University HospitalRecruiting
- Centrum för neurologiRecruiting
- Lviv Regional Clinical HospitalRecruiting
- Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal EnterpriseRecruiting
- Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1Recruiting
- Salutem Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Masitinib (4.5)
Placebo
Arm Description
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.
Participants receive a matched dose placebo, given orally twice daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Brain Magnetic Resonance Imaging Assessments
Change in baseline brain volume and lesions will be measured and assessed
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05441488
Brief Title
Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Multiple Sclerosis
Keywords
Primary progressive MS, Non-active secondary progressive MS, Tyrosine kinase inhibitor, PPMS, SPMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Masitinib (4.5)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a matched dose placebo, given orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Oral Tablet
Intervention Description
treatment per os
Intervention Type
Drug
Intervention Name(s)
Masitinib (4.5)
Other Intervention Name(s)
AB1010
Intervention Description
Masitinib (titration to 4.5 mg/kg/day)
Primary Outcome Measure Information:
Title
Time to confirmed progression
Description
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.
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Time to Expanded Disability Status Scale (EDSS) score of 7.0
Description
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.
Time Frame
96 weeks
Title
Overall Change in Expanded Disability Status Scale (EDSS) Score
Description
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.
Time Frame
96 weeks
Title
Brain Magnetic Resonance Imaging Assessments
Description
Change in baseline brain volume and lesions will be measured and assessed
Time Frame
96 weeks
Title
Multiple Sclerosis Quality of Life (MSQOL)-54
Description
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.
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Study Coordinator
Phone
+33(0)147200014
Email
clinical@ab-science.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick VERMERSCH, MD, PhD
Organizational Affiliation
University of Lille, CHU of Lille, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie Hôpital Henri-Mondor
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Roger Salengro
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Pasteur - CHU de Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Nimes - Service de Neurologie
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Name
Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye
City
Poissy
Country
France
Individual Site Status
Recruiting
Facility Name
Le Centre hospitalier universitaire de Poitiers
City
Poitiers
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Name
Athens Naval Hospital
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Eginition Hospital, Athens University Medical School
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
General University Hospital of Larissa
City
Larissa
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
AHEPA University Hospital, Aristotle University of Thessaloniki
City
Thessaloníki
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Private Clinic ELPIS
City
Volos
Country
Greece
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"
City
Catania
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Nzoz Neuro-Medic
City
Katowice
Country
Poland
Individual Site Status
Recruiting
Facility Name
NOVI-MED
City
Ksawerów
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Neuro-Med
City
Lublin
Country
Poland
Individual Site Status
Recruiting
Facility Name
Generała Jarosława Dąbrowskiego
City
Oświęcim
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Neuro-Kard
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Best Solutions
City
Warsaw
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Łódź
Country
Poland
Individual Site Status
Recruiting
Facility Name
State Budgetary Institution of Health of the City of Moscow City Polyclinic #2
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Perm Regional Clinical Hospital
City
Perm
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
City Hospital No. 40 Kurortny District
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
LLC "Center of socially significant diseases"
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Cruces
City
Bilbao
Country
Spain
Individual Site Status
Recruiting
Facility Name
Gregorio Marañón General University Hospital
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Centrum för neurologi
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal Enterprise
City
Rivne
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1
City
Ternopil
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Salutem Medical Center
City
Vinnytsia
Country
Ukraine
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
35190477
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.
Results Reference
background
PubMed Identifier
22691628
Citation
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.
Results Reference
background
PubMed Identifier
36048877
Citation
Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.
Results Reference
derived
Learn more about this trial
Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
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