Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
NCT ID: NCT05441488
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2022-06-28
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Masitinib (4.5)
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.
Masitinib (4.5)
Masitinib (titration to 4.5 mg/kg/day)
Placebo
Participants receive a matched dose placebo, given orally twice daily.
Placebo
treatment per os
Interventions
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Placebo
treatment per os
Masitinib (4.5)
Masitinib (titration to 4.5 mg/kg/day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick VERMERSCH, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Lille, CHU of Lille, France
Locations
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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, , France
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
Thessaloniki, , Greece
Private Clinic ELPIS
Volos, , Greece
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"
Catania, , Italy
Nzoz Neuro-Medic
Katowice, , Poland
NOVI-MED
Ksawerów, , Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, , Poland
NZOZ Neuro-Med
Lublin, , Poland
Generała Jarosława Dąbrowskiego
Oświęcim, , Poland
NZOZ Neuro-Kard
Poznan, , Poland
Clinical Best Solutions
Warsaw, , Poland
State Budgetary Institution of Health of the City of Moscow City Polyclinic #2
Moscow, , Russia
Perm Regional Clinical Hospital
Perm, , Russia
City Hospital No. 40 Kurortny District
Saint Petersburg, , Russia
LLC "Center of socially significant diseases"
Saint Petersburg, , Russia
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, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Centrum för neurologi
Stockholm, , Sweden
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, , Ukraine
Countries
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References
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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.
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.
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.
Other Identifiers
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AB20009; MAXIMS
Identifier Type: -
Identifier Source: org_study_id
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