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

NCT05441488 | Suspended Phase 3 DMC FDA Drug

• 1 other identifier: AB20009; MAXIMS
• Study Type: interventional
• Target: 800
• Locations: 8 countries
• Sites: 37

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.

Conditions

Progressive Multiple Sclerosis

Keywords

Primary progressive MS; Non-active secondary progressive MS; Tyrosine kinase inhibitor; PPMS; SPMS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to Expanded Disability Status Scale (EDSS) score of 7.0

  96 weeks

• Overall Change in Expanded Disability Status Scale (EDSS) Score

  96 weeks

• Brain Magnetic Resonance Imaging Assessments

  96 weeks

• Multiple Sclerosis Quality of Life (MSQOL)-54

  96 weeks

Study Arms (2)

Masitinib (4.5)

EXPERIMENTAL

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.

Drug: Masitinib (4.5)

Placebo

PLACEBO COMPARATOR

Participants receive a matched dose placebo, given orally twice daily.

Drug: Placebo

Interventions

Placebo DRUG

treatment per os

Also known as: Placebo Oral Tablet

Placebo

Masitinib (4.5) DRUG

Masitinib (titration to 4.5 mg/kg/day)

Also known as: AB1010

Masitinib (4.5)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AB Science: lead

Study Sites (37)

Service de Neurologie Hôpital Henri-Mondor

Créteil, France

Location

Hôpital Roger Salengro

Lille, France

Location

Hôpital Pasteur - CHU de Nice

Nice, France

Location

Centre Hospitalier Universitaire Nimes - Service de Neurologie

Nîmes, France

Location

Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye

Poissy, France

Location

Le Centre hospitalier universitaire de Poitiers

Poitiers, France

Location

Centre Hospitalier Universitaire de Rouen

Rouen, France

Location

Centre Hospitalier Universitaire de Strasbourg

Strasbourg, France

Location

Centre Hospitalier Universitaire Toulouse

Toulouse, France

Location

Athens Naval Hospital

Athens, Greece

Location

Eginition Hospital, Athens University Medical School

Athens, Greece

Location

General University Hospital of Larissa

Larissa, Greece

Location

AHEPA University Hospital, Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

Private Clinic ELPIS

Volos, Greece

Location

Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"

Catania, Italy

Location

Nzoz Neuro-Medic

Katowice, Poland

Location

NOVI-MED

Ksawerów, Poland

Location

Centrum Neurologii Krzysztof Selmaj

Lodz, Poland

Location

NZOZ Neuro-Med

Lublin, Poland

Location

Generała Jarosława Dąbrowskiego

Oświęcim, Poland

Location

NZOZ Neuro-Kard

Poznan, Poland

Location

Clinical Best Solutions

Warsaw, Poland

Location

State Budgetary Institution of Health of the City of Moscow City Polyclinic #2

Moscow, Russia

Location

Perm Regional Clinical Hospital

Perm, Russia

Location

City Hospital No. 40 Kurortny District

Saint Petersburg, Russia

Location

LLC "Center of socially significant diseases"

Saint Petersburg, Russia

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario de Cruces

Bilbao, Spain

Location

Gregorio Marañón General University Hospital

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Centrum för neurologi

Stockholm, Sweden

Location

Lviv Regional Clinical Hospital

Lviv, Ukraine

Location

Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal Enterprise

Rivne, Ukraine

Location

Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1

Ternopil, Ukraine

Location

Salutem Medical Center

Vinnytsia, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 35190477 BACKGROUND

• 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.

  PMID: 22691628 BACKGROUND

• 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.

  PMID: 36048877 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

masitinib

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick VERMERSCH, MD, PhD

  University of Lille, CHU of Lille, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: June 28, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

IT (1); ES (5); GR (5); UA (4); RU (4); SE (2); PL (7); FR (9)