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Progressive Multiple SclerosisPhase 3MAXIMSNCT05441488

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

A Phase 3 study testing Masitinib (4.5) in people with Progressive Multiple Sclerosis, run by AB Science at 37 sites in 8 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Progressive Multiple Sclerosis
What is being tested?
Masitinib (4.5)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
37 sitesin 8 countries
Study dates
28 Jun 2022to Dec 2028
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

37 sites in 8 countries.

37 sites in 8 countries

France9 sites

  • Service de Neurologie Hôpital Henri-Mondor

    Créteil

  • Hôpital Roger Salengro

    Lille

  • Hôpital Pasteur - CHU de Nice

    Nice

  • Centre Hospitalier Universitaire Nimes - Service de Neurologie

    Nîmes

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

    Poissy

  • Le Centre hospitalier universitaire de Poitiers

    Poitiers

  • Centre Hospitalier Universitaire de Rouen

    Rouen

  • Centre Hospitalier Universitaire de Strasbourg

    Strasbourg

  • Centre Hospitalier Universitaire Toulouse

    Toulouse

Other trials in France

Poland7 sites

  • Nzoz Neuro-Medic

    Katowice

  • NOVI-MED

    Ksawerów

  • Centrum Neurologii Krzysztof Selmaj

    Lodz

  • NZOZ Neuro-Med

    Lublin

  • Generała Jarosława Dąbrowskiego

    Oświęcim

  • NZOZ Neuro-Kard

    Poznan

  • Clinical Best Solutions

    Warsaw

Other trials in Poland

Greece5 sites

  • Athens Naval Hospital

    Athens

  • Eginition Hospital, Athens University Medical School

    Athens

  • General University Hospital of Larissa

    Larissa

  • AHEPA University Hospital, Aristotle University of Thessaloniki

    Thessaloniki

  • Private Clinic ELPIS

    Volos

Other trials in Greece

Spain5 sites

  • Hospital del Mar

    Barcelona

  • Hospital Universitario de Cruces

    Bilbao

  • Gregorio Marañón General University Hospital

    Madrid

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Universitario y Politécnico La Fe

    Valencia

Other trials in Spain

Russia4 sites

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

    Moscow

  • Perm Regional Clinical Hospital

    Perm

  • City Hospital No. 40 Kurortny District

    Saint Petersburg

  • LLC "Center of socially significant diseases"

    Saint Petersburg

Other trials in Russia

Ukraine4 sites

  • Lviv Regional Clinical Hospital

    Lviv

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

    Rivne

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

    Ternopil

  • Salutem Medical Center

    Vinnytsia

Other trials in Ukraine

Sweden2 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Centrum för neurologi

    Stockholm

Other trials in Sweden

Italy1 site

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

    Catania

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Placebo, Masitinib (4.5)
Keywords
Primary progressive MS, Non-active secondary progressive MS, Tyrosine kinase inhibitor, PPMS, SPMS
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Placebo Oral Tablet

    treatment per os

  • Masitinib (4.5)Drug

    Also called AB1010

    Masitinib (titration to 4.5 mg/kg/day)

Study groups in NCT05441488
Study groupRoleWhat they receive
Masitinib (4.5)ExperimentalParticipants 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.
Receives: Drug: Masitinib (4.5)
PlaceboPlacebo comparatorParticipants receive a matched dose placebo, given orally twice daily.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 96 weeks

Secondary outcomes (4)

  1. 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.

    Measured: 96 weeks

  2. 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.

    Measured: 96 weeks

  3. Brain Magnetic Resonance Imaging Assessments

    Change in baseline brain volume and lesions will be measured and assessed

    Measured: 96 weeks

  4. 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.

    Measured: 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start28 Jun 2022
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Why it stopped: The study has been suspended but may start again in the future.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05441488
Sponsor's protocol ID
AB20009; MAXIMS
Acronym
MAXIMS
Status last verified
Apr 2026
First submitted
28 Jun 2022
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 35190477

  • 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.

    PubMed 22691628

  • 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.

    PubMed 36048877

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Masitinib (4.5) in people with Progressive Multiple Sclerosis, run by AB Science at 37 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France, Poland, Greece, Spain, Russia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to confirmed progression (time frame: 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05441488, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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