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Trial record 1 of 3 for:    Masitinib | multiple sclerosis
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Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis (MAXIMS)

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ClinicalTrials.gov Identifier: NCT05441488
Recruitment Status : Recruiting
First Posted : July 1, 2022
Last Update Posted : March 30, 2023
Sponsor:
Information provided by (Responsible Party):
AB Science

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.

Condition or disease Intervention/treatment Phase
Progressive Multiple Sclerosis Drug: Placebo Drug: Masitinib (4.5) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 28, 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025


Arm Intervention/treatment
Experimental: 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.
Drug: Masitinib (4.5)
Masitinib (titration to 4.5 mg/kg/day)
Other Name: AB1010

Placebo Comparator: Placebo
Participants receive a matched dose placebo, given orally twice daily.
Drug: Placebo
treatment per os
Other Name: Placebo Oral Tablet




Primary Outcome Measures :
  1. Time to confirmed progression [ Time Frame: 96 weeks ]

    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 :
  1. Time to Expanded Disability Status Scale (EDSS) score of 7.0 [ Time Frame: 96 weeks ]

    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.


  2. Overall Change in Expanded Disability Status Scale (EDSS) Score [ Time Frame: 96 weeks ]

    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.


  3. Brain Magnetic Resonance Imaging Assessments [ Time Frame: 96 weeks ]
    Change in baseline brain volume and lesions will be measured and assessed

  4. Multiple Sclerosis Quality of Life (MSQOL)-54 [ Time Frame: 96 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05441488


Contacts
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Contact: Clinical Study Coordinator +33(0)147200014 clinical@ab-science.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Patrick VERMERSCH, MD, PhD University of Lille, CHU of Lille, France
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT05441488    
Other Study ID Numbers: AB20009; MAXIMS
First Posted: July 1, 2022    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AB Science:
Primary progressive MS
Non-active secondary progressive MS
Tyrosine kinase inhibitor
PPMS
SPMS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes