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

Sponsor
AB Science
Study ID
NCT05441488
Phase
PHASE3
Status
Suspended

Conditions

  • Progressive Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    treatment per os
  • Masitinib (4.5) — DRUG
    Masitinib (titration to 4.5 mg/kg/day)

Study Details

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.

Key Dates

Start date
Jun 28, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Placebo Comparator: Placebo
    Participants receive a matched dose placebo, given orally twice daily.

Primary Outcome Measure

Time to confirmed progression [ Time Frame: 96 weeks ]

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