Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients

Sponsor
AB Science
Study ID
NCT07174492
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Masitinib 4.5 mg/kg/day — DRUG
    Masitinib (titration to 4.5 mg/kg/day)
  • Placebo — DRUG
    treatment per os
  • Riluzole (100 mg) — DRUG
    Riluzole 50 mg tablet, treatment per os

Study Details

The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Key Dates

Start date
Jan 1, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: masitinib + riluzole
    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 will be administered as an add-on to riluzole at 50 mg b.i.d
  • Placebo Comparator: placebo + riluzole
    Participants receive a matched dose placebo, given orally twice daily, in combination with riluzole at 50 mg b.i.d.

Primary Outcome Measure

ALSFRS-R [ Time Frame: 48 weeks ]

Central Contacts

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