Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels

Sponsor
AB Science
Study ID
NCT03771040
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels.

Key Dates

Start date
Dec 31, 2016
Status verified
Apr 2020
Primary completion
Sep 30, 2020
Completion
Sep 30, 2020

Study Design

Enrollment
347 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib (titration to 6.0 mg/kg/day)
    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, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control.
  • Placebo Comparator: Placebo
    Participants receive matched placebo

Primary Outcome Measure

Severe asthma exacerbation rate [ Time Frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months ]

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