Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

Sponsor
AB Science
Study ID
NCT01449162
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Masitinib — DRUG
    6 mg/kg/day
  • Placebo — DRUG

Study Details

The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

Key Dates

Start date
Jan 31, 2011
Status verified
Feb 2021
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019

Study Design

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

Arms

  • Experimental: Masitinib as add-on to oral corticosteroids
    Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
  • Placebo Comparator: Placebo as add-on to oral corticosteroids
    Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids

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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