Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
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.
Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of
 inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with
 c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. The objective
 of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus
 matched placebo in severe persistent asthma patients that is uncontrolled with oral
 corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over
 duration of the treatment.
Main inclusion criteria:

 1. Patient with severe asthma and already treated with oral corticosteroids at a minimal
 daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening
 visit

 2. Patient treated with oral corticosteroids during at least one period of 21 days, from
 1 year prior to screening to 3 months before screening

 3. Patient with no significant change in the regular asthma medication, no severe asthma
 exacerbation for at least 4 weeks prior to screening visit

 4. Non-smoker patient for at least 1 year and with a prior tobacco consumption < 10
 packs/year

 Main exclusion criteria:

 1. Patient with active lung disease other than asthma (e.g. chronic bronchitis)

 2. Female patient who is pregnant or lactating

 3. Asthmatic patient still exposed to allergens or to triggering factors influencing
 asthma control

 4. Patient with history of acute infectious sinusitis or respiratory tract infection
 within 4 weeks prior to screening visit