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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Masitinib as add-on to oral corticosteroids

Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids

Group Type EXPERIMENTAL

Masitinib

Intervention Type DRUG

6 mg/kg/day

Placebo as add-on to oral corticosteroids

Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Masitinib

6 mg/kg/day

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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AB1010 Placebo Oral Tablet

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No