Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma

Study Overview
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Brief Summary
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The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010, administered at three dose levels during 4 months to patients with severe persistent corticosteroid dependent asthma, assessed on : the decrease in corticosteroid therapy the asthma control improvement (symptomatic scores, rescue medication intake, respiratory function) the pharmacokinetic profile of AB1010 clinical and biological safety parameters

Detailed Description
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This is a double-blind, placebo-controlled, randomized, parallel-groups, multicenter study of daily oral AB1010 at doses 3, 4.5 and 6 mg/kg/day. The study treatment is administered for 16 weeks: the first 4 weeks are a run-in period during which corticosteroids remain stable; during the following 8 weeks, corticosteroids are decreased every week until weaning or an exacerbation occurs; the last 4 weeks are a stabilization period. Patients have to perform a visit every 2 weeks during run-in, then every week for the following 3 months.

Official Title
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A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: AB1010
* Drug: AB1010
* Drug: AB1010
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition). Disease duration > 1 year. Stable disease with no exacerbation episode for at least one month before inclusion. Daily treated with 10 to 50 mg of equivalent prednisolone, with stable dosage since at least 3 months. Known reversibility of bronchial obstruction, defined as an enhancement of FEV1 ≥ 12%, 10 minutes after salbutamol administration, or 14 days after systemic treatment with 1 mg/kg/day of equivalent prednisolone. Exclusion Criteria: Asthmatic patients still exposed to allergens or to triggering factors influencing asthma control. History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>4,5 mg/kg/day | Drug: AB1010<br>* 4,5 mg/kg/day<br>* Other names: masitinib;|
| Experimental: 3<br>6 mg/kg/day | Drug: AB1010<br>* 6 mg/kg/day<br>* Other names: masitinib;|
| Placebo Comparator: 4<br>matching placebo for AB1010 3, 4,5 and 6 mg/kg/day | Drug: placebo<br>* matching placebo to AB1010 dosages<br>|
| Experimental: 1<br>AB1010 3 mg/kg/day | Drug: AB1010<br>* 3 mg/kg/day<br>* Other names: masitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in oral corticosteroid therapy (weaning extent) |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma control improvement |  | 16 weeks | 
| asthma exacerbation rate |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe asthma, corticosteroids dependent, asthma exacerbation, weaning, tyrosine kinase inhibitor, severe persistent corticosteroid dependent asthma