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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Masitinib

• Registration Number: NCT03771040
• Lead Sponsor: AB Science

Brief Summary

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.

Detailed Description

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. This is a multicenter, double-blind, randomized, parallel-group (ascending dose titration of masitinib to 6.0 mg/kg/day and matching placebo), comparative study of oral masitinib in the treatment of patients with severe asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels. Eligible patients will be treated during at least 48 weeks.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Status Verified: 2020-04
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Disposition First Submitted: 2020-12-07
• Disposition First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Disposition First Posted: 2020-12-08
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receive matched placebo
Masitinib (titration to 6.0 mg/kg/day)	Masitinib	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.

Primary Outcome Measures

Name	Time	Method
Severe asthma exacerbation rate	Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months	The number of severe asthma exacerbations over time frame of outcome measure

Secondary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire (ACQ)	48 weeks	Asthma Control Questionnaire (ACQ); * Type of questionnaire-description: A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.; * Number of items: 7 items; 1 week recall (for items on symptoms and rescue inhaler use); * Number of domains \& categories: ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff; * Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Asthma exacerbation rate	Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months	The number of asthma exacerbations over time frame of outcome measure

Trial Locations

Locations (5)

Centro Respiratorio Quilmes; 🇦🇷 Buenos Aires, Argentina

Sarawak General Hospital; 🇲🇾 Kuching, Malaysia

Clínica Universidad de los Andes; 🇵🇪 Miraflores, Peru

The Philippine Heart Center; 🇵🇭 Quezon City, Philippines

National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine; 🇺🇦 Kiev, Ukraine