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

NCT ID: NCT03771040

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-09-30

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.

Conditions

Asthma

Keywords

Severe persistent asthma; Eosinophil; Tyrosine kinase inhibitor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Masitinib (titration to 6.0 mg/kg/day)

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.

Group Type: EXPERIMENTAL

Masitinib

Intervention Type: DRUG

Placebo

Participants receive matched placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Masitinib

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

AB1010; Placebo Oral Tablet

Eligibility Criteria

Inclusion Criteria

• Patients with a physician diagnosis of persistent asthma for at least 12 months based on Global Initiative for Asthma (GINA) 2009 Guidelines whose asthma is partially controlled or uncontrolled on inhaled corticosteroids (ICS) / long-acting beta2-agonists (LABA) combination therapy.
• Patient with elevated eosinophil level related to asthma at baseline: ≥0.15 K/uL or patient with eosinophil level ≥0.15 K/uL related to asthma demonstrated in the year prior to screening
• Non-smoker patient for at least one year and with a prior tobacco consumption <10 packs/year

Exclusion Criteria

• Female patient who is pregnant or lactating
• Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
• Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests
• Within 12 weeks prior to screening, patient who received oral corticosteroids for any other reason than to treat severe asthma exacerbation (patients needing long term corticosteroids intake to control basal asthma condition)
• Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
• Patient with active lung disease other than asthma (e.g. chronic bronchitis)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AB Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lavinia Davidescu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy Oradea, Oradea, Romania.

Locations

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

Countries

Hungary; Argentina; Malaysia; Peru; Philippines; Ukraine

Other Identifiers

AB14001

Identifier Type: -

Identifier Source: org_study_id