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

NCT03771040 | Completed Phase 3 FDA Drug

• 1 other identifier: AB14001
• Study Type: interventional
• Target: 347
• Locations: 5 countries
• Sites: 5

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.

Conditions

Asthma

Keywords

Severe persistent asthma; Eosinophil; Tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Severe asthma exacerbation rate

  The number of severe asthma exacerbations over time frame of outcome measure

  Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months

Secondary Outcomes (2)

• Asthma exacerbation rate

  Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months

• Asthma Control Questionnaire (ACQ)

  48 weeks

Study Arms (2)

Masitinib (titration to 6.0 mg/kg/day)

EXPERIMENTAL

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.

Drug: Masitinib

Placebo

PLACEBO COMPARATOR

Participants receive matched placebo

Drug: Placebo

Interventions

Masitinib DRUG

Also known as: AB1010

Masitinib (titration to 6.0 mg/kg/day)

Placebo DRUG

Also known as: Placebo Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AB Science: lead

Study Sites (5)

Centro Respiratorio Quilmes

Buenos Aires, Argentina

Location

Sarawak General Hospital

Kuching, 93586, Malaysia

Location

Clínica Universidad de los Andes

Miraflores, Peru

Location

The Philippine Heart Center

Quezon City, Philippines

Location

National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine

Kiev, 03680, Ukraine

Location

MeSH Terms

Conditions

Asthma

Interventions

masitinib

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lavinia Davidescu, MD, PhD

  University of Medicine and Pharmacy Oradea, Oradea, Romania.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 10, 2018
• Study Start: December 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1); MY (1); PE (1); AR (1); UA (1)