Back to resultsMasitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Severe persistent asthma, Eosinophil, Tyrosine kinase inhibitor
Eligibility Criteria
Main inclusion criteria include:
- 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
Main exclusion criteria include:
- 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)
Sites / Locations
- Centro Respiratorio Quilmes
- Sarawak General Hospital
- Clínica Universidad de los Andes
- The Philippine Heart Center
- National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Masitinib (titration to 6.0 mg/kg/day)
Placebo
Arm Description
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.
Participants receive matched placebo
Outcomes
Primary Outcome Measures
Severe asthma exacerbation rate
The number of severe asthma exacerbations over time frame of outcome measure
Secondary Outcome Measures
Asthma exacerbation rate
The number of asthma exacerbations over time frame of outcome measure
Asthma Control Questionnaire (ACQ)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771040
Brief Title
Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
Official Title
A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib Versus Placebo in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Severe persistent asthma, Eosinophil, Tyrosine kinase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib (titration to 6.0 mg/kg/day)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive matched placebo
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Severe asthma exacerbation rate
Description
The number of severe asthma exacerbations over time frame of outcome measure
Time Frame
Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
Secondary Outcome Measure Information:
Title
Asthma exacerbation rate
Description
The number of asthma exacerbations over time frame of outcome measure
Time Frame
Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
Title
Asthma Control Questionnaire (ACQ)
Description
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).
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion criteria include:
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
Main exclusion criteria include:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lavinia Davidescu, MD, PhD
Organizational Affiliation
University of Medicine and Pharmacy Oradea, Oradea, Romania.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Respiratorio Quilmes
City
Buenos Aires
Country
Argentina
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Clínica Universidad de los Andes
City
Miraflores
Country
Peru
Facility Name
The Philippine Heart Center
City
Quezon City
Country
Philippines
Facility Name
National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
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Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
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