Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib at 6 mg/kg/Day Versus Placebo in the Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Masitinib

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. The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria, 5800
    • Dr. Georgi Stranski University Hospital
• Czechia
  • Mělník, Czechia
    • Hospital Polyclinic Melnik
• France
  • Brest, France, 29609
    • Hospital La Cavale Blanche
  • Lille, France
    • l'Hopital Albert Calmette
  • Lyon, France, 69317
    • l'Hopital de la Croix Rousse
• Hungary
  • Debrecen, Hungary, 4032
    • University of Debrecen Medical and Health Science Center
• India
  • Hyderabad, India, 500068
    • King George Hospital
• Spain
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main inclusion criteria:

1. Patient with severe asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit
2. Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening
3. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
4. Non-smoker patient for at least 1 year and with a prior tobacco consumption < 10 packs/year

Main exclusion criteria:

1. Patient with active lung disease other than asthma (e.g. chronic bronchitis)
2. Female patient who is pregnant or lactating
3. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
4. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Masitinib as add-on to oral corticosteroids; Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids	Drug: Masitinib; 6 mg/kg/day; Other Names: AB1010
PLACEBO_COMPARATOR: Placebo as add-on to oral corticosteroids; Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids	Drug: Placebo; Other Names: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma exacerbation rate	The number of 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
ACQ Score	Asthma Control Questionnaire (ACQ) Score	36 weeks

Collaborators and Investigators

• Sponsor: AB Science
• Investigators: Principal Investigator: Lavinia Davidescu, MD, PhD, University of Medicine and Pharmacy Oradea, Oradea, Romania

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2011
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 7, 2011
• First Posted (ESTIMATE): October 10, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: tyrosine kinase inhibitor; severe persistent asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: AB07015