Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: SAR440340
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not applicable
Current Sponsor code: SAR440340
Other descriptive name: REGN3500
Concentration unit: mg/ml milli
Sponsors
Sanofi-Aventis Recherche & Developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant must be = 18 years to = 75 of age inclusive (or the minimum legal age for majority in the country of the investigational site). -Adult participants with a physician diagnosis of asthma for at least 12 months prior to screening (Visit 1) based on the Global Initiative for Asthma (GINA) 2019 Guidelines. -Existing treatment with medium to high dose ICS (=500 mcg of fluticasone propionate daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a LABA. Up to two additional controller medications are allowed (LAMA and/or LTRA). Current treatment should be initiated at least 3 months prior to Visit 1 and should be stable = 1 month prior to Visit 1. -Pre-bronchodilator forced expiratory volume (FEV1) =40% and =80% of predicted normal at Visits 1 and 2, prior to randomization. -Asthma Control Questionnaire 5-question version (ACQ-5) score =1.5 at Visits 1 and 2, prior to randomization. -Patients with reversibility of at least 12% and 200 mL in FEV1 after administration of 2 to 4 puffs (200-400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening. -Must have experienced, within 1 year prior to Visit 1, any of the following events: • At least two episodes of treatment with a systemic steroid (oral or parenteral) for worsening asthma; OR • One episode of hospitalization for worsening asthma. -Capable of giving signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 974 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 146
Exclusion criteria
Exclusion criteria: -Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibro-sis, etc) which may impair lung function or another diagnosed pulmonary or systemic disease. -Either clinical or imaging (Chest X-ray, CT, MRI) evidence of lung disease(s) other than asthma within 12 months of Visit 1. -A subject who experiences a severe asthma exacerbation at any time from 4 weeks prior to the Screening (Visit 1) up to and including the Baseline Visit (Visit 2). -History of life threatening asthma in past 1 year prior to screening. -Current smoker or cessation of smoking within 6 months prior to Visit 1. Current vaping or cessation of vaping within 6 months prior to Visit 1 is also not allowed. -A patient with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder. -Patients with a history of a systemic hypersensitivity reaction to a monoclonal antibody. -Anti-IgE therapy within 130 days prior to Visit 1 or any other biologic therapy or systemic immunosuppressant to treat inflammatory disease or autoimmune disease and other diseases, within 2 months or 5 half-lives prior to Visit 1, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of different SAR440340 regimens on forced expiratory volume in 1 second (FEV1) in patients with moderate-to-severe asthma;Secondary Objective: -Evaluate the efficacy of different SAR440340 regimens compared with placebo on the overall rate of severe asthma exacerbations -Evaluate the efficacy of different SAR440340 regimens compared with placebo on FEV1 -Evaluate the efficacy of different SAR440340 regimens compared to placebo on other asthma exacerbation parameters -Evaluate the efficacy of different SAR440340 regimens compared to placebo on other lung function measurements -Evaluate the efficacy of different SAR440340 regimens compared to placebo on asthma control -Evaluate the efficacy of different SAR440340 regimens compared to placebo on asthma symptoms -Evaluate the efficacy of different SAR440340 regimens compared to placebo on quality of life -Evaluate the safety and tolerability of different SAR440340 regimens compared to placebo -Evaluate the pharmacokinetic (PK) profile of different SAR440340 regimens -Evaluate immunogenicity of different SAR440340 regimens;Primary end point(s): Absolute change from baseline in FEV1 (prebronchodilator) ; Absolute change from baseline in FEV1 (prebronchodilator) at week 24 in the intent-to treat (ITT) population with baseline blood eosinophil count =300 cells/mm^3;Timepoint(s) of evaluation of this end point: Baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Annualized rate of severe asthma exacerbations over the 24 to 48-week placebo-controlled (PC) treatment period in the ITT population and in the ITT population with baseline blood eosinophil count =300 cells/mm3; A severe asthma exacerbation event during the study is defined as a deterioration of asthma requiring: Use of systemic corticosteroids for =3 days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids 2-Time to first severe asthma exacerbation during the 24 to 48-week PC treatment period; A severe asthma exacerbation event during the study is defined as a deterioration of asthma requiring: Use of systemic corticosteroids for =3 days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids 3-Absolute change from baseline in FEV1 (prebronchodilator) at week 24 in the ITT population 4- Percent change from baseline in FEV1 (prebronchodilator) at week 24 in the ITT population 5- Annualized rate of loss of asthma control (LOAC) event during the 24 to 48-week PC treatment period LOAC event during the treatment period is a deterioration of asthma defined as any of the following: - A 30% or greater reduction from baseline in morning peak exploratory flow (PEF) on 2 consecutive days - =6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days -Severe asthma exacerbation 6-Time to first loss of asthma control (LOAC) event during the 24 to 48-week PC treatment period 7-Absolute and Percent change from baseline in pre-bronchodilator FEV1 at weeks 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, and 48 8-Absolute and Percent change from baseline in post-bronchodilator FEV1 at weeks 4,12, 24, and 48 9-Change from baseline in forced expiratory flow (FEF) 25-75%, Change from baseline in % predicted FEV1, Change from baseline in forced vital capacity (FVC), Change from baseline in mornin | — |
Countries
Argentina, Canada, Chile, Czech Republic, Italy, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, South Africa, Spain, Ukraine, United States
Contacts
Public ContactUnidad de Estudios Clínicos
sanofi-aventis, s.a.
Outcome results
None listed