Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Dupilumab: 175 mg/mL in prefilled syringe to deliver 200 mg in 1.14 mL
Intervention2: Dupilumab: 150 mg/mL in a prefilled syringe to deliver 300 mg in 2 mL
Intervention3: Dupilumab: 200
Sponsors
Sanofi Synthelabo India Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: - Adults and adolescent patients (â�¥12 years of age) with a physician diagnosis of asthma for â�¥12 months, based on the Global Initiative for Asthma (GINA) 2017 Guidelines and the following criteria: A) Existing treatment with medium to high dose ICS (â�¥250 �¼g of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 �¼g/day of fluticasone propionate or equivalent) in combination with a second controller (eg, LABA, LTRA, or theophylline) for at least 3 months with a stable dose â�¥1 month prior to the screening visit (Visit 1). Patients on budesonide/formoterol combo with budesonide 640 �¼g/day can be considered as medium dose ICS and are eligible. - Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose â�¥1 month prior to the screening visit (Visit 1). - Patients requiring maintenance OCS with a stable dose â�¤10 mg/day prednisone or equivalent will be allowed; OCS should be used for at least 3 months with a stable dose â�¥1 month prior to the screening visit (Visit 1). - Pre-bronchodilator forced expiratory volume (FEV1) â�¤80% of predicted normal for adults and â�¤90% of predicted normal for adolescents at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization. - Asthma Control Questionnaire 5-question version (ACQ-5) score â�¥1.5 at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization. - Prior to randomization, reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 �¼g albuterol/salbutamol or levalbuterol/levosalbutamol (2 to 4 inhalations of albuterol/salbutamol or levalbuterol /levosalbutamol, or of a nebulized solution of albuterol/salbutamol or levalbuterol/levosalbutamol, if considered as a standard office practice). - Must have experienced, within 1 year prior to the screening visit (Visit 1), any of the following events: - Treatment with a systemic steroid (oral or parenteral) or treatment with systemic steroid at least twice the previous dose (for patients on OCS maintenance) for worsening asthma at least once. - Hospitalization or emergency medical care visit for worsening asthma, requiring systemic steroids. - Signed written informed consent.
Exclusion criteria
Exclusion criteria: - adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are �18 years of age). - Weight is less than 30 kg at the screening visit (Visit 1) or the randomization visit (Visit 2). - . Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibrosis) which may impair lung function. - A subject who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, treatment with systemic steroids, or treatment with systemic steroid at least twice the previous dose for patients on OCS maintenance) at any time from 1 month prior to the screening visit (Visit 1) up to and including the randomization visit (Visit 2). - Evidence of lung disease(s) other than asthma, either clinical or imaging evidence (eg, chest X-ray, CT, and MRI) within 3 months prior to the screening visit (Visit 1) as per local standard of care. - . A subject who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to the screening visit (Visit 1) or during the screening period. - Current smoker or cessation of smoking within 6 months prior to the screening visit (Visit 1). - Previous smoker with a smoking history >10 pack-years. - Systemic Traditional Chinese Medicine (TCM) or other herbal medications for asthma within 4 weeks prior to the screening visit (Visit 1). - Comorbid disease that might interfere with the evaluation of IMP. - Known or suspected alcohol and/or drug abuse. - . Inability to follow the procedures of the study (eg, due to language problems or psychological disorders). - Patients requiring non-selective beta-1 adrenergic receptor blockers for any reason, or initiation or change in dose of a selective beta-1 adrenergic receptor blocker within 1 month prior to the screening visit (Visit 1) or plan to initiate or change in dose of a selective beta-1 adrenergic receptor blocker during the screening period or the randomized treatment period. - Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days prior to the screening visit (Visit 1) or any other biologic therapy/immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, and multiple sclerosis) as well as other diseases within 2 months or 5 half-lives prior to the screening visit (Visit 1), whichever is longer. - Initiation of allergen immunotherapy within 3 months prior to the screening visit (Visit 1) or dose change from 1 month prior to the screening visit (Visit 1) or a plan to begin allergen immunotherapy or to change its dose during the Screening Period or the Randomized Treatment Period. - Patients on or initiation of Bronchial thermoplasty within 3 years prior to the screening visit (Visit 1) or plan to begin therapy during the Screening Period or the Randomized Treatment Period. - Exposure to another investigative antibody within a time period prior to the screening visit (Visit 1) that is less than 5 half-lives of the antibody. In case the half-life is not known, then the minimum interval since
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in pre-bronchodilator FEV1Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Annualized rate of severe exacerbation events during the 24-week placebo-controlled treatment period - Percent change from baseline in pre-bronchodilator FEV1 at Week 12 - Annualized rate of loss of asthma control (LOAC) event during the 24-week placebo-controlled treatment period - Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 24-week placebo controlled treatment period Timepoint: Week 24 | — |
Countries
China, India
Contacts
Public ContactMs Shraddha Bhatia
Sanofi synthelabo (India) private Limited
Outcome results
None listed