Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Dupilumab
Product Code: SAR231893
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Dupilumab
Current Sponsor code: SAR231893
Concentration unit: mg
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Adults and adolescent patients (=12 years of age) with a physician diagnosis of asthma for =12 months, based on the Global Initiative for Asthma 2017 Guidelines and the following criteria: -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 =1 month prior to the screening visit (Visit 1). -Patients requiring maintenance oral corticosteroids (OCS) with a stable dose =10 mg/day prednisone or equivalent will be allowed; OCS should be used for at least 3 months with a stable dose =1 month prior to the screening visit (Visit 1). -Pre-bronchodilator FEV1 = 80% of predicted normal for adults and =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 =1.5 at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization. - For patients not requiring maintenance OCS, screening blood eosinophil count =150 cells/µL or FENO =25 parts per billion (ppb); for patients requiring maintenance OCS, there is no minimum requirement for blood eosinophil count and FENO level Are the trial subjects under 18? yes Number of subjects for this age range: 61 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1033 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 121
Exclusion criteria
Exclusion criteria: -Patients 10 pack-years. - Comorbid disease that might interfere with the evaluation of investigational medicinal product (IMP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma;Secondary Objective: -To evaluate the safety and tolerability of dupilumab -To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life -To evaluate dupilumab systemic exposure and immunogenicity ;Primary end point(s): Change in pre-bronchodilator forced expiratory volume (FEV1) - Absolute change from baseline in pre-bronchodilator FEV1 at Week 12;Timepoint(s) of evaluation of this end point: Baseline to week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1.,3. - 6. during the 24-week placebo-controlled treatment period 2. Baseline to week 12 7. - 13. Baseline to week 24 14. Baseline to week 36 ;Secondary end point(s): -Annualized rate of severe exacerbation events -Percent change from baseline in pre-bronchodilator FEV1 -Annualized rate of loss of asthma control (LOAC) event -Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit -Time to first severe exacerbation event -Time to first LOAC -Change from baseline in Asthma Control Questionnaire (ACQ)-5 score -Change from baseline in ACQ-7 score -Morning/evening asthma symptom score (e-diary) -Nocturnal awakenings (e-diary) -Use of daily puffs of rescue medication -Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (=12 years) (AQLQ+12) -Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) -Assessment of adverse events (AEs) | — |
Countries
China, India
Contacts
Public Contact-
sanofi-aventis recherche et développement
Outcome results
None listed