Asthma MedDRA version: 19.1 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
Other descriptive name:
Sponsors
SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult and adolescent patients with a physician diagnosis of asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2014 guidelines and the following criteria: - Patients with severe asthma and a well-documented, regular prescribed treatment of maintenance corticosteroids in the 6 months prior to Visit 1 and using a stable OCS dose (ie, no change of OCS dose) for 4 weeks prior to Visit 1. Patients must be taking 5 to 35 mg/day of prednisone/prednisolone, or the equivalent, at Visit 1 and at the Randomization visit. In addition, the patient must agree to switch to study-required prednisone/prednisolone as their OCS and use it per protocol for the duration of the study. - Existing treatment with high-dose inhaled corticosteroid (ICS; >500 mcg total daily dose of fluticasone propionate or equivalent) in combination with a second controller (ie, long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA]) for at least 3 months with a stable dose of ICS for =1 month prior to Visit 1. In addition, patients requiring a third controller for their asthma are considered eligible for this study, and it should also be used for at least 3 months with a stable dose = 1 month prior to Visit 1. - A forced expiratory volume in 1 second (FEV1) =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: • Patients 10 pack-years. • Comorbid disease that might interfere with the evaluation of the investigational medicinal product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.;Secondary Objective: To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in improving patient-reported outcomes. To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies. ;Primary end point(s): Percentage reduction in OCS dose while maintaining asthma control ;Timepoint(s) of evaluation of this end point: Baseline, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Proportion of patients achieving a reduction of 50% or greater in their OCS dose compared with baseline while maintaining asthma control 2 - Absolute reduction of OCS dose compared with the baseline dose while maintaining asthma control. 3 - Proportion of patients achieving a reduction of OCS dose to <5 mg/day while maintaining asthma control. 4 - Proportion of patients no longer requiring OCS while maintaining asthma control. 5 - Proportion of patients achieving their maximum possible OCS dose reduction while maintaining asthma control.;Timepoint(s) of evaluation of this end point: 1,2,5 : Baseline, Week 24 3,4 : week 24 | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, Colombia, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Ukraine, United States
Contacts
Public Contactteam manager
sanofi-aventis the Netherlands bv
Outcome results
None listed