Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Asthma
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion criteria:
Medical diagnosis of persistent asthma for at least 12 months whose:
- airway inflammation likely to be eosinophilic,
- asthma partially controlled or uncontrolled on ICS plus LABA therapy.
- On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol, Mometasone/Formoterol combination therapy for at least 1 month prior to screening.
- Signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.
Exclusion criteria:
- Less than 18 years or greater than 65 years of age.
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation.
- Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests.
- Beta-adrenergic receptor blockers required for any reason.
- Current smoker or cessation of smoking within the 6 months prior to screening.
- Previous smoking with a smoking history >10 cigarette pack/years.
- Participation in another study within 6 months prior to screening if the study medication was an antibody or within 30 days prior to screening for all other study medications.
- Known or suspected non-compliance, alcohol or drug abuse.
- Inability to follow the procedures of the study (e.g, due to language problems, psychological disorders).
- Concomitant severe diseases or diseases for which the use of ICS or LABA were contraindicated.
- Known allergy to doxycycline or related compounds.
- Pregnancy or intention to become pregnant during the course of the study, breast feeding, or unwillingness to use a highly effective method of contraception throughout the study in women of childbearing potential.
- Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 840047
- Investigational Site Number 840046
- Investigational Site Number 840032
- Investigational Site Number 840036
- Investigational Site Number 840005
- Investigational Site Number 840007
- Investigational Site Number 840048
- Investigational Site Number 840035
- Investigational Site Number 840041
- Investigational Site Number 840042
- Investigational Site Number 840039
- Investigational Site Number 840024
- Investigational Site Number 840002
- Investigational Site Number 840031
- Investigational Site Number 840011
- Investigational Site Number 840017
- Investigational Site Number 840026
- Investigational Site Number 840044
- Investigational Site Number 840029
- Investigational Site Number 840028
- Investigational Site Number 840038
- Investigational Site Number 840021
- Investigational Site Number 840053
- Investigational Site Number 840014
- Investigational Site Number 840015
- Investigational Site Number 840003
- Investigational Site Number 840010
- Investigational Site Number 840006
- Investigational Site Number 840013
- Investigational Site Number 840022
- Investigational Site Number 840025
- Investigational Site Number 840008
- Investigational Site Number 840018
- Investigational Site Number 840004
- Investigational Site Number 840023
- Investigational Site Number 840045
- Investigational Site Number 840001
- Investigational Site Number 840012
- Investigational Site Number 840016
- Investigational Site Number 840040
- Investigational Site Number 840037
- Investigational Site Number 840009
- Investigational Site Number 840027
- Investigational Site Number 840030
- Investigational Site Number 840050
- Investigational Site Number 840052
- Investigational Site Number 840049
- Investigational Site Number 840020
- Investigational Site Number 840019
- Investigational Site Number 840034
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo (for Dupilumab)
Dupilumab 300 mg qw
Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.