Resumen

Primary Objective: To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. * To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

Descripción detallada

The total duration of study period for each participant is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up period of 12 weeks.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:
a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1.
i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent).
ii) Participants 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 Visit 1.

Criterios de exclusión

Participants \<12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are ≥18 years of age).
Weight is less than 30 kilograms.
Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography \[CT\], magnetic resonance imaging \[MRI\]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis.
Current smoker or cessation of smoking within 6 months prior to Visit 1.
Previous smoker with a smoking history \>10 pack-years.
Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Intervenciones

drug

Dupilumab

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

drug

Placebo

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

drug

Inhaled corticosteroid (ICS) therapy

Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)

drug

Albuterol/Salbutamol

Oral inhalation as needed

drug

Levalbuterol/Levosalbutamol

Oral inhalation as needed

Ubicaciones

Investigational Site Number 032006

Bahía Blanca, Argentina

Investigational Site Number 032002

Buenos Aires, Argentina

Investigational Site Number 032011

Caba, Argentina

Investigational Site Number 032007

Caba, Argentina

Investigational Site Number 032001

Caba, Argentina

Investigational Site Number 032003

Caba, Argentina

Investigational Site Number 032010

Caba, Argentina

Investigational Site Number 032005

Capital Federal, Argentina

Investigational Site Number 032008

La Plata, Argentina

Investigational Site Number 032004

Rosario, Argentina

Investigational Site Number 032012

San Miguel de Tucumán, Argentina

Investigational Site Number 032009

San Miguel de Tucumán, Argentina

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dupilumab

Placebo

Inhaled corticosteroid (ICS) therapy

Albuterol/Salbutamol

Levalbuterol/Levosalbutamol

Ubicaciones

Investigational Site Number 032006

Investigational Site Number 032002

Investigational Site Number 032011

Investigational Site Number 032007

Investigational Site Number 032001

Investigational Site Number 032003

Investigational Site Number 032010

Investigational Site Number 032005

Investigational Site Number 032008

Investigational Site Number 032004

Investigational Site Number 032012

Investigational Site Number 032009

Patrocinadores