Asthma
Conditions
Brief summary
Primary Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma Secondary Objectives: * 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
Detailed description
The total duration of study per patient is approximately 40 weeks, including 3 to 5 weeks of screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.
Interventions
Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUGPlacebo
Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUGAsthma Controller Therapies (include prednisone/prednisolone)
Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhalation, oral
Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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 Fractional Exhaled Nitric Oxide (FENO) ≥25 parts per billion (ppb); for patients requiring maintenance OCS, there is no minimum requirement for blood eosinophil count and FENO level.
Exclusion criteria
* Patients \<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, patient 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 or other lung diseases (eg, idiopathic pulmonary fibrosis) which may impair lung function. * A patient who experiences a severe asthma exacerbation (defined as 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, computed tomography, and magnetic resonance imaging) within 3 months prior to the screening visit (Visit 1) as per local standard of care. * 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. * Comorbid disease that might interfere with the evaluation of investigational medicinal product (IMP). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pre-bronchodilator forced expiratory volume (FEV1) | Baseline to Week 12 | Absolute change from baseline in pre-bronchodilator FEV1 at Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of daily puffs of rescue medication | Baseline to Week 24 | Change from baseline at Week 24 in use of daily puffs of rescue medication |
| Annualized rate of severe exacerbation events | During the 24-week placebo-controlled treatment period | Annualized rate of severe exacerbation events during the 24-week placebo-controlled treatment period |
| Percent change from baseline in pre-bronchodilator FEV1 | Baseline to Week 12 | 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 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 | Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 24-week placebo-controlled treatment period |
| Time to first severe exacerbation event | During the 24-week placebo-controlled treatment period | Time to first severe exacerbation event during the 24-week placebo-controlled treatment period |
| Nocturnal awakenings (e-diary) | Baseline to week 24 | Change from baseline at Week 24 in nocturnal awakenings (e-diary) |
| Change from baseline in Asthma Control Questionnaire (ACQ)-5 score | Baseline to Week 24 | Change from baseline in ACQ-5 score at Week 24 |
| Change from baseline in ACQ-7 score | Baseline to Week 24 | Change from baseline in ACQ-7 score at Week 24 |
| Morning/evening asthma symptom score (e-diary) | Baseline to Week 24 | Change from baseline at Week 24 in morning/evening asthma symptom score (e-diary) |
| Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (≥12 years) (AQLQ+12) | Baseline to Week 24 | Change from baseline in AQLQ with Standardized Activities (≥12 years) (AQLQ+12) at Week 24 |
| Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) | Baseline to Week 24 | Change from baseline in EQ-5D-5L at Week 24 |
| Assessment of adverse events (AEs) | Baseline to week 36 | Number of participants with adverse events (AEs) |
| Time to first LOAC | During the 24-week placebo-controlled treatment period | Time to first LOAC during the 24-week placebo-controlled treatment period |
Countries
China, India
Outcome results
None listed