Asthma, Allergic
Conditions
Brief summary
To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.
Interventions
DRUGDupilumab
Subcutaneous (SC) use
DRUGREGN3500
Intravenous (IV) use
DRUGPlacebo
Matching placebo
DRUGFluticasone propionate
Inhalation use
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
KEY Inclusion Criteria: 1. Male or female aged between 18 and 60 years 2. Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening 3. Has a history of mild allergic asthma for at least 6 months 4. Is a non-smoker or ex-smoker for at least 12 months KEY
Exclusion criteria
1. Has a history of life-threatening asthma 2. Has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening 3. Has a history of severe allergies or history of an anaphylactic reaction 4. Has a history of drug or alcohol abuse within a year prior to the screening visit Note: other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo | Screening (pre-treatment) to week 4 after treatment initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of TEAEs | Baseline to week 42 | — |
| Serum concentration-time profile of REGN3500 | Baseline to week 42 | Assessed by maximum plasma concentration \[Cmax\] |
| Serum concentration-time profile of REGN3500: Tmax (time at Cmax) | Baseline to week 42 | — |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Baseline to week 42 | — |
| Immunogenicity of REGN3500 and dupilumab | Baseline to week 42 | Assessed by measurement of anti-drug antibodies (ADAs) |
| Serum concentration of total IL-33 after single IV dose | Up to Week 42 | — |
| Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone | Screening (pre-treatment) to day 4 after treatment initiation | — |
| Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration) | Baseline to week 42 | — |
Countries
United Kingdom, United States
Outcome results
None listed