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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
WCCT Global
Cypress, California, United States
Celerion
Belfast, United Kingdom
Hammersmith Medicine Research
London, United Kingdom
Respiratory Clinical Trials Ltd
London, United Kingdom
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
Time frame: Screening (pre-treatment) to week 4 after treatment initiation
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to week 42
Severity of TEAEs
Time frame: Baseline to week 42
Serum concentration-time profile of REGN3500
Assessed by maximum plasma concentration \[Cmax\]
Time frame: Baseline to week 42
Serum concentration-time profile of REGN3500: Tmax (time at Cmax)
Time frame: Baseline to week 42
Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)
Time frame: Baseline to week 42
Immunogenicity of REGN3500 and dupilumab
Assessed by measurement of anti-drug antibodies (ADAs)
Time frame: Baseline to week 42
Serum concentration of total IL-33 after single IV dose
Time frame: Up to Week 42
Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone
Time frame: Screening (pre-treatment) to day 4 after treatment initiation
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Inhalation use
The Medicines Evaluation Unit
Manchester, United Kingdom