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Study of REGN3500 and Dupilumab in Patients With Asthma

CompletedPhase 1

Sponsor: Regeneron Pharmaceuticals

Conditions: Asthma, Allergic

Interventions: REGN3500, Dupilumab, Placebo, Fluticasone propionate

Countries: United States, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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/exclusion criteria apply

Locations (5)

Cypress, California, United States
Belfast, United Kingdom
London, United Kingdom
London, United Kingdom
Manchester, United Kingdom