Overview

Study of REGN3500 and Dupilumab in Patients With Asthma

Status:
Completed

Trial end date:
2019-12-09

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator:

Sanofi

Treatments:

Antibodies, Monoclonal
Fluticasone
Xhance

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