Study of REGN3500 and Dupilumab in Patients With Asthma

NCT03112577 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

  • Asthma, Allergic

Interventions

DRUG

REGN3500

Intravenous (IV) use

DRUG

Dupilumab

Subcutaneous (SC) use

DRUG

Placebo

Matching placebo

DRUG

Fluticasone propionate

Inhalation use

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2019-03-20
Completion
2019-12-09
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03112577 on ClinicalTrials.gov