Study of REGN3500 and Dupilumab in Patients With Asthma

Part of paid clinical trials in Cypress, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03112577
Phase
PHASE1
Status
Completed

Conditions

  • Asthma, Allergic

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • REGN3500 — DRUG
    Intravenous (IV) use
  • Dupilumab — DRUG
    Subcutaneous (SC) use
  • Placebo — DRUG
    Matching placebo
  • Fluticasone propionate — DRUG
    Inhalation use

Study Details

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.

Key Dates

Start date
Jun 15, 2017
Status verified
Jan 2020
Primary completion
Mar 20, 2019
Completion
Dec 9, 2019

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: REGN3500
    REGN3500: masked and randomized dosing regimen per protocol (part 1 only)
  • Experimental: Dupilumab
    Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
  • Experimental: REGN3500 plus dupilumab
    REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
  • Experimental: Placebo
    Placebo: masked and randomized dosing regimen per protocol (part 1 only)
  • Active Comparator: Fluticasone propionate
    Fluticasone propionate: open label dosing regimen per protocol (part 2 only)

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
WCCT GlobalCypressCalifornia90630-

Find similar trials in Cypress, CA

By research site
WCCT Global· Cypress, CA

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