Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Sanofi
Study ID
NCT02573233
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Pharmaceutical form:solution Route of administration: subcutaneous
  • Dupilumab SAR231893/REGN668 — DRUG
    Pharmaceutical form:solution Route of administration: subcutaneous
  • fluticasone propionate and salmeterol — DRUG
    Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled
  • budesonide and formoterol — DRUG
    Pharmaceutical form:inhalation aerosol Route of administration: inhaled
  • mometasone furoate and formoterol — DRUG
    Pharmaceutical form:inhalation aerosol Route of administration: inhaled

Study Details

Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

Key Dates

Start date
Jan 27, 2016
Status verified
Mar 2022
Primary completion
Jan 3, 2018
Completion
Jan 3, 2018

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14, added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
  • Experimental: Dupilumab
    Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14, added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.

Primary Outcome Measure

Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840402TucsonArizona85724-
Investigational Site Number 840403DenverColorado80206-
Investigational Site Number 840401BostonMassachusetts02115-
Investigational Site Number 840002St LouisMissouri63110-
Investigational Site Number 840404Winston-SalemNorth Carolina27157-1071-
Investigational Site Number 840028PittsburghPennsylvania15213-

Find similar trials in Tucson, AZ

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Investigational· Tucson, AZInvestigational· Denver, COInvestigational· Boston, MAInvestigational· St Louis, MOInvestigational· Winston-Salem, NCInvestigational· Pittsburgh, PA

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