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

NCT02573233 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-04-04

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Placebo

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

Dupilumab SAR231893/REGN668

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

fluticasone propionate and salmeterol

Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled

DRUG

budesonide and formoterol

Pharmaceutical form:inhalation aerosol Route of administration: inhaled

DRUG

mometasone furoate and formoterol

Pharmaceutical form:inhalation aerosol Route of administration: inhaled

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-27
Primary Completion
2018-01-03
Completion
2018-01-03
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02573233 on ClinicalTrials.gov