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Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

NCT02528214 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2019-10-01

Study results available
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Summary

Primary Objective:

To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma.

Secondary Objectives:

* To evaluate the safety and tolerability of dupilumab.
* To evaluate the effect of dupilumab in improving participants-reported outcomes.
* To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.

Conditions

Interventions

DRUG

Dupilumab

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

DRUG

Placebo

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

DRUG

Oral corticosteroid therapy (prednisone/prednisolone)

Oral administration.

DRUG

Inhaled corticosteroid (ICS) therapy

Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).

DRUG

Albuterol/Salbutamol

Oral inhalation as needed.

DRUG

Levalbuterol/Levosalbutamol

Oral inhalation as needed.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-15
Primary Completion
2017-09-20
Completion
2017-11-13

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

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 NCT02528214 on ClinicalTrials.gov