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An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

NCT01854047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 776

Last updated 2017-06-26

Study results available
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Summary

Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

* Safety and tolerability
* Dupilumab systemic exposure and anti-drug antibodies

Conditions

Interventions

DRUG

Dupilumab

Solution for injection, Subcutaneous injection

DRUG

placebo

Solution for injection, Subcutaneous injection

DRUG

ICS/LABA therapy

Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

DRUG

Salbutamol/albuterol

Oral inhalation as needed

DRUG

Levosalbutamol/levalbuterol

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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-11-30
Completion
2015-04-30

Countries

  • United States
  • Argentina
  • Australia
  • Chile
  • France
  • Italy
  • Japan
  • Mexico
  • New Zealand
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • 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 NCT01854047 on ClinicalTrials.gov