MedTrace Logo

Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

NCT03560466 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2025-11-21

Study results available
· View outcomes & findings →

Summary

Primary Objective:

* To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
* To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in the Japan sub-study.

Secondary Objectives:

* To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
* To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to:

* Systemic exposure.
* Anti-drug antibodies (ADAs).
* Biomarkers.
* To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study
* To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to:

* Systemic exposure,
* Anti-drug antibodies (ADAs),
* Biomarkers

Conditions

Interventions

DRUG

Dupilumab (SAR231893/REGN668)

Pharmaceutical form: solution for injection Route of administration: subcutaneous (sc)

DRUG

Asthma controller therapies (incl. prednisone/prednisolone)

Pharmaceutical form: powder, or solution, or pill Route of administration: inhaled, oral or parenteral

DRUG

Asthma reliever therapies

Pharmaceutical form: powder or solution Route of administration: inhaled

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2025-04-01
Completion
2025-04-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Hungary
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Poland
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT03560466 on ClinicalTrials.gov