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

2018-06-25 04:40:12 | BioPortfolio

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.

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.

Description

Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up.

Study Design

Conditions

Asthma

Intervention

Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies

Location

Investigational Site Number 8400002
Gilbert
Arizona
United States
85234

Status

Recruiting

Source

Sanofi

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-06-25T04:40:12-0400

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