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Clinical trial

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

Read time: 3 mins
Last updated:21st Jun 2018
Identifier: NCT03560466

Brief 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.

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


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 377 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Actual Study Start Date: June 21, 2018
Estimated Primary Completion Date: June 2027
Estimated Study Completion Date: June 2027

Arm:
- Experimental:
Dupilumab

Category Value
Date last updated at source 2019-10-14
Study type(s) Interventional
Expected enrolment 377
Study start date 2018-06-21
Estimated primary completion date 2027-06-01

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