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