Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Primary Objective:
- Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).
Secondary Objectives:
- Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.
Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study, with regards to:
• Systemic exposure
• Anti-drug antibodies
• Biomarkers
Study Type: Interventional
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Estimated Enrollment: 2206
Study Start Date: July 21, 2014
Estimated Study Completion Date: October 2, 2019
Estimated Primary Completion Date: October 2, 2019 (Final data collection date for primary outcome measure)
Arms:
- Experimental: dupilumab treatment
| Category | Value |
|---|---|
| Date last updated at source | 2017-10-18 |
| Study type(s) | Interventional |
| Expected enrolment | 2206 |
| Study start date | 2014-07-21 |
| Estimated primary completion date | 2019-10-02 |