Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
Brief Summary:
Primary Objective:
To describe the long-term safety of dupilumab in treatment of patients with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).
Detailed Description:
Duration per participant is until dupilumab approval for use in asthma and market availability to the patient, or a maximum of 144 weeks (ie, about 3 years) after the Start of Treatment (V1), whichever comes first.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial
Actual Study Start Date: August 30, 2018
Estimated Primary Completion Date: September 2021
Estimated Study Completion Date: September 2021
Arm:
- Experimental: Dupilumab
Category | Value |
---|---|
Date last updated at source | 2019-07-08 |
Study type(s) | Interventional |
Expected enrolment | 750 |
Study start date | 2018-08-30 |
Estimated primary completion date | 2021-09-01 |