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Clinical trial

Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)

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Last updated:29th Aug 2018
Identifier: NCT03620747

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

- Experimental:

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

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