ong-Term Safety Evaluation of Dupilumab in Patients with Asthma (LIBERTY ASTHMA TRAVERSE)

Phase 1

• Conditions: Asthma; MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-003856-19-HU
• Lead Sponsor: Sanofi-aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-06
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2206

Inclusion Criteria

Patients with asthma who completed the treatment period in a previous dupilumab asthma clinical study (ie, PDY14192, EFC13579 or EFC13691) or patients with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

Patients who experienced any hypersensitivity reactions to IMP in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma study;<br> Secondary Objective: Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.<br> Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study, with regards to:<br> - Systemic exposure<br> - Anti-drug antibodies<br> - Biomarkers<br> ;Primary end point(s): The primary endpoint of this study is the number (n) and percentage (%) of patients experiencing any treatment-emergent adverse events (TEAE);Timepoint(s) of evaluation of this end point: At Week 96/Week 108 and/or Week 48/Week 60

Secondary Outcome Measures

Name	Time	Method
<br> Timepoint(s) of evaluation of this end point: 1) and 2) : At Week 96/Week 108 and/or Week 48/Week 60<br> 3) to 8) : At Week 96 and/or Week 48<br> ;<br> Secondary end point(s): 1) Assessment of safety parameters (laboratory data, electrocardiogram and vital signs) - clinically significant changes from baseline<br> 2) Forced expiratory volume in one second - clinically significant changes from baseline<br> 3) Asthma control questionnaire (ACQ-5) - clinically significant changes from baseline<br> 4) Asthma symptom scores - clinically significant changes from baseline<br> 5) Asthma Quality of Life Questionnaire (AQLQS) - clinically significant changes from baseline<br> 6) Serum dupilumab concentrations <br> 7)Anti-drug antibodies - changes from baseline<br> 8) Biomarkers - changes from baseline<br>