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

Phase 1

• Conditions: Asthma; MedDRA version: 20.0 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: EUCTR2017-002134-23-FR
• Lead Sponsor: sanofi-aventis groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-01
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 750

Inclusion Criteria

-Patients with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551.
-Signed written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 560
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

- Patients who experienced any systemic hypersensitivity reactions to the 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
- Clinically significant comorbidity/lung disease other than asthma
- Patients with active autoimmune disease or patients who, as per Investigator's medical judgment, are suspected of having high risk for developing autoimmune disease
- History of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main 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).;Secondary Objective: Not applicable;<br> Primary end point(s): 1. Treatment-emergent adverse events (TEAE) : Percentage of patients reporting any TEAE.<br> 2. TEAE : Event rates per 100 patient-years.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. Up to 3 years.<br> 2. Up to 3 years.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable