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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2282

Inclusion Criteria

Eligible patients who have completed the entire study duration of DRI12544, or who completed the treatment period in the other previous asthma studies.
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 2011
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

Patients who didn’t complete the DRI12544 study or the treatment period in other previous asthma studies.
Patients who have experienced hypersensitivity reactions to dupilumab which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
Patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratory assessments before enrollment have ruled out an active infection.
Medical history of human immunodeficiency virus (HIV) infection.
Known or suspected medical history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent or prolonged infections, as per investigator judgment.
Evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics or antiprotozoals within 4 weeks before Visit 1; significant viral infections within 4 weeks before Visit 1 that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment).
Patients with any event or laboratory abnormality that, as per Investigator judgment, would adversely affect participation of the patient in this study.
Patients who have traveled to parasitic endemic area within 6 months prior to screening.
For patients from DRI12544 study, drug induced liver injury related criteria at Screening:
- Underlying clinically significant hepatobiliary disease OR
- Alanine Aminotransferase (ALT) >3 Upper Limit of Normal (ULN).
For patients from DRI12544 study, abnormal lab values at Screening:
- Creatine phosphokinase (CPK) >10 ULN OR
- Platelets <100.000 cells/mm^3 OR
- Eosinophils >1500 cells/mm^3

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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