Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients with Moderate to Severe Asthma who Completed the TRAVERSE-LTS12551Clinical Trial
Phase 3
Completed
- Conditions
- Asthmachronic inflammatory disease of the airways10006436
- Registration Number
- NL-OMON45884
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
-Patients with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551.;-Signed written informed consent.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary safety endpoint:<br /><br>Incidence rates, defined as percentage of patients with<br /><br>treatment-emergent adverse events (TEAEs) and event rates per<br /><br>100 patient-years.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>* Incidence rates and event rates per 100 patient-years for<br /><br>adverse events of special interest (AESIs) over the study.<br /><br>* Incidence rates for serious adverse events (SAEs)/death<br /><br>over the study.<br /><br>* Incidence rates for adverse events (AEs) leading to study<br /><br>discontinuation over the study.</p><br>