Asthma
Conditions
Interventions
investigational material(s)
Generic name etc : SAR231893
INN of investigational material : Dupilumab
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administration
Sponsors
Sanofi K.K.
Regeneron Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551. - Signed written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Primary Endpoints -Treatment-emergent adverse events (TEAE). Percentage of patients reporting any TEAE. Up to 3 years -TEAE. Event rates per 100 patient-years. Up to 3 years | — |
Countries
Africa, Europe, Japan, Middle East, North America, South America
Outcome results
None listed