Asthma MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Dupilumab
Product Code: SAR231893
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dupilumab
Current Spons
Sponsors
Sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients who have completed a previous dupilumab asthma study (ie, DRI12544) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 549 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: - Patients who did not complete the previous dupilumab asthma study (entire study duration) - Patients who have experienced hypersensitivity reactions to dupilumab - Patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratoryassessments before randomization have ruled out an activeinfection - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in previous dupilumab asthma study ie DRI12544; Secondary Objective: - Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study. - Evaluate dupilumab in patients with asthma who participated in previous dupilumab asthma clinical study, with regards to: * Systemic exposure * Anti-drug antibodies * Biomarkers ;Primary end point(s): Number of participants with adverse events;Timepoint(s) of evaluation of this end point: Week 112 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Vital signs, Clinical laboratory tests, Electrocardiogram, Physical examination - clinically significant changes from baseline 2) Forced expiratory volume in one second - clinically significant changes from baseline 3) Asthma control questionnaire - clinically significant changes from baseline 4) Asthma symptom scores - clinically significant changes from baseline 5) Systemic exposure - changes from baseline 6) Anti-drug antibodies - changes from baseline 7) Biomarkers - changes from baseline ; Timepoint(s) of evaluation of this end point: 1 to 6) Week 112 7) Week 96 | — |
Countries
Argentina, Australia, Belgium, Chile, Denmark, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom
Contacts
Public ContactUnidad Estudios Clínicos
sanofi-aventis, s.a.
Outcome results
None listed