Asthma MedDRA version: 20.0 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 in pre-filled syringe
INN or Proposed INN: dupilumab
Current Sponsor code: SAR231893
Other descriptive name:
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153). -Signed written informed consent/assent. - Patients who are not able to complete their treatment in Study EFC14153 due to the COVID-19 pandemic will be allowed to enroll into Study LTS14424. Patients who enroll in LTS14424 after completing the EFC14153 EOS visit should have eligibility for LTS14424 reevaluated including background medication check and laboratory assessments (including CBC with differential and basic chemistry) within 1 month prior to LTS14424 Visit 1. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function. -Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders). -Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study. -Patients or his/her parent(s)/caregiver(s)/legal guardian(s) is related to the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff thereof directly involved in the conduct of the study. -Patients who experienced any hypersensitivity reactions to dupilumab in a previous dupilumab study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient. -Any abnormalities or adverse events at screening (last treatment visit in the study EFC14153 will be the screening visit) that per Investigator judgment would adversely affect patient’s participation in this study or would require permanent IMP discontinuation. -For female patients who have commenced menstruating at any time during the study and are either: -Found to have a positive urine pregnancy test, or -Sexually active, not using an established acceptable contraceptive method. -Planned live, attenuated vaccinations during the study. -Patients with active autoimmune disease or patients using immunosuppressive therapy for autoimmune disease (eg, juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus) at enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.;Secondary Objective: -To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. -To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: -Systemic exposure. -Anti-drug antibodies (ADAs). -Biomarkers.;Primary end point(s): Treatment-emergent-adverse-event (TEAEs): The number (n) and percentage (%) of patients experiencing any TEAEs.;Timepoint(s) of evaluation of this end point: From Day 1 up to Week 64 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Severe asthma exacerbation events: Annualized rate of severe asthma exacerbation events, during the treatment period 2) Change in % predicted FEV1: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline 3) Change in absolute FEV1: Change in absolute FEV1 - Clinically significant changes from baseline 4) Change in FVC: Change in forced vital capacity (FVC) 5) Change in FEF: Change in forced expiratory flow [FEF] 25-75%) 6) Assessment of dupilumab concentration: Serum dupilumab concentrations - Changes from first dupilumab injection 7) Assessment of immunogenicity: Titers of Anti-dupilumab antibodies 8) Assessment of blood Eosinophil count: Blood: Eosinophil count 9) Assessment of immunoglobulins: Serum: Immunoglobulins (Ig) ;Timepoint(s) of evaluation of this end point: 1) From Day 1 up to Week 52 2) to 9) From Day 1 up to Week 64 | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Hungary, Italy, Lithuania, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Turkey, Ukraine, United States
Outcome results
None listed