Resumen

Primary 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. * To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in the Japan sub-study. Secondary Objectives: * 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. * To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study * To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: * Systemic exposure, * Anti-drug antibodies (ADAs), * Biomarkers

Descripción detallada

Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up. Japan substudy: Study duration per participant is approximately 68 weeks including 3-5 weeks screening period, 52 weeks treatment period and 12 weeks post treatment follow-up period.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 11 YearsSexo: ALL

Criterios de inclusión

Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153).
Signed written informed consent/assent. Specific for Brazil: EFC14153 patients from Brazil, who prematurely discontinued Investigational Medicinal Product (IMP) to receive Yellow Fever vaccine (a live attenuated vaccine) during Yellow Fever outbreak, are allowed to be enrolled in LTS14424 after completing the required procedures in EFC14153 (completion of remaining visits and procedures until end of treatment (EOT) V28, considered as V1 for LTS14424).
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 complete blood count \[CBC\] with differential and basic chemistry) within 1 month prior to LTS14424 Visit 1.
For Japan sub-study
Signed written inform consent/assent
Children 6 to \<12 years of age, with a physician diagnosis of persistent asthma for ≥12 months prior to screening
Blood eosinophil count ≥150 cells/μL or fractional exhaled nitric oxide (FeNO) ≥20 parts per billion (ppb) at screening visit (Visit 0).

Criterios de exclusión

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.
For Japan sub-study:
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 at the screening and enrollment visits.
Patients who previously have been treated with dupilumab
Diagnosed with active parasitic infection (helminthes); suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization
Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per Investigator's judgment.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Intervenciones

drug

Dupilumab (SAR231893/REGN668)

Pharmaceutical form: solution for injection Route of administration: subcutaneous (sc)

drug

Asthma controller therapies (incl. prednisone/prednisolone)

Pharmaceutical form: powder, or solution, or pill Route of administration: inhaled, oral or parenteral

drug

Asthma reliever therapies

Pharmaceutical form: powder or solution Route of administration: inhaled

Ubicaciones

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320001

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320004

Vicente Lopez, Buenos Aires F.D., Argentina

Investigational Site Number : 0320003

Buenos Aires, Argentina

Investigational Site Number : 0320006

Mendoza, Argentina

One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dupilumab (SAR231893/REGN668)

Asthma controller therapies (incl. prednisone/prednisolone)

Asthma reliever therapies

Ubicaciones

Investigational Site Number : 0320002

Investigational Site Number : 0320001

Investigational Site Number : 0320004

Investigational Site Number : 0320003

Investigational Site Number : 0320006

Patrocinadores