Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

Clinical Trial ID: NCT03560466

Description

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. 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.

Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up.


Criteria

Inclusion criteria: - 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 Visit 28, considered as Visit 1 for LTS14424). 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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  • Start Date

    2018-06-21

  • Last Updated

    2019-05-03

  • Sponsor

    Regeneron Pharmaceuticals

  • Condition Name

    Asthma

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