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

Phase 1

• Conditions: Asthma; MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-003317-25-HU
• Lead Sponsor: Sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-13
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 354

Inclusion Criteria

-Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153).
-Signed written informed consent/assent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 236
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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified