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

Sanofi

Status and phase

Active, not recruiting

Phase 3

Conditions

Asthma

Treatments

Drug: Asthma reliever therapies

Drug: Asthma controller therapies (incl. prednisone/prednisolone)

Drug: Dupilumab (SAR231893/REGN668)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03560466

LTS14424

2017-003317-25 (EudraCT Number)

U1111-1200-1757 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

365 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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) 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).

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.

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.