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



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:7 - 12
Updated:3/27/2019
Start Date:June 21, 2018
End Date:April 15, 2026
Contact:Trial Transparency email recommended (Toll free number for US & Canada)
Email:Contact-Us@sanofi.com
Phone:800-633-1610

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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

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.

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.
We found this trial at
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Charlotte, North Carolina 28207
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Rolling Hills Estates, California 90274
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