A study to assess the long-term safety and efficacy of dupilumab administered in patients =6 months to <18 year of age with atopic dermatitis (eczema)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 812

Inclusion Criteria

1. Male or female, =6 months to <18 years of age at the time of screening.
2. Participated in a prior dupilumab study in pediatric patients with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol.

Are the trial subjects under 18? yes
Number of subjects for this age range: 812
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

1. Patients who, during their participation in a prior dupilumab study in pediatric patients with AD, developed a serious adverse event (SAE) deemed related to study drug, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient.
2. Patients, who during their participation in a prior dupilumab study in pediatric patients with AD, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient.
3. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit.
4. History of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit.
5. Known or suspected immunodeficiency.
6. Recent infections requiring anti-infectious treatment
7. Recent history or high risk of clinical endoparasitoses
8. High risk populations (low life expectancy, severe concomitant diseases, etc.)
9. Pregnant or breast-feeding women
10. Women of childbearing potential who are unwilling to practice highly effective contraception
11. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the long-term safety of dupilumab in pediatric patients with AD.;Secondary Objective: The secondary objectives of the study are:<br>- To assess the long-term efficacy of dupilumab in pediatric patients with AD<br>- To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric patients with AD after re-treatment with dupilumab.;Primary end point(s): Incidence and rate of treatment-emergent adverse events (TEAEs) from baseline through the last study visit.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence and rate (events per patient-year) of SAEs and AEs of special interest<br>2. Proportion of patients who achieve and maintain remission (IGA 0-1) over time<br>3. EASI-75: Proportion of patients achieving and maintaining at least 75% reduction in EASI score over time.<br>;Timepoint(s) of evaluation of this end point: Throughout the duration of the study

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