Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, =6 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - To assess the long-term efficacy of dupilumab in pediatric patients with AD - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence and rate (events per patient-year) of SAEs and AEs of special interest 2. Proportion of patients who achieve and maintain remission (IGA 0-1) over time 3. EASI-75: Proportion of patients achieving and maintaining at least 75% reduction in EASI score over time. ;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Countries
Canada, Czech Republic, Germany, Hungary, Poland, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed