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, 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, 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. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit 5. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit 6. Diagnosed active endoparasitic infections or at high risk of these infections 7. Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study Note: Other protocol defined Exclusion criteria apply
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. 4. Change from baseline in EASI score at all in-clinic visits post-baseline 5. Percent change from baseline in EASI at all in-clinic visits post-baseline 6. Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline 7. Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) at all in-clinic visits post-baseline 8. Change from baseline in Children’s Dermatology Life Quality Index (CDLQI) for participants =4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed 9. Change from baseline in Infants’ Dermatology Quality of Life Index (IDQOL) for participants <4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed 10. Proportion of responders (defined as participants with IGA 0 or 1) who maintain IGA 0 or 1 during at least 75% of the subsequent* visits during the treatment period 11. For responders (defined as participants with IGA 0 or 1), median percentage of subsequent* visits during the treatment period, at which IGA 0 or 1 is maintained 12. Number of AD flares during the study 13. Annualize event rate of AD flares during the study 14. Proportion of participants with at least one flare during the study 15. Proportion of well-controlled weeks;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Countries
Canada, Czechia, Czech Republic, Germany, Hungary, Poland, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed