At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 78 enrolled
Drug / intervention
Dupilumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years With Atopic Dermatitis
In Brief
A Phase 2 clinical trial evaluating Dupilumab for Atopic Dermatitis. Completed, enrolled 78 participants across 26 sites in 6 countries.
Detailed Summary
The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age). The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesCanada, Czechia, Germany, Hungary, Poland, United Kingdom
CollaboratorsSanofi
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedApr 2015
Primary CompletionMar 2016
TodayJul 2026
First PostedApr 3, 2015
Enrollment StartMar 31, 2015
Primary CompletionMar 31, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.2 years ago
Interventions
Dupilumabdrug