At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 202 enrolled
Drug / intervention
Dupilumab +1 moredrug
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 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Dupilumab and Matching placebo for Dermatitis, Atopic. Completed, enrolled 202 participants across 48 sites in 4 countries.
Detailed Summary
This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Atopic
CountriesGermany, Poland, United Kingdom, United States
CollaboratorsSanofi
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartNov 2017
Primary CompletionJul 2021
TodayJul 2026
First PostedNov 17, 2017
Enrollment StartNov 30, 2017
Primary CompletionJul 8, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.6 years ago
Interventions
Dupilumabdrug
Solution for injection, subcutaneous (SC)
Matching placebodrug
Solution for injection, subcutaneous (SC)