At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 422 enrolled
Drug / intervention
Dupilumab +1 moredrug
Likely dose
Dupilumab 300 mgfrom 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 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Multiple Dupilumab Dose Regimens Administered as Monotherapy for Maintaining Treatment Response in Patients With Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Dupilumab and Placebo for Atopic Dermatitis. Completed, enrolled 422 participants.
Detailed Summary
The primary objective of the study was to assess the ability of different Dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with Dupilumab monotherapy compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
Countries--
CollaboratorsSanofi
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartMar 2015
Primary CompletionJul 2016
Study CompletionOct 2016
TodayJul 2026
First PostedMar 20, 2015
Enrollment StartMar 25, 2015
Primary CompletionJul 1, 2016
Study CompletionOct 18, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.3 years ago
Interventions
Dupilumabdrug
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered.
Placebodrug
Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW).