At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 671 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 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Dupilumab and Placebo (for Dupilumab) for Dermatitis, Atopic. Completed, enrolled 671 participants across 101 sites in 10 countries.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Atopic
CountriesBulgaria, Canada, Denmark, Estonia, Finland, Germany, Japan, Singapore, Spain, United States
CollaboratorsSanofi
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedOct 2014
Primary CompletionNov 2015
Study CompletionFeb 2016
TodayJul 2026
First PostedOct 29, 2014
Enrollment StartOct 1, 2014
Primary CompletionNov 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.7 years ago
Interventions
Dupilumabdrug
Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms
Placebo (for Dupilumab)drug
Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms