At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 708 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 708 participants across 93 sites in 11 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
CountriesCanada, France, Germany, Hong Kong, Italy, Lithuania, Poland, South Korea, Sweden, United Kingdom, United States
CollaboratorsSanofi
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartNov 2014
Primary CompletionOct 2015
Study CompletionJan 2016
TodayJul 2026
First PostedOct 29, 2014
Enrollment StartNov 30, 2014
Primary CompletionOct 31, 2015
Study CompletionJan 31, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 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.