At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
Dupilumab +2 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 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis
In Brief
A Phase 2 clinical trial evaluating Dupilumab, Placebo (for Dupilumab), and 1 other intervention for Atopic Dermatitis. Completed, enrolled 31 participants across 13 sites in 3 countries.
Detailed Summary
The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesGermany, Hungary, Poland
CollaboratorsSanofi
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedJul 12, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.0 years ago
Interventions
Dupilumabdrug
Dupilumab 300 mg once weekly (QW) for 4 weeks
Placebo (for Dupilumab)drug
Placebo (for Dupilumab) once weekly (QW) for 4 weeks
Topical Corticosteroid (TCS)other
TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%