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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
31
Dupilumab 300 mg once weekly (QW) for 4 weeks
Placebo (for Dupilumab) once weekly (QW) for 4 weeks
TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%
Unnamed facility
Berlin, Germany
Unnamed facility
Dresden, Germany
Unnamed facility
Dülmen, Germany
Unnamed facility
Frankfurt, Germany
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (from start of administration of first dose of study drug to the end of study \[up to Day 78\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Time frame: Baseline up to the end of study (up to Day 78)
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Unnamed facility
Gera, Germany
Unnamed facility
Langenau, Germany
Unnamed facility
Münster, Germany
Unnamed facility
Szeged-Hungary, Hungary
Unnamed facility
Szolnok, Hungary
Unnamed facility
Gdansk, Poland
...and 3 more locations