Conditions: Atopic Dermatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days arm 2: Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days

Interventions: intervention 1: Dupilumab intervention 2: Placebo (for Dupilumab) intervention 3: Topical Corticosteroid (TCS)
Intervention descriptions: intervention 1: Dupilumab 300 mg once weekly (QW) for 4 weeks intervention 2: Placebo (for Dupilumab) once weekly (QW) for 4 weeks intervention 3: TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%

Protocol document: