Conditions: Dermatitis, Atopic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 708
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15. arm 3: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.

Interventions: intervention 1: Dupilumab intervention 2: Placebo (for Dupilumab)
Intervention descriptions: intervention 1: Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms. intervention 2: Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms.

Protocol document: