At a glance
ClinicalIndex Comparison Record- ✓Age ≥12 to <18 years at screening
- ✓Diagnosis of atopic dermatitis per American Academy of Dermatology consensus criteria
- ✓IGA ≥3 at screening and baseline
- ✓EASI ≥16 at screening and baseline
- ✕Prior participation in a dupilumab clinical study
- ✕Topical corticosteroids or topical calcineurin inhibitors within 2 weeks before baseline
- ✕Immunosuppressive/immunomodulating drugs within 4 weeks before baseline
- ✕Body weight <30 kg at baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Dupilumab and Placebo for Moderate-to-Severe Atopic Dermatitis and 8 related conditions. Completed, enrolled 251 participants across 45 sites in 2 countries.
Detailed Summary
The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe AD.
Study Details
Timeline
Interventions
Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.