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A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis (CHRONOS)
The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.
Details
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 740 |
| Start date | 2014-09 |
| Completion | 2016-10 |
Conditions
- Atopic Dermatitis
Interventions
- Dupilumab
- Placebo (for Dupilumab)
- Topical Corticosteroid (TCS)
Primary outcomes
- Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 — Baseline to Week 16
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported.
Countries
United States, Australia, Canada, Czechia, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Romania, South Korea, Spain, United Kingdom