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drugset / Trial / NCT03389893

Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis

NCT03389893 ↗

Phase 4 Terminated 72 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Atopic Dermatitis Research Network · collabRegeneron Pharmaceuticals · collabRho Federal Systems Division, Inc. · collabSanofi · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to understand the effect that T helper 2 (Th2) blockade has on well-described pathophysiological features of Atopic Dermatitis (AD), for example: barrier, epidermal activation, dysbiosis and epidermal lipids.

Timeline

Start
2018-07-25
Primary completion
2020-04-03
Completion
2020-09-09

Outcome

Met primary endpoint

Stopped (Enrollment): “Due to inability to meet accrual goals within the funding period.”

registry Dupilumab+Open Label Extension and Follow-Up vs Placebo+Open Label Extension and Follow-Up; p <0.001; Geometric Mean Ratio 0.033 (95% CI 0.008 to 0.131) NCT03389893 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody 300 mg Subcutaneous

Indications

atopic eczema