Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis

Phase 3 Completed 165 enrolled Sanofi Regeneron Pharmaceuticals · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary Objective: To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD). Secondary Objectives: * To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD. * To evaluate the effect of dupilumab on improving patient reported outcomes (PROs). * To evaluate dupilumab immunogenicity.

Timeline

Start: 2018-12-19
Primary completion: 2020-02-14
Completion: 2020-02-14

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo Q2W vs Dupilumab 300 mg Q2W; p <.0001; Difference in Percentage 22.0 (95% CI 11.37 to 32.65) NCT03912259 ↗

Publications

Mickevicius T, Pink AE, Bhogal M, O'Brart D, Robbie SJ. Dupilumab-Induced, Tralokinumab-Induced, and Belantamab Mafodotin-Induced Adverse Ocular Events-Incidence, Etiology, and Management. Cornea. 2023 Apr 1;42(4):507-519. doi: 10.1097/ICO.0000000000003162. Epub 2022 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dupilumab	Monoclonal antibody	300 mg	Subcutaneous
Background	Emollient (moisturizer)	Unknown	—	Topical