NCT03912259

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

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate-to-severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The maximum study duration was 33 weeks per participants, including a screening period of up to 5 weeks, a 16-week randomized treatment period, and a 12-week follow-up period.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab	Pharmaceutical form: solution, Route of administration: SC
DRUG	Placebo	Pharmaceutical form: solution, Route of administration: SC
DRUG	Emollient (moisturizer)	Pharmaceutical form: cream, Route of administration: topical use

Timeline

• Start date: 2018-12-19
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2019-04-11
• Last updated: 2023-12-19
• Results posted: 2021-04-05

Locations

27 sites across 1 country: China

Regulatory

• FDA-regulated drug study