CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 165 enrolled
Drug / intervention
Dupilumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03912259
NCT03912259Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Apr 11, 2019·Updated Dec 19, 2023

In Brief

A Phase 3 clinical trial evaluating Dupilumab, Placebo, and 1 other intervention for Atopic Dermatitis. Completed, enrolled 165 participants across 27 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesChina
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 11, 2019
Enrollment StartDec 19, 2018
Primary CompletionFeb 14, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.2 years ago

Interventions

Dupilumabdrug

Pharmaceutical form: solution, Route of administration: SC

Placebodrug

Pharmaceutical form: solution, Route of administration: SC

Emollient (moisturizer)drug

Pharmaceutical form: cream, Route of administration: topical use