MedTrace Logo

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

NCT03912259 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2023-12-19

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2020-02-14
Completion
2020-02-14
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03912259 on ClinicalTrials.gov