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Dupilumab in Japanese Patients With Atopic Dermatitis

NCT04678882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-09-12

No results posted yet for this study

Summary

Primary Objective:

To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS)

Secondary Objective:

To evaluate the efficacy of dupilumab administered concomitantly with TCS. To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants.

To assess immunogenicity as determined by the incidence, titer, and clinical impact of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients with atopic dermatitis (AD) (aged ≥6 months to \<18 years old) To assess the concentration of dupilumab in serum following administration concomitantly with TCS.

Conditions

Interventions

DRUG

Placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

DRUG

Dupilumab SAR231893

Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-12-14
Completion
2023-10-28

Countries

  • Japan

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 NCT04678882 on ClinicalTrials.gov