Dupilumab in Japanese Patients With Atopic Dermatitis

NCT04678882 | Completed Phase 3

• 3 other identifiers: EFC16823U1111-1301-12572020-002601-26
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 19

Brief 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

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI)

  The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition

  At Week 16

Secondary Outcomes (20)

• Percent change in EASI score

  From baseline to week 16

• Percent change in weekly average of daily worst itch numerical rating scale (NRS) for participants aged ≥6 years to <12 years old

  From baseline to week 16

• Proportion of participants with Investigator's Global Assessment (IGA) 0 or 1

  At Week 16

• Percent change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old

  From baseline to week 16

• Percent change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old

  From baseline to week 16

Study Arms (2)

Dupilumab

EXPERIMENTAL

Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks

Drug: Dupilumab SAR231893

Placebo

PLACEBO COMPARATOR

Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

Dupilumab SAR231893 DRUG

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

Dupilumab

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Japanese and ≥6 months to \<18 years of age, at the time of signing the informed consent and/or assent.
• Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit.
• Chronic AD diagnosed at least 1 year prior to the screening visit (for participants between 6 months to \<1 year of age, the requirement is to have had chronic AD for 3 months).
• (Investigator's Global Assessment) IGA ≥ 3 at screening and baseline visits. (Eczema Area and Severity Index) EASI ≥16 at screening and baseline visits. Baseline peak pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 for participants ≥12 to \<18 years of age.
• Baseline worst itch NRS or worst scratch/itch NRS weekly average score for maximum itch or scratch/itch intensity ≥4 for participants ≥6 months to \<12 years of age.
• Body surface area (BSA) of AD involvement \>10% at screening and baseline visits.
• With documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s).
• At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily immediately before the baseline visit.
• Willing and able to comply with all clinic visits and study-related procedures. Participant, either alone or with help of parents/legal guardians (for 6 years old to less than18 years of age) or parents/caregiver or legal guardians (for 6 months to less than 6 years of age) as appropriate, must be able to understand and complete study-related questionnaires.
• Body weight ≥5 kg at baseline. Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if:

• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit or during the screening period.
• Known or suspected immunodeficiency, including history of invasive opportunistic infections Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist.
• Known history of human immunodeficiency virus (HIV)-1 and HIV-2 infection or HIV seropositivity at the screening
• Participants with any of the following result at the screening:
• Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
• Positive hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or,
• Positive hepatitis C antibody (HCV Ab) confirmed by positive hepatitis C virus (HCV) RNA.
• Presence of skin comorbidities that may interfere with study assessments History of malignancy within 5 years before the baseline visit History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy.
• Known or suspected alcohol and/or drug abuse. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection.
• Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
• Participant with any other medical or psychological condition including relevant laboratory or electrocardiogram (ECG) abnormalities at screening Exposure to another systemic or topical investigative drug within a certain time period prior to Visit 1 (screening), Having used any of immunosuppressive/immunomodulating drugs and phototherapy within 4 weeks before the screening visit.
• Past Treatment with biologics as follows:
• Any cell-depleting agents within 6 months before the screening visit.
• Anti-IgE therapy within 4 months before the screening visit.
• Other monoclonal antibodies (which are biological response modifiers): within 5 half-lives (if known) or 16 weeks before the screening visit (Visit 1), whichever is longer.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (19)

Investigational Site Number : 3920011

Nagoya, Aichi-ken, 457-8510, Japan

Location

Investigational Site Number : 3920014

Toyoake-shi, Aichi-ken, 470-1192, Japan

Location

Investigational Site Number : 3920015

Fukutsu-shi, Fukuoka, 811-3217, Japan

Location

Investigational Site Number : 3920001

Hiroshima, Hiroshima, 734-8551, Japan

Location

Investigational Site Number : 3920013

Sapporo, Hokkaido, 004-0063, Japan

Location

Investigational Site Number : 3920009

Sapporo, Hokkaido, 060-0807, Japan

Location

Investigational Site Number : 3920008

Kobe, Hyōgo, 653-0836, Japan

Location

Investigational Site Number : 3920007

Kobe, Hyōgo, 658-0082, Japan

Location

Investigational Site Number : 3920003

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

Investigational Site Number : 3920017

Yokohama, Kanagawa, 221-0825, Japan

Location

Investigational Site Number : 3920010

Yokohama, Kanagawa, 225-0015, Japan

Location

Investigational Site Number : 3920006

Tsu, Mie-ken, 514-0125, Japan

Location

Investigational Site Number : 3920020

Sakai-shi, Osaka, 593-8324, Japan

Location

Investigational Site Number : 3920019

Toyonaka-shi, Osaka, 560-0085, Japan

Location

Investigational Site Number : 3920016

Kumagaya-shi, Saitama, 360-0018, Japan

Location

Investigational Site Number : 3920023

Chuo-ku, Tokyo, 104-0031, Japan

Location

Investigational Site Number : 3920012

Koto-ku, Tokyo, 136-0074, Japan

Location

Investigational Site Number : 3920022

Toshima-ku, Tokyo, 170-0002, Japan

Location

Investigational Site Number : 3920021

Habikino-shi, 583-8588, Japan

Location

Related Links

• 2020-002601-26 EudraCT results
• EFC16823 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: January 15, 2021
• Primary Completion: December 14, 2021
• Study Completion: October 28, 2023
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (19)