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COMPLETEDPHASE2

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis

NCT04921345•Galderma R&D

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).

Eligibility

Age

2 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
•EASI score \>=16 at both screening and baseline visits
•IGA score \>=3 at both screening and baseline visits
•AD involvement \>=10% of BSA at both screening and baseline visits
•Peak (maximum) PP NRS score of at least 4.0 at both screening and baseline visits
•Agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (TCS) from the screening visit and throughout the study as determined appropriate by the investigator
•Participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol

Exclusion Criteria

•Body weight less than 10 kilogram (kg)
•Child in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
•Participants with a current medical history of chronic bronchitis
•Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit
•Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C (HCV) antibody with positive confirmatory test for HCV (example; polymerase chain reaction \[PCR\]), or human immunodeficiency virus (HIV) antibody at the screening visit
•History of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids
•Known or suspected immunosuppression
•Participants unwilling to refrain from using prohibited medications during the clinical trial.

Locations (23)

Galderma Investigational Site #8636

Fountain Valley, California, United States

Galderma Investigational Site #9937

San Diego, California, United States

Galderma Investigational Site #9930

Vista, California, United States

Galderma Investigational Site #9929

Coral Gables, Florida, United States

Galderma Investigational Site #8142

Indianapolis, Indiana, United States

Galderma Investigational Site #8092

Louisville, Kentucky, United States

Galderma Investigational Site #8155

Troy, Michigan, United States

Galderma Investigational Site #8560

West Bloomfield, Michigan, United States

Galderma Investigational Site #8242

Brooklyn, New York, United States

Galderma Investigational Site #9938

New York, New York, United States

Key Dates

Start Date

June 24, 2021

Primary Completion Date

April 28, 2025

Completion Date

April 28, 2025

Last Updated

July 18, 2025

Enrollment

105

ACTUAL participants

Conditions

Moderate-to-Severe Atopic Dermatitis

Interventions

Nemolizumab

DRUG

Nemolizumab

DRUG

A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis

NCT07321951

Moderate-to-severe Atopic Dermatitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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