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COMPLETED
NCT04921345
PHASE2

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

Sponsor: Galderma R&D

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

109

Start Date

2021-06-24

Completion Date

2025-04-28

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DRUG

Nemolizumab

Participants will receive subcutaneous (SC) injection of 10, 20 or 30 milligrams (mg) nemolizumab, every 4 weeks (Q4W) for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight.

DRUG

Nemolizumab

Participants will receive SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight.

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

Galderma Investigational Site #8206

Norman, Oklahoma, United States

Galderma Investigational Site #8255

Philadelphia, Pennsylvania, United States

Galderma Investigational Site #9931

Beaumont, Texas, United States

Galderma Investigational Site #78218-3128

San Antonio, Texas, United States

Galderma Investigational Site #6218

Hellerup, Denmark

Galderma Investigational Site #6147

Budapest, Hungary

Galderma Investigational Site #5531

Szeged, Hungary

Galderma Investigational Site #5570

Lodz, Poland

Galderma Investigational Site #6237

Ostrowiec Świętokrzyski, Poland

Galderma Investigational Site #5495

Rzeszów, Poland

Galderma Investigational Site #6262

Warsaw, Poland

Galderma Investigational Site #6261

Wroclaw, Poland

Galderma Investigational Site #5896

Esplugues de Llobregat, Spain