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Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
Sponsor: Galderma R&D
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
Conditions
Interventions
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.
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