A Multicenter, Open-Label, Single-Group Clinical Study to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab in Pediatric Subjects (Aged 6 to 23 Months) With Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled With Topical Therapy
Galderma R&D
Summary
The primary objective of the study is to assess the pharmacokinetics (PK) and safety of nemolizumab in pediatric participants (aged 6-23 months) with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical treatments.
Description
Participants will be screened up to 4 weeks prior to the Baseline visit. At Baseline/Day 1, all participants will receive a loading dose of nemolizumab high dose administered subcutaneously (SC), followed by nemolizumab low dose SC every 4 weeks (Q4W) during the 52-week treatment period, with the final study treatment administered at Week 48. After completion of the 52-week treatment period, participants will enter an 8-week safety follow-up period through Week 60. Participants who prematurely discontinue the study before the Week 48 visit will be followed for 12 weeks after their last admini…
Eligibility
- Age range
- 0–1 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants greater than and equal to (\>=) 6 to less than (\<) 24 months of age at the screening visit. * Diagnosis of AD according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit. * Eczema Area and Severity Index (EASI) score \>= 16 at both screening and baseline visits. * Investigator's Global Assessment (IGA) score \>= 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both screening and baseline visits. * AD involvement \>= 10 percent (%) of body surface area (BSA) at both screening…
Interventions
- DrugNemolizumab
A lyophilized powder for solution for SC injection.
Location
- Texas Dermatology and Laser Specialist-San AntonioSan Antonio, Texas