Galderma R&D
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.
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…
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…
A lyophilized powder for solution for SC injection.
Arctuva estimate
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