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
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 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 and baseline visits. (Note: BSA to be derived from the SCORing Atopic Dermatitis (SCORAD).)
• Weekly average of worst scratch/itch Numeric Rating Scale (WSI-NRS) score of at least 4 at both screening and baseline visits as assessed by the parent(s)/caregiver:
‣ Screening WSI-NRS score will be determined by a single WSI-NRS assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit.
⁃ Baseline WSI-NRS score will be determined based on the average of daily WSI-NRS scores (score ranging from 0 to 10) during the 7 days immediately preceding baseline (rounding not permitted). A minimum of 4 daily scores out of the 7 days immediately preceding baseline is required for this calculation. For participants who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned enrollment date, enrollment should be postponed until this requirement is met, without exceeding the maximum screening duration of 4 weeks.
• Documented history by a physician and/or investigator of inadequate response to existing topical AD medications or use of systemic therapies for control of the disease (within 6 months before the screening visit).
• Participant's parent(s)/caregiver willing and able to comply with all time commitments and procedural requirements of the clinical study protocol.
• Participant's parent(s)/caregiver understand and sign a parental Informed Consent Form (ICF) before any study-related procedures are performed.
• Participant's parent(s)/caregiver agree to apply a moisturizer daily from the screening visit and liberally as needed throughout the study; if applying a prescribed topical corticosteroid (TCS) prior to study enrollment, agree to continue at the same stable dose from screening and throughout the study as determined appropriate by the investigator.