Trial results for a Phase 2 study evaluating nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis were posted on ClinicalTrials.gov on 2026-05-26. The study assessed pharmacokinetics, safety, and efficacy, reporting mean serum concentrations ranging from 2110 ng/mL to 5950 ng/mL across different age cohorts.
Background
The study investigated nemolizumab for pediatric participants with moderate-to-severe atopic dermatitis. The trial's purpose was to assess the pharmacokinetics (PK), safety, and efficacy of the drug in this specific patient population.
Trial design
The completed Phase 2 study (NCT04921345) enrolled 109 participants with moderate-to-severe atopic dermatitis. The study's objective was to evaluate the pharmacokinetics, safety, and efficacy of nemolizumab in pediatric participants aged 2-11 years.
Key results
The trial reported nemolizumab serum concentrations across different pediatric cohorts:
- For Cohort 1: Participants Aged 7-11 Year, mean serum concentrations ranged from 4630 ng/mL (SD 1660 ng/mL) to 5950 ng/mL (SD 2240 ng/mL).
- For Cohort 1.1: Participants Aged 7-11 Years, mean serum concentrations ranged from 2110 ng/mL (SD 1000 ng/mL) to 2900 ng/mL (SD 893 ng/mL).
- For Cohort 2: Participants Aged 2-6 Years, mean serum concentrations ranged from 2430 ng/mL (SD 1510 ng/mL) to 3080 ng/mL (SD 1220 ng/mL).
What this means
The posted results provide pharmacokinetic data for nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis. The detailed serum concentration measurements across different age cohorts (2-6 years and 7-11 years) offer insights into how the drug is absorbed, distributed, metabolized, and excreted in these younger populations. This pharmacokinetic profile is crucial for understanding appropriate dosing strategies and will likely inform future clinical development and regulatory submissions for nemolizumab in pediatric atopic dermatitis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04921345, titled "Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis", were posted on 2026-05-26 on clinicaltrials.gov.