ArticleBritish journal of clinical pharmacology2026
Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
- Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis.British journal of clinical pharmacology · 2026Article
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18 authors.
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Abstract
aimsPopulation pharmacokinetic (popPK) and pharmacokinetic-pharmacodynamic (PK/PD) models were developed to support clinical development of nemolizumab, a humanized monoclonal antibody targeting the IL-31 receptor α, in adolescents and adults with moderate-to-severe atopic dermatitis (AD).
methodsStarting from previous analyses, data from phase 2 to phase 3 studies in AD and prurigo nodularis were integrated into popPK model development. In initial PK/PD model development, a turnover model was used for Eczema Area and Severity Index (EASI) and Peak Pruritus Numerical Rating Scale (PP NRS) endpoints, while a continuous-time Markov model was used for Investigator's Global Assessment (IGA) scores. A model-informed drug development (MIDD) approach based on popPK and PK/PD modelling and simulations was applied to support dose selection in patients with AD.
resultsNemolizumab exposures decreased with increasing bodyweight. The popPK simulation predicted different median Ctroughs according to bodyweight <90 kg or ≥90 kg: 2.51 vs. 1.71 μg/mL, respectively. However, PK/PD simulations showed that the proportion of responders for EASI, PP NRS and IGA endpoints was similar in both groups: 37.5%, 55.6% and 31.6% vs. 35.1%, 53.4% and 26.3% for bodyweight <90 kg or ≥90 kg, respectively. Reduced response of IGA to nemolizumab treatment was identified for male subjects (23.4% vs. 34.0%) and severe baseline score (19.3% vs. 32.3%) with consistent trends between bodyweight group.
conclusionsThe overall MIDD approach supported the nemolizumab program by confirming the recommended dosing regimen of 30 mg every four weeks with a 60 mg loading dose in all patients with AD.
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