Journal of Bioequivalence & Bioavailability

Abstract

Pharmacokinetic Bridging Study To Support The Use Of Nemolizumab Prefilled Pen For The Treatment Of Atopic Dermatitis And Prurigo Nodularis

Luca Loprete*, Jabbar Lopez Z, Piketty C, Rasmussen S, Silverberg J, Stander S, Duval V, Machu JL, Ulianov L and Wagner N

Background: Nemolizumab is a monoclonal antibody that targets the receptor alpha of the neuro-immune cytokine IL-31. This clinical PK bridging study was conducted to support the marketing application of the prefilled dual chamber pen. Methods: This was a phase 1, randomized, multicenter, open-label, single-dose, parallel-group study in healthy adult subjects. Participants (N=192) were randomized by device (pen or syringe) and by injection site (abdomen, thigh, arm) and received one subcutaneous 60 mg nemolizumab dose. The primary endpoint pharmacokinetic parameters were analyzed using a linear mixed-effect model. Safety data were summarized descriptively. Results: Mean age was 41.5 years (19 to 65 years), mean body weight was 72.76 kg (45.4 to 107.4 kg) and 61% of participants were female. The geometric least-square mean ratio comparing pen versus syringe was 105.90% for Cmax and 97.69% for AUC0-∞. The associated 90% confidence intervals fall within the 80.00%-125.00% bioequivalence range. No treatment-emergent anti-drug antibodies were detected with the pen. Treatment emergent adverse events were experienced by 56% and 43% of subjects in the syringe and the pen groups, respectively and were primarily mild or moderate in severity. Conclusions: Single dose of nemolizumab administered as new formulation presentation (pen) was bioequivalent to the prefilled dual chamber syringe used in Phase 3 clinical studies. Nemolizumab delivered subcutaneously by pen or syringe was well tolerated, and no new safety risks were identified with the pen. Hence, results from this PK bridging study support the pen presentation as the commercial drug product

Published Date: 2025-12-25; Received Date: 2025-11-25