Prurigo nodularis is characterized by intensely itchy nodules that can persist for years and severely impair quality of life. Despite its impact, therapeutic options that address both severe pruritus and disease activity remain inadequate. Vixarelimab, a monoclonal antibody designed to block pathways involved in itch and inflammation, has emerged as a potential disease-modifying treatment.
The phase 2b, double-blind, placebo-controlled trial was conducted across 72 centers in the United States, Canada, Europe, and Asia between December 2020 and August 2023. Adults aged 18 to 80 years with physician-confirmed prurigo nodularis of at least six months’ duration and moderate to severe itch were eligible to participate. A total of 190 participants were randomized, and 189 received at least one dose of the study drug.
During the initial 16-week double-blind period, participants were assigned to one of three monthly subcutaneous doses of vixarelimab—high, mid, or low—or to placebo. This phase was followed by a 36-week open-label extension in which all participants received vixarelimab every two weeks. The primary outcome focused on changes from baseline in the Worst Itch Numeric Rating Scale (WI-NRS), a validated patient-reported measure of itch severity.
The study revealed the following findings:
- Vixarelimab led to rapid, dose-dependent reductions in itch severity compared with placebo, with more than 50% decreases in WI-NRS scores at week 16 in the high- and mid-dose groups, and meaningful improvement was also observed with the low-dose regimen.
- Participants receiving placebo showed only modest reductions in itch scores, highlighting the superior efficacy of vixarelimab across all dose levels.
- A clinically meaningful improvement of at least a 4-point reduction in WI-NRS was achieved by a substantially higher proportion of patients treated with vixarelimab than with placebo.
- Treatment with vixarelimab also resulted in improved overall disease severity, with more patients achieving clear or almost clear skin based on the prurigo nodularis Investigator Global Assessment.
- Clinical benefits were maintained during the open-label extension phase, indicating sustained efficacy with continued therapy.
- No fatal or serious treatment-related adverse events were reported, and vixarelimab was generally well tolerated across dose groups.
- Pharmacokinetic findings demonstrated consistent drug exposure with monthly dosing during the double-blind treatment period.
While the authors noted limitations, including the relatively short placebo-controlled period, the overall results highlight vixarelimab’s potential as an effective long-term therapy for prurigo nodularis. The sustained reduction in itch and improvement in skin lesions point to a favorable benefit–risk profile. Ongoing studies are further evaluating vixarelimab in other inflammatory conditions, which may help clarify its broader therapeutic role.
Reference:
Ständer S, Yosipovitch G, Sofen H, et al. Vixarelimab in Patients With Prurigo Nodularis: A Randomized Clinical Trial. JAMA Dermatol. Published online December 17, 2025. doi:10.1001/jamadermatol.2025.4950
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