RE-UNITE-PN Launched to Evaluate Nemolizumab in Prurigo Nodularis
Key Takeaways
RE-UNITE-PN is a prospective, Phase 4 study evaluating nemolizumab in real-world clinical settings for prurigo nodularis.
The study aims to complement Phase 3 trial data by capturing patient- and physician-reported outcomes over 12 months.
Approximately 600 patients will be observed for effectiveness and safety across diverse patient subgroups.
A new international, non-interventional study aims to provide critical real-world data on nemolizumab’s performance in patients with moderate-to-severe prurigo nodularis (PN). The RE-UNITE-PN study (NCT06988618), sponsored by Galderma, is designed to complement pivotal Phase 3 data by enrolling approximately 600 adults across 150 clinical sites in Europe and North America.
The prospective, multicenter study includes patients newly initiated on nemolizumab based on physician discretion and consistent with local labels, with no additional procedures beyond standard care. The primary endpoint is the proportion of patients achieving an IGA-CPG score of 0 or 1 (clear or almost clear) and the change in PP-NRS score at six months. Secondary and exploratory endpoints include extended efficacy and quality-of-life measures up to 12 months, including SD-NRS, DLQI, and TSQM-9 assessments.
By following patients over a year, the study will analyze outcomes using both physician-reported and patient-reported measures across multiple subgroups, including age, Fitzpatrick skin type, and disease severity. Importantly, safety outcomes such as serious adverse events and non-serious adverse drug reactions will be monitored throughout.
“This non-interventional study, with large sample size and real-world design, is expected to address data gaps from pivotal clinical trials and complement existing evidence on the effectiveness and safety data of nemolizumab in PN,” the authors wrote.
Source: Kwatra S, Stander S, Elmariah S, et al. The RE-UNITE-PN study design: a prospective, non-interventional, phase 4 study of nemolizumab for the treatment of prurigo nodularis. Presented at: 2026 Winter Clinical Hawaii, January 16-21, Maui.