The RE-UNITE-PN Study Design – A Prospective, Non-Interventional, Phase 4 Study of Nemolizumab for the Treatment of Prurigo Nodularis

Introduction Prurigo nodularis (PN) is a chronic neuroimmune skin disease, characterized by debilitating itch and multiple pruriginous lesions. Nemolizumab, an interleukin-31 receptor alpha antagonist, demonstrated efficacy and safety in patients with PN in OLYMPIA 1&2 phase 3 randomized clinical trials. Following its regulatory approval by several regulatory authorities worldwide, including USFDA and EMA, nemolizumab is now available for clinical use in many countries, enabling the initiation of a non-interventional study (NIS) to evaluate its effectiveness and safety in a real-world setting. Objective: To report key design features of RE-UNITE-PN study. Methods RE-UNITE-PN (NCT06988618) is a prospective, multicenter, phase 4, NIS in adults with PN newly initiated on nemolizumab for the treatment of PN according to the treating physician’s decision and in line with local package labels. Approximately 600 participants will be enrolled across 150 study sites in North America and Europe. Patients who have contraindication(s) for the use of nemolizumab according to the local package label and/or have received treatment during clinical development/investigation within 3 months prior to baseline are not eligible. Primary endpoints will assess Investigator’s Global Assessment-chronic prurigo (IGA-CPG) and Peak Pruritus Numerical Rating Scale (PP-NRS) score in clinical practice at month 6. Secondary endpoints will assess additional metrics on IGA-CPG 0/1, prurigo activity and severity score (PAS score), PP-NRS score, and Sleep Disturbance NRS score up to month 12. Other PROs include quality of life and treatment satisfaction up to month 12. The incidence of serious adverse events regardless of causality and non-serious adverse drug reactions will also be assessed. Conclusion This NIS, with large sample size and real-world design, is expected to help address data gaps from pivotal clinical trials and complement existing evidence on the effectiveness and safety data of nemolizumab in PN. By enrolling patients based on routine clinical decisions made independently by treating physicians, the study reflects everyday clinical practice and provides valuable insights into the real-world effectiveness and PROs associated with nemolizumab.