NCT06988618

Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to assess real-world effectiveness of nemolizumab in Prurigo nodularis (PN) as measured by investigator and patient reported outcome (PRO) in clinical practice at Month 6.

Detailed description

This prospective, multicenter, non-interventional study (NIS) seeks to evaluate PN treatment with nemolizumab (Nemluvio®) in adults over an approximately 12 month period using physician assessments in routine clinical practice and PRO measures. Treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice. The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak pruritus (PP) numerical rating scale (NRS) and Sleep Disturbance (SD) NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely and no clinic visits will be required.

Conditions

• Prurigo Nodularis

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2025-05-25
• Last updated: 2026-03-12

Locations

51 sites across 2 countries: United States, Germany