Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults (RE-UNITE PN)

Galderma

Status: Begins enrollment this month

Conditions: Prurigo Nodularis

Study type: Observational

Funder types: Industry

Identifiers

NCT06988618

SPR207807

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who, according to the treating physician's decision and in line with the local package label, are newly initiated on nemolizumab (Nemluvio®) for the treatment of PN.
• Participants greater than or equal to (>=) 18 years of age.
• Participants who signed the written informed consent form (ICF).

Exclusion criteria

• Have contraindication(s) for the use of nemolizumab (Nemluvio®) according to the local package label;
• Participants who received treatment with a drug under clinical development/ investigation within 3 months prior to baseline.
• Participants who received nemolizumab previously.
• Participants who are mentally, physically, or linguistically unable to understand the content of the ICF and/or to complete the study questionnaires.

Trial design

600 participants in 1 patient group

Nemolizumab

Description:

Participants with moderate-to-severe PN who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months.