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Using nemolizumab (Nemluvio) to treat moderate-to-severe prurigo nodularis in adults

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

Observational Galderma R&D · NCT06988618

This project tries nemolizumab (Nemluvio) in adults with moderate-to-severe prurigo nodularis to see if it reduces itching and symptoms by six months.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorGalderma R&D Industry-sponsored
Drugs / interventionsnemolizumab
Locations51 sites (Birmingham, Alabama and 50 other locations)
Trial IDNCT06988618 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, non-interventional study collecting real-world physician assessments and patient-reported outcomes over about 12 months in adults newly started on nemolizumab. Treatment decisions are made by the treating physician per local labeling and no extra clinic visits or tests are required beyond routine care. The primary effectiveness evaluation focuses on outcomes at Month 6 using investigator and patient-reported measures. A sub-study in selected German and UK sites will collect daily peak pruritus and sleep disturbance scores remotely for the first two weeks.

Who should consider this trial

Good fit: Adults (≥18 years) with prurigo nodularis who are newly initiated on nemolizumab by their treating physician and who can provide informed consent and complete study questionnaires.

Not a fit: Patients previously treated with nemolizumab, those with contraindications to the drug, those who received investigational drugs within three months, or those unable to complete consent/questionnaires are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could show nemolizumab reduces itch and improves sleep and symptom burden for adults with prurigo nodularis in routine clinical practice.

How similar studies have performed: Randomized clinical trials of nemolizumab for prurigo nodularis have reported reductions in itch and symptom measures, and this study aims to confirm those effects in routine practice.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prurigo Nodularis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.