Clinical trial Recruiting at 49 sites Observational Ages 18 and up

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

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

Run by Galderma R&D · NCT06988618 · Data updated 2026-11-12

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

More Prurigo Nodularis trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorGalderma R&D
Industry-sponsored
Drugs / interventionsnemolizumab
Locations51 sites (Birmingham, Alabama and 50 other locations)
StatusRecruiting
StartedAugust 11, 2025
Main results expectedNovember 30, 2027
Study endsNovember 30, 2027
Registry record updatedSeptember 9, 2026
Trial IDNCT06988618 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Galderma Investigational Site # 8893
    Birmingham, Alabama, United States
    Recruiting
  • Galderma Investigational Site # 7077
    Phoenix, Arizona, United States
    Recruiting
  • Galderma Investigational Site # 7060
    Phoenix, Arizona, United States
    Recruiting
  • Galderma Investigational Site # 7067
    Tucson, Arizona, United States
    Recruiting
  • Galderma Investigational Site # 7074
    Corona, California, United States
    Recruiting
  • Galderma Investigational Site # 6836
    Fountain Valley, California, United States
    Recruiting
Show 44 more locations
  • Galderma Investigational Site # 8224
    Fremont, California, United States
    Recruiting
  • Galderma Investigational Site # 7064
    Santa Monica, California, United States
    Recruiting
  • Galderma Investigational Site # 7061
    Castle Rock, Colorado, United States
    Recruiting
  • Galderma Investigational Site # 7059
    Fairfield, Connecticut, United States
    Recruiting
  • Galderma Investigational Site # 7087
    Coral Gables, Florida, United States
    Recruiting
  • Galderma Investigational Site # 7063
    Cutler Bay, Florida, United States
    Recruiting
  • Galderma Investigational Site # 7078
    Miami, Florida, United States
    Recruiting
  • Galderma Investigational Site # 7070
    North Miami Beach, Florida, United States
    Recruiting
  • Galderma Investigational Site # 7091
    Tampa, Florida, United States
    Recruiting
  • Galderma Investigational Site # 8142
    Indianapolis, Indiana, United States
    Recruiting
  • Galderma Investigational Site # 8012
    Glendale, Maryland, United States
    Recruiting
  • Galderma Investigational Site # 7068
    Rockville, Maryland, United States
    Recruiting
  • Galderma Investigational Site # 7065
    Brighton, Massachusetts, United States
    Recruiting
  • Galderma Investigational Site # 7066
    Auburn Hills, Michigan, United States
    Recruiting
  • Galderma Investigational Site # 7071
    Caledonia, Michigan, United States
    Recruiting
  • Galderma Investigational Site # 7072
    Troy, Michigan, United States
    Recruiting
  • Galderma Investigational Site # 7053
    Waterford, Michigan, United States
    Recruiting
  • Galderma Investigational Site # 7057
    Lee's Summit, Missouri, United States
    Recruiting
  • Galderma Investigational Site # 7076
    St Louis, Missouri, United States
    Recruiting
  • Galderma Investigational Site # 7055
    Portsmouth, New Hampshire, United States
    Recruiting
  • Galderma Investigational Site # 7080
    Auburn, New York, United States
    Recruiting
  • Galderma Investigational Site # 7052
    East Syracuse, New York, United States
    Recruiting
  • Galderma Investigational Site # 8282
    Mount Kisco, New York, United States
    Recruiting
  • Galderma Investigational Site # 7056
    New York, New York, United States
    Recruiting
  • Galderma Investigational Site # 7051
    New York, New York, United States
    Recruiting
  • Galderma Investigational Site # 7081
    Dayton, Ohio, United States
    Recruiting
  • Galderma Investigational Site # 8559
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Galderma Investigational Site # 8238
    Dallas, Texas, United States
    Recruiting
  • Galderma Investigational Site # 7062
    Edinburg, Texas, United States
    Recruiting
  • Galderma Investigational Site # 7088
    Grapevine, Texas, United States
    Recruiting
  • Galderma Investigational Site # 7069
    Sugar Land, Texas, United States
    Recruiting
  • Galderma Investigational Site # 7079
    Vienna, Virginia, United States
    Recruiting
  • Galderma Investigational Site # 6374
    Karlsruhe, Baden-Wurttemberg, Germany
    Recruiting
  • Galderma Investigational Site # 6369
    Erlangen, Bavaria, Germany
    Recruiting
  • Galderma Investigation Site # 6367
    Rostock, Mecklenburg-Vorpommern, Germany
    Recruiting
  • Galderma Investigational Site # 5437
    Kiel, Schleswig-Holstein, Germany
    Recruiting
  • Galderma Investigational Site # 6387
    Ahaus, Germany
    Recruiting
  • Galderma Investigational Site # 6385
    Berlin, Germany
    Recruiting
  • Galderma Investigational Tracker Site # 6172
    Berlin, Germany
    Recruiting
  • Galderma Investigational Site # 6386
    Bielefeld, Germany
    Recruiting
  • Galderma Investigational Site # 6384
    Koblenz, Germany
    Recruiting
  • Galderma Investigational Site # 6373
    Mainz, Germany
    Recruiting
  • Galderma Investigational Site # 6371
    Oberursel, Germany
    Recruiting
  • Galderma Investigational Site # 7058
    Chicago, Illinois, United States
    Not yet recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.