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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Galderma R&D Industry-sponsored |
| Drugs / interventions | nemolizumab |
| Locations | 51 sites (Birmingham, Alabama and 50 other locations) |
| Status | Recruiting |
| Started | August 11, 2025 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT06988618 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
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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
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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
- Study coordinator: Galderma Research and Development
- Email: clinical.studies@galderma.com
- Phone: 817-961-5000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.