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

Last updated: March 11, 2026
Sponsor: Galderma R&D
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atopic Dermatitis

Eczema (Atopic Dermatitis - Pediatric)

Warts

Treatment

N/A

Clinical Study ID

NCT06988618
SPR207807
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who, according to the treating physician's decision and in line withthe local package label, are newly initiated on nemolizumab (Nemluvio®) for thetreatment of PN.

  • Participants greater than or equal to (>=) 18 years of age.

  • Participants who signed the written informed consent form (ICF).

Exclusion

Exclusion Criteria:

  • Have contraindication(s) for the use of nemolizumab (Nemluvio®) according to thelocal 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 understandthe content of the ICF and/or to complete the study questionnaires.

Study Design

Total Participants: 600
Study Start date:
August 11, 2025
Estimated Completion Date:
November 30, 2027

Study 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.

Connect with a study center

  • Galderma Investigational Site # 6374

    Karlsruhe, Baden-Wurttemberg 76133
    Germany

    Site Not Available

  • Galderma Investigational Site # 6369

    Erlangen, Bavaria 91054
    Germany

    Site Not Available

  • Galderma Investigation Site # 6367

    Rostock, Mecklenburg-Vorpommern 18057
    Germany

    Site Not Available

  • Galderma Investigational Site # 5437

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Galderma Investigational Site # 6387

    Ahaus, 48683
    Germany

    Site Not Available

  • Galderma Investigational Site # 6385

    Berlin, 10117
    Germany

    Site Not Available

  • Galderma Investigational Tracker Site # 6172

    Berlin, 12203
    Germany

    Site Not Available

  • Galderma Investigational Site # 6386

    Bielefeld, 33647
    Germany

    Site Not Available

  • Galderma Investigational Site # 6370

    Haslach, 77716
    Germany

    Site Not Available

  • Galderma Investigational Site # 6384

    Koblenz, 56068
    Germany

    Site Not Available

  • Galderma Investigational Site # 6373

    Mainz, 55128
    Germany

    Site Not Available

  • Galderma Investigational Site # 6371

    Oberursel, 61440
    Germany

    Site Not Available

  • Galderma Investigational Site # 8893

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Galderma Investigational Site # 7060

    Phoenix, Arizona 85008-3884
    United States

    Site Not Available

  • Galderma Investigational Site # 7077

    Phoenix, Arizona 85006-2754
    United States

    Site Not Available

  • Galderma Investigational Site # 7067

    Tucson, Arizona 85718
    United States

    Site Not Available

  • Galderma Investigational Site # 7074

    Corona, California 92882
    United States

    Site Not Available

  • Galderma Investigational Site # 6836

    Fountain Valley, California 92708-3701
    United States

    Site Not Available

  • Galderma Investigational Site # 8224

    Fremont, California 94538-1603
    United States

    Site Not Available

  • Galderma Investigational Site # 7064

    Santa Monica, California 90404-2216
    United States

    Site Not Available

  • Galderma Investigational Site # 7061

    Castle Rock, Colorado 80109-8034
    United States

    Site Not Available

  • Galderma Investigational Site # 7059

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Galderma Investigational Site # 7087

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Galderma Investigational Site # 7063

    Cutler Bay, Florida 33157
    United States

    Site Not Available

  • Galderma Investigational Site # 7078

    Miami, Florida 33173
    United States

    Site Not Available

  • Galderma Investigational Site # 7070

    North Miami Beach, Florida 33162-4708
    United States

    Site Not Available

  • Galderma Investigational Site # 7091

    Tampa, Florida 33615-4537
    United States

    Site Not Available

  • Galderma Investigational Site # 7058

    Chicago, Illinois 60641
    United States

    Site Not Available

  • Galderma Investigational Site # 8142

    Indianapolis, Indiana 46250-2041
    United States

    Site Not Available

  • Galderma Investigational Site # 8012

    Glendale, Maryland 20769-9182
    United States

    Site Not Available

  • Galderma Investigational Site # 7068

    Rockville, Maryland 20850-6243
    United States

    Site Not Available

  • Galderma Investigational Site # 7065

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Galderma Investigational Site # 7066

    Auburn Hills, Michigan 48326-3396
    United States

    Site Not Available

  • Galderma Investigational Site # 7071

    Caledonia, Michigan 49316-7478
    United States

    Site Not Available

  • Galderma Investigational Site # 7072

    Troy, Michigan 48084-5260
    United States

    Site Not Available

  • Galderma Investigational Site # 7053

    Waterford, Michigan 48328
    United States

    Site Not Available

  • Galderma Investigational Site # 7057

    Lee's Summit, Missouri 64064
    United States

    Site Not Available

  • Galderma Investigational Site # 7076

    Saint Louis, Missouri 63141-7068
    United States

    Site Not Available

  • Galderma Investigational Site # 7076

    St Louis, Missouri 63141-7068
    United States

    Site Not Available

  • Galderma Investigational Site # 7055

    Portsmouth, New Hampshire 03801-7156
    United States

    Active - Recruiting

  • Galderma Investigational Site # 7080

    Auburn, New York 13021
    United States

    Site Not Available

  • Galderma Investigational Site # 7052

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Galderma Investigational Site # 8282

    Mount Kisco, New York 10549-3035
    United States

    Site Not Available

  • Galderma Investigational Site # 7051

    New York, New York 10023
    United States

    Site Not Available

  • Galderma Investigational Site # 7056

    New York, New York 10012-1354
    United States

    Site Not Available

  • Galderma Investigational Site # 7081

    Dayton, Ohio 45414-2799
    United States

    Site Not Available

  • Galderma Investigational Site # 8559

    Philadelphia, Pennsylvania 19103-4738
    United States

    Site Not Available

  • Galderma Investigational Site # 8238

    Dallas, Texas 75230-5808
    United States

    Site Not Available

  • Galderma Investigational Site # 7062

    Edinburg, Texas 78539-4660
    United States

    Site Not Available

  • Galderma Investigational Site # 7088

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Galderma Investigational Site # 7069

    Sugar Land, Texas 77478-3842
    United States

    Site Not Available

  • Galderma Investigational Site # 7079

    Vienna, Virginia 22182
    United States

    Site Not Available

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