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NCT06988618Recruiting

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

Galderma R&D

Start Date

8/11/2025

Completion Date

11/30/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Prurigo Nodularis

Locations

Galderma Investigational Site # 8893

Birmingham, Alabama 35244

United States

Galderma Investigational Site # 7077

Phoenix, Arizona 85006-2754

United States

Galderma Investigational Site # 7060

Phoenix, Arizona 85008-3884

United States

Galderma Investigational Site # 7067

Tucson, Arizona 85718

United States

Galderma Investigational Site # 7074

Corona, California 92882

United States

Galderma Investigational Site # 6836

Fountain Valley, California 92708-3701

United States

Galderma Investigational Site # 8224

Fremont, California 94538-1603

United States

Galderma Investigational Site # 7064

Santa Monica, California 90404-2216

United States

Galderma Investigational Site # 7061

Castle Rock, Colorado 80109-8034

United States

Galderma Investigational Site # 7059

Fairfield, Connecticut 06824

United States

Galderma Investigational Site # 7087

Coral Gables, Florida 33134

United States

Galderma Investigational Site # 7063

Cutler Bay, Florida 33157

United States

Galderma Investigational Site # 7078

Miami, Florida 33173

United States

Galderma Investigational Site # 7070

North Miami Beach, Florida 33162-4708

United States

Galderma Investigational Site # 7091

Tampa, Florida 33615-4537

United States

Galderma Investigational Site # 7058

Chicago, Illinois 60641

United States

Galderma Investigational Site # 8142

Indianapolis, Indiana 46250-2041

United States

Galderma Investigational Site # 8012

Glendale, Maryland 20769-9182

United States

Galderma Investigational Site # 7068

Rockville, Maryland 20850-6243

United States

Galderma Investigational Site # 7065

Brighton, Massachusetts 02135

United States

Galderma Investigational Site # 7066

Auburn Hills, Michigan 48326-3396

United States

Galderma Investigational Site # 7071

Caledonia, Michigan 49316-7478

United States

Galderma Investigational Site # 7072

Troy, Michigan 48084-5260

United States

Galderma Investigational Site # 7053

Waterford, Michigan 48328

United States

Galderma Investigational Site # 7057

Lee's Summit, Missouri 64064

United States

Galderma Investigational Site # 7076

St Louis, Missouri 63141-7068

United States

Galderma Investigational Site # 7055

Portsmouth, New Hampshire 03801-7156

United States

Galderma Investigational Site # 7080

Auburn, New York 13021

United States

Galderma Investigational Site # 7052

East Syracuse, New York 13057

United States

Galderma Investigational Site # 8282

Mount Kisco, New York 10549-3035

United States

Galderma Investigational Site # 7056

New York, New York 10012-1354

United States

Galderma Investigational Site # 7051

New York, New York 10023

United States

Galderma Investigational Site # 7081

Dayton, Ohio 45414-2799

United States

Galderma Investigational Site # 8559

Philadelphia, Pennsylvania 19103-4738

United States

Galderma Investigational Site # 8238

Dallas, Texas 75230-5808

United States

Galderma Investigational Site # 7062

Edinburg, Texas 78539-4660

United States

Galderma Investigational Site # 7088

Grapevine, Texas 76051

United States

Galderma Investigational Site # 7069

Sugar Land, Texas 77478-3842

United States

Galderma Investigational Site # 7079

Vienna, Virginia 22182

United States

Galderma Investigational Site # 6374

Karlsruhe, Baden-Wurttemberg 76133

Germany

Galderma Investigational Site # 6369

Erlangen, Bavaria 91054

Germany

Galderma Investigation Site # 6367

Rostock, Mecklenburg-Vorpommern 18057

Germany

Galderma Investigational Site # 5437

Kiel, Schleswig-Holstein 24105

Germany

Galderma Investigational Site # 6387

Ahaus, 48683

Germany

Galderma Investigational Site # 6385

Berlin, 10117

Germany

Galderma Investigational Tracker Site # 6172

Berlin, 12203

Germany

Galderma Investigational Site # 6386

Bielefeld, 33647

Germany

Galderma Investigational Site # 6370

Haslach, 77716

Germany

Galderma Investigational Site # 6384

Koblenz, 56068

Germany

Galderma Investigational Site # 6373

Mainz, 55128

Germany

Galderma Investigational Site # 6371

Oberursel, 61440

Germany