Recruiting

Nemolizumab

Sponsor:

Galderma R&D

Code:

NCT06988618

Conditions

Prurigo Nodularis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Prurigo Nodularis

Study ID

NCT06988618

Start date

Aug 11, 2025

Status verified date

Sep, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Nemolizumab

Participants with moderate-to-severe PN who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months.

Primary outcome measure

  • Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6 [ Time Frame: At 6 month ]
  • Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6 [ Time Frame: At 6 month ]

Central Contacts and Locations

Central contacts

Galderma Research and Development

817-961-5000clinical.studies@galderma.com

Locations

Galderma Investigational Site # 8893

Recruiting

Birmingham, Alabama, United States, 35244

Galderma Investigational Site # 7077

Recruiting

Phoenix, Arizona, United States, 85006-2754

Galderma Investigational Site # 7060

Recruiting

Phoenix, Arizona, United States, 85008-3884

Galderma Investigational Site # 7067

Recruiting

Tucson, Arizona, United States, 85718

Galderma Investigational Site # 7074

Recruiting

Corona, California, United States, 92882

Galderma Investigational Site # 6836

Recruiting

Fountain Valley, California, United States, 92708-3701

Galderma Investigational Site # 8224

Recruiting

Fremont, California, United States, 94538-1603

Galderma Investigational Site # 7064

Recruiting

Santa Monica, California, United States, 90404-2216

Galderma Investigational Site # 7061

Recruiting

Castle Rock, Colorado, United States, 80109-8034

Galderma Investigational Site # 7059

Recruiting

Fairfield, Connecticut, United States, 06824

Galderma Investigational Site # 7087

Recruiting

Coral Gables, Florida, United States, 33134

Galderma Investigational Site # 7063

Recruiting

Cutler Bay, Florida, United States, 33157

Galderma Investigational Site # 7078

Recruiting

Miami, Florida, United States, 33173

Galderma Investigational Site # 7070

Recruiting

North Miami Beach, Florida, United States, 33162-4708

Galderma Investigational Site # 7091

Recruiting

Tampa, Florida, United States, 33615-4537

Galderma Investigational Site # 8142

Recruiting

Indianapolis, Indiana, United States, 46250-2041

Galderma Investigational Site # 8012

Recruiting

Glendale, Maryland, United States, 20769-9182

Galderma Investigational Site # 7068

Recruiting

Rockville, Maryland, United States, 20850-6243

Galderma Investigational Site # 7065

Recruiting

Brighton, Massachusetts, United States, 02135

Galderma Investigational Site # 7066

Recruiting

Auburn Hills, Michigan, United States, 48326-3396

Galderma Investigational Site # 7071

Recruiting

Caledonia, Michigan, United States, 49316-7478

Galderma Investigational Site # 7072

Recruiting

Troy, Michigan, United States, 48084-5260

Galderma Investigational Site # 7053

Recruiting

Waterford, Michigan, United States, 48328

Galderma Investigational Site # 7057

Recruiting

Lee's Summit, Missouri, United States, 64064

Galderma Investigational Site # 7076

Recruiting

St Louis, Missouri, United States, 63141-7068

Galderma Investigational Site # 7055

Recruiting

Portsmouth, New Hampshire, United States, 03801-7156

Galderma Investigational Site # 7080

Recruiting

Auburn, New York, United States, 13021

Galderma Investigational Site # 7052

Recruiting

East Syracuse, New York, United States, 13057

Galderma Investigational Site # 8282

Recruiting

Mount Kisco, New York, United States, 10549-3035

Galderma Investigational Site # 7056

Recruiting

New York, New York, United States, 10012-1354

Galderma Investigational Site # 7051

Recruiting

New York, New York, United States, 10023

Galderma Investigational Site # 7081

Recruiting

Dayton, Ohio, United States, 45414-2799

Galderma Investigational Site # 8559

Recruiting

Philadelphia, Pennsylvania, United States, 19103-4738

Galderma Investigational Site # 8238

Recruiting

Dallas, Texas, United States, 75230-5808

Galderma Investigational Site # 7062

Recruiting

Edinburg, Texas, United States, 78539-4660

Galderma Investigational Site # 7088

Recruiting

Grapevine, Texas, United States, 76051

Galderma Investigational Site # 7069

Recruiting

Sugar Land, Texas, United States, 77478-3842

Galderma Investigational Site # 7079

Recruiting

Vienna, Virginia, United States, 22182

More Information

Sponsor

Galderma R&D

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Galderma R&D on 2026-09-09.