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

NCT06988618 | Recruiting

• 1 other identifier: SPR207807
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 51

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

Outcome Measures

Primary Outcomes (2)

• Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6

  The IGA-CPG stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the physician. In this scale, nodules, papules, plaques, and other PN lesions are defined as pruriginous lesions or chronic prurigo lesions. A single score will be determined by the physician as follows: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), or 4 (severe). A higher score indicates severe chronic prurigo.

  At 6 month

• Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6

  The PP NRS is a single-question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.

  At 6 month

Secondary Outcomes (4)

• Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) Up to Month 12

  Up to 12 months

• Prurigo Activity Score (PAS) Up to Month 12

  Up to 12 months

• Peak Pruritus Numerical Rating Scale (PP NRS) Up to Month 12

  Up to 12 months

• Sleep Disturbance Numerical Rating Scale (SD NRS) Up to Month 12

  Up to 12 months

Study Arms (1)

Nemolizumab

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The clinical decision for treatment with nemolizumab has to be made by the physicians independently of the participation in this NIS and prior to the informed consent process. Participants greater than or equal to (\>=) 18 years of age will be eligible for the trial.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (51)

Galderma Investigational Site # 8893

Birmingham, Alabama, 35244, United States

NOT YET RECRUITING

Galderma Investigational Site # 7077

Phoenix, Arizona, 85006-2754, United States

NOT YET RECRUITING

Galderma Investigational Site # 7060

Phoenix, Arizona, 85008-3884, United States

NOT YET RECRUITING

Galderma Investigational Site # 7067

Tucson, Arizona, 85718, United States

NOT YET RECRUITING

Galderma Investigational Site # 7074

Corona, California, 92882, United States

NOT YET RECRUITING

Galderma Investigational Site # 6836

Fountain Valley, California, 92708-3701, United States

NOT YET RECRUITING

Galderma Investigational Site # 8224

Fremont, California, 94538-1603, United States

NOT YET RECRUITING

Galderma Investigational Site # 7064

Santa Monica, California, 90404-2216, United States

NOT YET RECRUITING

Galderma Investigational Site # 7061

Castle Rock, Colorado, 80109-8034, United States

NOT YET RECRUITING

Galderma Investigational Site # 7059

Fairfield, Connecticut, 06824, United States

NOT YET RECRUITING

Galderma Investigational Site # 7087

Coral Gables, Florida, 33134, United States

NOT YET RECRUITING

Galderma Investigational Site # 7063

Cutler Bay, Florida, 33157, United States

NOT YET RECRUITING

Galderma Investigational Site # 7078

Miami, Florida, 33173, United States

NOT YET RECRUITING

Galderma Investigational Site # 7070

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

NOT YET RECRUITING

Galderma Investigational Site # 7091

Tampa, Florida, 33615-4537, United States

NOT YET RECRUITING

Galderma Investigational Site # 7058

Chicago, Illinois, 60641, United States

NOT YET RECRUITING

Galderma Investigational Site # 8142

Indianapolis, Indiana, 46250-2041, United States

NOT YET RECRUITING

Galderma Investigational Site # 8012

Glendale, Maryland, 20769-9182, United States

NOT YET RECRUITING

Galderma Investigational Site # 7068

Rockville, Maryland, 20850-6243, United States

NOT YET RECRUITING

Galderma Investigational Site # 7065

Brighton, Massachusetts, 02135, United States

NOT YET RECRUITING

Galderma Investigational Site # 7066

Auburn Hills, Michigan, 48326-3396, United States

NOT YET RECRUITING

Galderma Investigational Site # 7071

Caledonia, Michigan, 49316-7478, United States

NOT YET RECRUITING

Galderma Investigational Site # 7072

Troy, Michigan, 48084-5260, United States

NOT YET RECRUITING

Galderma Investigational Site # 7053

Waterford, Michigan, 48328, United States

NOT YET RECRUITING

Galderma Investigational Site # 7057

Lee's Summit, Missouri, 64064, United States

NOT YET RECRUITING

Galderma Investigational Site # 7076

St Louis, Missouri, 63141-7068, United States

NOT YET RECRUITING

Galderma Investigational Site # 7055

Portsmouth, New Hampshire, 03801-7156, United States

RECRUITING

Galderma Investigational Site # 7080

Auburn, New York, 13021, United States

NOT YET RECRUITING

Galderma Investigational Site # 7052

East Syracuse, New York, 13057, United States

NOT YET RECRUITING

Galderma Investigational Site # 8282

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

NOT YET RECRUITING

Galderma Investigational Site # 7056

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

NOT YET RECRUITING

Galderma Investigational Site # 7051

New York, New York, 10023, United States

NOT YET RECRUITING

Galderma Investigational Site # 7081

Dayton, Ohio, 45414-2799, United States

NOT YET RECRUITING

Galderma Investigational Site # 8559

Philadelphia, Pennsylvania, 19103-4738, United States

NOT YET RECRUITING

Galderma Investigational Site # 8238

Dallas, Texas, 75230-5808, United States

NOT YET RECRUITING

Galderma Investigational Site # 7062

Edinburg, Texas, 78539-4660, United States

NOT YET RECRUITING

Galderma Investigational Site # 7088

Grapevine, Texas, 76051, United States

NOT YET RECRUITING

Galderma Investigational Site # 7069

Sugar Land, Texas, 77478-3842, United States

NOT YET RECRUITING

Galderma Investigational Site # 7079

Vienna, Virginia, 22182, United States

NOT YET RECRUITING

Galderma Investigational Site # 6374

Karlsruhe, Baden-Wurttemberg, 76133, Germany

NOT YET RECRUITING

Galderma Investigational Site # 6369

Erlangen, Bavaria, 91054, Germany

NOT YET RECRUITING

Galderma Investigation Site # 6367

Rostock, Mecklenburg-Vorpommern, 18057, Germany

NOT YET RECRUITING

Galderma Investigational Site # 5437

Kiel, Schleswig-Holstein, 24105, Germany

NOT YET RECRUITING

Galderma Investigational Site # 6387

Ahaus, 48683, Germany

NOT YET RECRUITING

Galderma Investigational Site # 6385

Berlin, 10117, Germany

NOT YET RECRUITING

Galderma Investigational Tracker Site # 6172

Berlin, 12203, Germany

NOT YET RECRUITING

Galderma Investigational Site # 6386

Bielefeld, 33647, Germany

NOT YET RECRUITING

Galderma Investigational Site # 6370

Haslach, 77716, Germany

NOT YET RECRUITING

Galderma Investigational Site # 6384

Koblenz, 56068, Germany

NOT YET RECRUITING

Galderma Investigational Site # 6373

Mainz, 55128, Germany

NOT YET RECRUITING

Galderma Investigational Site # 6371

Oberursel, 61440, Germany

NOT YET RECRUITING

Central Study Contacts

Galderma Research and Development

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 12, 2026

Record last verified: 2025-08

Locations

US (39); DE (12)