Status:
RECRUITING
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
Lead Sponsor:
Galderma R&D
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06988618
Start Date
August 11 2025
End Date
November 30 2027
Last Update
August 17 2025
Active Locations (51)
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1
Galderma Investigational Site # 8893
Birmingham, Alabama, United States, 35244
2
Galderma Investigational Site # 7077
Phoenix, Arizona, United States, 85006-2754
3
Galderma Investigational Site # 7060
Phoenix, Arizona, United States, 85008-3884
4
Galderma Investigational Site # 7067
Tucson, Arizona, United States, 85718