NCT06988618 · Galderma R&D
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
(RE-UNITE PN)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6
Time frame: At 6 month
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.
Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6
Time frame: At 6 month
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Corona, California
- Fountain Valley, California
- Fremont, California
- Santa Monica, California
- Castle Rock, Colorado
- Fairfield, Connecticut
- Coral Gables, Florida
- Cutler Bay, Florida
- Miami, Florida
And 25 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations