Prurigo NodularisRE-UNITE PNNCT06988618
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
An observational study of Prurigo Nodularis, run by Galderma R&D at 51 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prurigo Nodularis
- How many people
- 600 participants
- Where
- 51 sitesin 2 countries
- Study dates
- 11 Aug 2025to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
51 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
51 sites in 2 countries
United States39 sites, 39 recruiting
- Recruiting
Galderma Investigational Site # 7080
Auburn, New York, 13021
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7066
Auburn Hills, Michigan, 48326-3396
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 8893
Birmingham, Alabama, 35244
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7065
Brighton, Massachusetts, 02135
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7071
Caledonia, Michigan, 49316-7478
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7061
Castle Rock, Colorado, 80109-8034
Clinical Project Manager
- Not yet recruiting
Galderma Investigational Site # 7058
Chicago, Illinois, 60641
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7087
Coral Gables, Florida, 33134
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7074
Corona, California, 92882
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7063
Cutler Bay, Florida, 33157
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 8238
Dallas, Texas, 75230-5808
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7081
Dayton, Ohio, 45414-2799
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7052
East Syracuse, New York, 13057
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7062
Edinburg, Texas, 78539-4660
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7059
Fairfield, Connecticut, 06824
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 6836
Fountain Valley, California, 92708-3701
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 8224
Fremont, California, 94538-1603
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 8012
Glendale, Maryland, 20769-9182
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7088
Grapevine, Texas, 76051
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 8142
Indianapolis, Indiana, 46250-2041
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7057
Lee's Summit, Missouri, 64064
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7078
Miami, Florida, 33173
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 8282
Mount Kisco, New York, 10549-3035
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7056
New York, New York, 10012-1354
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7051
New York, New York, 10023
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7070
North Miami Beach, Florida, 33162-4708
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 8559
Philadelphia, Pennsylvania, 19103-4738
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7077
Phoenix, Arizona, 85006-2754
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7060
Phoenix, Arizona, 85008-3884
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7055
Portsmouth, New Hampshire, 03801-7156
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7068
Rockville, Maryland, 20850-6243
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7064
Santa Monica, California, 90404-2216
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7076
St Louis, Missouri, 63141-7068
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7069
Sugar Land, Texas, 77478-3842
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7091
Tampa, Florida, 33615-4537
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7072
Troy, Michigan, 48084-5260
- Recruiting
Galderma Investigational Site # 7067
Tucson, Arizona, 85718
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7079
Vienna, Virginia, 22182
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 7053
Waterford, Michigan, 48328
Clinical Project Manager
Germany12 sites, 12 recruiting
- Recruiting
Galderma Investigational Site # 6387
Ahaus, 48683
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 6385
Berlin, 10117
Clinical Project Manager
- Recruiting
Galderma Investigational Tracker Site # 6172
Berlin, 12203
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 6386
Bielefeld, 33647
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 6369
Erlangen, Bavaria, 91054
Clinical Project Manager
- Not yet recruiting
Galderma Investigational Site # 6370
Haslach, 77716
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 6374
Karlsruhe, Baden-Wurttemberg, 76133
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 5437
Kiel, Schleswig-Holstein, 24105
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 6384
Koblenz, 56068
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 6373
Mainz, 55128
Clinical Project Manager
- Recruiting
Galderma Investigational Site # 6371
Oberursel, 61440
Clinical Project Manager
- Recruiting
Galderma Investigation Site # 6367
Rostock, Mecklenburg-Vorpommern, 18057
Clinical Project Manager
About this study
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.
Read the 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.
- Conditions
- Prurigo Nodularis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nemolizumab | Participants with moderate-to-severe PN who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 6 month
Secondary outcomes (4)
Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) Up to Month 12
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.
Measured: Up to 12 months
Prurigo Activity Score (PAS) Up to Month 12
The PAS is a physician-assessed tool to monitor the distribution and activity of chronic prurigo lesions. This includes a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. A higher score indicates higher level of activity.
Measured: Up to 12 months
Peak Pruritus Numerical Rating Scale (PP NRS) Up to Month 12
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.
Measured: Up to 12 months
Sleep Disturbance Numerical Rating Scale (SD NRS) Up to Month 12
The SD NRS is a single-item PRO for quantifying sleep disturbance that has been validated in PN participants. The SD NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)', how would you rate your sleep last night". Here, a lower score indicates a better outcome.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start11 Aug 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988618
- Sponsor's protocol ID
- SPR207807
- Acronym
- RE-UNITE PN
- Status last verified
- Sep 2026
- First submitted
- 16 May 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
- ClinicalTrials.gov ID
- NCT06988618
- Acronym / sponsor ID
- RE-UNITE PN / SPR207807
- Conditions
- Prurigo Nodularis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nemolizumab | – | –Participants with moderate-to-severe PN who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) Up to Month 12
Time frame: Up to 12 months
Prurigo Activity Score (PAS) Up to Month 12
Time frame: Up to 12 months
Peak Pruritus Numerical Rating Scale (PP NRS) Up to Month 12
Time frame: Up to 12 months
Sleep Disturbance Numerical Rating Scale (SD NRS) Up to Month 12
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prurigo Nodularis, run by Galderma R&D at 51 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galderma Research and Development (817-961-5000, clinical.studies@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6 (time frame: At 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.