Actively Recruiting
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to-Severe Prurigo Nodularis in Adults
Led by Galderma R&D · Updated on 2026-06-01
600
Participants Needed
51
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the real-world effectiveness of nemolizumab in adults with moderate-to-severe Prurigo nodularis (PN), a chronic skin condition. This observational study aims to assess outcomes reported by both investigators and patients over six months, focusing on how the treatment works in routine clinical practice. The study follows adults newly prescribed nemolizumab by their physicians. Participants will be observed for about 12 months while receiving treatment as part of their regular medical care. No extra visits, procedures, or lab tests beyond usual clinical practice are required. A sub-study in Germany and the UK will have some participants record their itch intensity and sleep disturbance daily for the first two weeks through remote data collection. Participants will have routine clinical visits determined by their doctors, with data collected during these visits. Researchers will assess outcomes such as the Investigator Global Assessment of chronic prurigo and patient-reported peak itch intensity at six months and up to 12 months. Sleep disturbance and prurigo activity will also be tracked. This approach allows long-term monitoring of treatment effects in a real-world setting without added study-related procedures.
CONDITIONS
Brief Title
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants newly prescribed nemolizumab for Prurigo nodularis by their treating physician
- Adults aged 18 years or older
- Participants who have signed the written informed consent form
You will not qualify if you...
- Contraindications for nemolizumab use according to local guidelines
- Use of investigational drugs within 3 months before baseline
- Previous treatment with nemolizumab
- Inability to understand informed consent or complete study questionnaires due to mental, physical, or language barriers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately 12 months
Participants who undergo routine care with nemolizumab for moderate-to-severe Prurigo Nodularis are observed over approximately 12 months through physician assessments and patient-reported outcome measures.
Visits occur according to routine clinical practice without additional study visits
Duration - 15 days
Participants in a sub-study complete daily Peak Pruritus and Sleep Disturbance rating scales remotely for the first 15 days to capture detailed symptom data.
Daily remote data collection from Day -1 to Day 14
Trial Site Locations
Total: 51 locations
1
Galderma Investigational Site # 8893
Birmingham, Alabama, United States, 35244
Not Yet Recruiting
2
Galderma Investigational Site # 7077
Phoenix, Arizona, United States, 85006-2754
Not Yet Recruiting
3
Galderma Investigational Site # 7060
Phoenix, Arizona, United States, 85008-3884
Not Yet Recruiting
4
Galderma Investigational Site # 7067
Tucson, Arizona, United States, 85718
Not Yet Recruiting
5
Galderma Investigational Site # 7074
Corona, California, United States, 92882
Not Yet Recruiting
6
Galderma Investigational Site # 6836
Fountain Valley, California, United States, 92708-3701
Actively Recruiting
7
Galderma Investigational Site # 8224
Fremont, California, United States, 94538-1603
Not Yet Recruiting
8
Galderma Investigational Site # 7064
Santa Monica, California, United States, 90404-2216
Not Yet Recruiting
9
Galderma Investigational Site # 7061
Castle Rock, Colorado, United States, 80109-8034
Not Yet Recruiting
10
Galderma Investigational Site # 7059
Fairfield, Connecticut, United States, 06824
Not Yet Recruiting
11
Galderma Investigational Site # 7087
Coral Gables, Florida, United States, 33134
Not Yet Recruiting
12
Galderma Investigational Site # 7063
Cutler Bay, Florida, United States, 33157
Not Yet Recruiting
13
Galderma Investigational Site # 7078
Miami, Florida, United States, 33173
Not Yet Recruiting
14
Galderma Investigational Site # 7070
North Miami Beach, Florida, United States, 33162-4708
Not Yet Recruiting
15
Galderma Investigational Site # 7091
Tampa, Florida, United States, 33615-4537
Not Yet Recruiting
16
Galderma Investigational Site # 7058
Chicago, Illinois, United States, 60641
Not Yet Recruiting
17
Galderma Investigational Site # 8142
Indianapolis, Indiana, United States, 46250-2041
Not Yet Recruiting
18
Galderma Investigational Site # 8012
Glendale, Maryland, United States, 20769-9182
Not Yet Recruiting
19
Galderma Investigational Site # 7068
Rockville, Maryland, United States, 20850-6243
Not Yet Recruiting
20
Galderma Investigational Site # 7065
Brighton, Massachusetts, United States, 02135
Not Yet Recruiting
21
Galderma Investigational Site # 7066
Auburn Hills, Michigan, United States, 48326-3396
Not Yet Recruiting
22
Galderma Investigational Site # 7071
Caledonia, Michigan, United States, 49316-7478
Not Yet Recruiting
23
Galderma Investigational Site # 7072
Troy, Michigan, United States, 48084-5260
Not Yet Recruiting
24
Galderma Investigational Site # 7053
Waterford, Michigan, United States, 48328
Not Yet Recruiting
25
Galderma Investigational Site # 7057
Lee's Summit, Missouri, United States, 64064
Not Yet Recruiting
26
Galderma Investigational Site # 7076
St Louis, Missouri, United States, 63141-7068
Not Yet Recruiting
27
Galderma Investigational Site # 7055
Portsmouth, New Hampshire, United States, 03801-7156
Actively Recruiting
28
Galderma Investigational Site # 7080
Auburn, New York, United States, 13021
Not Yet Recruiting
29
Galderma Investigational Site # 7052
East Syracuse, New York, United States, 13057
Not Yet Recruiting
30
Galderma Investigational Site # 8282
Mount Kisco, New York, United States, 10549-3035
Not Yet Recruiting
31
Galderma Investigational Site # 7056
New York, New York, United States, 10012-1354
Not Yet Recruiting
32
Galderma Investigational Site # 7051
New York, New York, United States, 10023
Not Yet Recruiting
33
Galderma Investigational Site # 7081
Dayton, Ohio, United States, 45414-2799
Not Yet Recruiting
34
Galderma Investigational Site # 8559
Philadelphia, Pennsylvania, United States, 19103-4738
Not Yet Recruiting
35
Galderma Investigational Site # 8238
Dallas, Texas, United States, 75230-5808
Not Yet Recruiting
36
Galderma Investigational Site # 7062
Edinburg, Texas, United States, 78539-4660
Not Yet Recruiting
37
Galderma Investigational Site # 7088
Grapevine, Texas, United States, 76051
Not Yet Recruiting
38
Galderma Investigational Site # 7069
Sugar Land, Texas, United States, 77478-3842
Not Yet Recruiting
39
Galderma Investigational Site # 7079
Vienna, Virginia, United States, 22182
Not Yet Recruiting
40
Galderma Investigational Site # 6374
Karlsruhe, Baden-Wurttemberg, Germany, 76133
Not Yet Recruiting
41
Galderma Investigational Site # 6369
Erlangen, Bavaria, Germany, 91054
Not Yet Recruiting
42
Galderma Investigation Site # 6367
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Actively Recruiting
43
Galderma Investigational Site # 5437
Kiel, Schleswig-Holstein, Germany, 24105
Not Yet Recruiting
44
Galderma Investigational Site # 6387
Ahaus, Germany, 48683
Not Yet Recruiting
45
Galderma Investigational Site # 6385
Berlin, Germany, 10117
Actively Recruiting
46
Galderma Investigational Tracker Site # 6172
Berlin, Germany, 12203
Actively Recruiting
47
Galderma Investigational Site # 6386
Bielefeld, Germany, 33647
Actively Recruiting
48
Galderma Investigational Site # 6370
Haslach, Germany, 77716
Not Yet Recruiting
49
Galderma Investigational Site # 6384
Koblenz, Germany, 56068
Actively Recruiting
50
Galderma Investigational Site # 6373
Mainz, Germany, 55128
Actively Recruiting
51
Galderma Investigational Site # 6371
Oberursel, Germany, 61440
Actively Recruiting
Research Team
G
Galderma Research and Development
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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