Actively Recruiting
Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
Led by Galderma R&D · Updated on 2026-05-01
50
Participants Needed
24
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to assess the PK/PD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.
CONDITIONS
Official Title
Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- Chronic itching on normal-appearing skin (except dry skin or excoriations) for at least 6 months before screening.
- Chronic pruritus of unknown origin without association to other conditions or medications.
- Itching affects at least 4 of these body areas: left lower limb, right lower limb, left upper limb, right upper limb, anterior trunk, posterior trunk.
- History of inadequate control of chronic pruritus with prior treatments.
- Peak Pruritus Numeric Rating Scale (PP NRS) score of 7 or higher in the 24 hours before screening.
- Weekly average PP NRS score of 7 or higher in the 7 days before randomization.
- Female participants of childbearing potential must agree to use at least one approved method of contraception during the study and for 12 weeks after last injection.
- Females not of childbearing potential must either have no menstrual bleeding for 1 year confirmed by hormone levels or documented surgical sterilization at least 3 months before screening.
- Signed informed consent.
- Willingness and ability to comply with study procedures and time commitments.
You will not qualify if you...
- Known dermatologic, systemic, neurologic, or psychiatric condition (other than dry skin) causing current itching.
- Parasitic infection, including skin parasites like scabies, within 12 weeks before randomization.
- Skin infection within 1 week before baseline or any infection requiring treatment with antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before baseline.
- Diagnosis of chronic pruritus of neuropathic or psychogenic origin.
- Any medical or psychological condition or significant lab abnormalities putting participant at risk.
- History of bullous pemphigoid or positive bullous pemphigoid autoantibodies.
- History of mastocytosis or serum total tryptase greater than 20 ng/ml at screening.
- Active or incompletely treated tuberculosis or non-tuberculosis mycobacterial infection.
- Positive tests for hepatitis B or C, or HIV infection at screening.
- Known or suspected immunodeficiency.
- Lymphoproliferative disease or malignancy within last 5 years.
- Major psychiatric diagnosis, dementia, intellectual impairment, or conditions interfering with study compliance.
- Use of prohibited medications before baseline.
- Previous participation in a nemolizumab clinical study.
- Participation in other investigational drug or device studies within 8 weeks before screening.
- Body weight less than 30 kg.
- Prior treatment with commercially available nemolizumab.
- Allergy to nemolizumab or any study drug components.
- Need for rescue therapy for itching during screening.
- Alcohol or substance abuse within 6 months before screening.
- Planned major surgery or activities interfering with study assessments.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Vulnerable participants as defined by ICH GCP guidelines.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Galderma Investigational Site (site# 8893)
Birmingham, Alabama, United States, 35244
Actively Recruiting
2
Galderma Investigational Site (#8768)
Tucson, Arizona, United States, 85718
Not Yet Recruiting
3
Galderma Investigational Site (site# 8636)
Fountain Valley, California, United States, 92708
Actively Recruiting
4
Galderma Investigational Site (site# 8130)
Los Angeles, California, United States, 90045
Actively Recruiting
5
Galderma Investigational Site (#9975)
Sacramento, California, United States, 95815
Actively Recruiting
6
Galderma Investigational Site (site# 8021)
San Diego, California, United States, 92123
Not Yet Recruiting
7
Galderma Investigational Site (site# 7075)
San Francisco, California, United States, 94115
Actively Recruiting
8
Galderma Investigational Site (site# 8608)
Santa Monica, California, United States, 90404
Not Yet Recruiting
9
Galderma Investigational Site (#8295)
Miami, Florida, United States, 33136
Not Yet Recruiting
10
Galderma Investigational Site (site# 7054)
Tampa, Florida, United States, 33609
Actively Recruiting
11
Galderma Investigational Site (site# 8142)
Indianapolis, Indiana, United States, 46250
Not Yet Recruiting
12
Galderma Investigational Site (#7129)
Bowling Green, Kentucky, United States, 42104
Not Yet Recruiting
13
Galderma Investigational Site (site# 8743)
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
14
Galderma Investigational Site (site# 8521)
Saint Joseph, Missouri, United States, 64506
Not Yet Recruiting
15
Galderma Investigational Site (site# 8108)
Las Vegas, Nevada, United States, 89145
Actively Recruiting
16
Galderma Investigational Site (site# 7110)
New City, New York, United States, 10956
Actively Recruiting
17
Galderma Investigational Site (#7130)
The Bronx, New York, United States, 10455
Not Yet Recruiting
18
Galderma Investigational Site (site# 7111)
Fargo, North Dakota, United States, 58103
Actively Recruiting
19
Galderma Investigational Site (#8212)
Portland, Oregon, United States, 97210
Not Yet Recruiting
20
Galderma Investigational Site (#8255)
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
21
Galderma Investigational Site (site# 8003)
Webster, Texas, United States, 77598
Actively Recruiting
22
Galderma Investigational Site (site# 8862)
Fairfax, Virginia, United States, 22031
Actively Recruiting
23
Galderma Investigational Site (site# 8725)
Morgantown, West Virginia, United States, 26505
Actively Recruiting
24
Galderma Investigational Site (site# 8045)
Québec, Quebec, Canada, G1V 4X7
Not Yet Recruiting
Research Team
G
Galderma Research and Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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