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Chronic Pruritus of Unknown OriginPhase 2CPUONCT07074977

Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)

A Phase 2 study testing nemolizumab in people with Chronic Pruritus of Unknown Origin, run by Galderma R&D at 26 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pruritus of Unknown Origin
What is being tested?
nemolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
26 sitesin 2 countries
Study dates
20 Oct 2025to Jan 2027
Phase
Phase 2

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

Who may be able to join

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Participant must be 18 years of age or older.
  • Participants with chronic pruritus on normal-appearing skin (except for dry skin or excoriations) for at least 6 months before the screening visit.
  • Chronic pruritus considered of unknown origin (i.e., without a clear association to another condition or medication) as assessed by the investigator at baseline.
  • The pruritus must affect at least 4 of the following body areas: left lower limb, right lower limb, left upper limb, right upper limb, anterior trunk, posterior trunk.
  • History of insufficient control of the chronic pruritus with prior treatment.
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  • Peak Pruritus Numeric Rating Scale (PP NRS) score greater than and equal to (>=) 7 in the 24-hour period prior to the Screening visit.
  • Weekly average Peak Pruritus Numeric Rating Scale (PP NRS) score >= 7 in the week (7 days) immediately prior to randomization, as recorded in the patient diary.
  • Female of childbearing potential must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study intervention injection.
  • Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Females of non-childbearing potential must meet 1 of the following criteria:
  • Absence of menstrual bleeding for 1 year prior to screening without any other medical reason, confirmed with follicle stimulating hormone (FSH) level in the postmenopausal range
  • Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before screening 10. Signed informed consent. 11. Participant is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply :
  • Medical Conditions
  • Known dermatologic, systemic, neurologic or psychiatric condition(s), other than dry skin, that considered by the investigator to be the primary cause of current pruritus.
  • Documented parasitic infection, including skin parasites such as scabies, within 12 weeks prior randomization.
  • Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
  • Diagnosis of chronic pruritus of neuropathic origin including but not limited to scalp dysesthesia, brachioradial pruritus, generalized neuropathic pruritus or chronic pruritus of psychogenic origin (pruritus associated with psychological disorders such as delusional parasitosis or Morgellons disease).
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  • Any medical or psychological condition or any clinically relevant laboratory abnormalities that put the participant at significant risk.
  • History of bullous pemphigoid or positive bullous pemphigoid autoantibodies at screening.
  • History of mastocytosis or serum total tryptase greater than (>) 20 nanograms per milliliter (ng/ml) at screening.
  • Active tuberculosis (TB) or non-tuberculosis mycobacterial infection, or a history of incompletely treated TB.
  • Positive serology results Hepatitis B surface antigen or (HBsAg) or Antibody to Hepatitis B core antigen (HBcAb), Hepatitis C virus (HCV) antibody with positive confirmatory test for HCV (e.g., polymerase chain reaction [PCR]), or Human Immunodeficiency Virus [HIV] antibody) at the screening visit.
  • Known or suspected immunodeficiency.
  • Lymphoproliferative disease or malignancy within the last 5 years.
  • Presence of major psychiatric diagnosis, clinically significant dementia, intellectual impairment, or any medical condition or disability which, in the investigator's opinion, may confound the assessment of nemolizumab's safety or efficacy or interfere with the participant's ability to comply with protocol mandated activities.
  • Receipt of prohibited medications within the specified timeframe before the baseline visit
  • Previous participation in a clinical study with nemolizumab
  • Currently participating or participated in any other study of an investigational drug or device, within the past 8 weeks (or 5 half-lives of the investigational drug, whichever is longer) before the screening visit, or is in an exclusion period (if verifiable) from a previous study.
  • Body weight < 30 kg.
  • Prior treatment with commercially available nemolizmab
  • Hypersensitivity to the active substance (nemolizumab) or to any of the excipients of the study intervention.
  • Requiring rescue therapy for pruritus during the screening period.
  • Alcohol or substance abuse within 6 months of the screening visit.
  • Planned or anticipated major surgical procedure or other activity that would interfere with the participant's ability to comply with protocol-mandated assessments.
  • Pregnant or breastfeeding female, or female planning a pregnancy during the study.
  • Vulnerable participant as defined by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP).
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States25 sites

  • Galderma Investigational Site (site# 8743)

    Ann Arbor, Michigan, 48109

  • Galderma Investigational (Site# 7048)

    Baltimore, Maryland, 21201

  • Galderma Investigational Site (site# 8893)

    Birmingham, Alabama, 35244

  • Galderma Investigational Site (#7129)

    Bowling Green, Kentucky, 42104

  • Galderma Investigational Site (site# 8862)

    Fairfax, Virginia, 22031

  • Galderma Investigational Site (site# 7111)

    Fargo, North Dakota, 58103

  • Galderma Investigational Site (site# 8636)

    Fountain Valley, California, 92708

  • Galderma Investigational Site (site# 8142)

    Indianapolis, Indiana, 46250

  • Galderma Investigational Site (site# 8108)

    Las Vegas, Nevada, 89145

  • Galderma Investigational Site (site# 8130)

    Los Angeles, California, 90045

  • Galderma Investigational Site (#8295)

    Miami, Florida, 33136

  • Galderma Investigational Site (site# 8725)

    Morgantown, West Virginia, 26505

  • Galderma Investigational Site (site# 7110)

    New City, New York, 10956

  • Galderma Investigational Site (#8255)

    Philadelphia, Pennsylvania, 19103

  • Galderma Investigational Site (#8212)

    Portand, Oregon, 97210

  • Galderma Investigational Site (#9975)

    Sacramento, California, 95815

  • Galderma Investigational Site (site# 8521)

    Saint Joseph, Missouri, 64506

  • Galderma Investigational Site (site# 8021)

    San Diego, California, 92123

  • Galderma Investigational Site (site# 7075)

    San Francisco, California, 94115

  • Galderma Investigational Site (site# 8608)

    Santa Monica, California, 90404

  • Galderma Investigational (Site # 7131)

    Spartanburg, South Carolina, 29307

  • Galderma Investigational Site (site# 7054)

    Tampa, Florida, 33609

  • Galderma Investigational Site (#7130)

    The Bronx, New York, 10455

  • Galderma Investigational Site (#8768)

    Tucson, Arizona, 85718

  • Galderma Investigational Site (site# 8003)

    Webster, Texas, 77598

Other trials in United States

Canada1 site

  • Galderma Investigational Site (site# 8045)

    Québec, Quebec, G1V 4X7

Other trials in Canada

About this study

Official title: An Exploratory Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics (PK/PD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)

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.

Read the detailed description

This study is to assess the PK/PD relationship of nemolizumab in adult participants with CPUO. The study will consist of a 2 to 4-week screening period, a 16-week treatment period, and an 8-week follow up period (12 weeks after last study drug injection). Participants will be randomized 4:1 to nemolizumab or placebo. Dosing will be adjusted according to participants body weight ( less than [<] 90 kilograms [kg] versus >= 90 kg). Participation in the study will last up to 28 weeks.

Being tested
nemolizumab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nemolizumabDrug

    Also called CD14152

    Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.

  • PlaceboDrug

    Participants will receive matching placebo as SC injection.

Study groups in NCT07074977
Study groupRoleWhat they receive
nemolizumabExperimentalParticipants weighing < 90 kg will receive one subcutaneous (SC) injection of 30 milligrams (mg) nemolizumab (with 60 mg loading dose at baseline) every 4 weeks (Q4W) at Weeks 4, 8, and 12. Participants weighing >= 90 kg will receive two SC injections of 30 mg nemolizumab ( 60 mg total) at baseline (without loading dose) and at Weeks 4, 8, and 12.
Receives: Drug: nemolizumab
PlaceboPlacebo comparatorParticipants weighing < 90 kg will receive two SC injections of matching placebo at baseline followed by 1 SC injection Q4W at Weeks 4, 8 and 12. Participants weighing >= 90 kg will receive two SC injections of matching placebo at baseline and at Weeks 4, 8, and 12.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Population Pharmacokinetics (PopPK) Model of the Elimination of nemolizumab During the 16-week Treatment Period Point

    Point Estimate of Population Total Clearance (Cl/F) of nemolizumab will be reported.

    Measured: From Baseline up to Week 16

  2. Population Pharmacokinetics (PopPK) Model of the Distribution of nemolizumab During the 16-week Treatment Period Point

    Point Estimate of Population Volume of Distribution (Vd/F) of nemolizumab will be reported.

    Measured: From Baseline up to Week 16

  3. Population Pharmacokinetics (PopPK) Model of the Absorption of nemolizumab During the 16-week Treatment Period Point

    Point Estimate of Absorption Rate Constant (Ka) of nemolizumab will be reported.

    Measured: From Baseline up to Week 16

  4. Pharmacokinetic (PK)/Pharmacodynamic (PD) Model of the Effect of nemolizumab Systemic Exposure on Pruritus during 16-week Treatment Period

    Point Estimate of population IC50 of nemolizumab, i.e. the drug concentration required to produce 50% of the maximal inhibition of Average Peak Pruritus, will be reported.

    Measured: From Baseline up to Week 16

Secondary outcomes (11)

  1. Individual Observed Ctrough Concentrations of nemolizumab

    Average of individual observed Ctrough concentrations of nemolizumab at week 16 will be reported.

    Measured: Week 16

  2. Individual Model - derived Ctrough Concentrations of nemolizumab

    Average of individual model-derived Ctrough concentrations of nemolizumab at week 16 will be reported.

    Measured: Week 16

  3. Individual Total Clearance (Cl/F) of nemolizumab

    Average of individual model-derived estimates of Cl/F will be reported.

    Measured: From Baseline up to Week 16

  4. Individual Volume of Distribution (Vd/F) of nemolizumab

    Average of individual model-derived estimates of Vd/F will be reported.

    Measured: From Baseline up to Week 16

  5. Individual Absorption Rate Constant (Ka) of nemolizumab

    Average of individual model-derived estimates of Ka will be reported.

    Measured: From Baseline up to Week 16

  6. Individual Maximum Serum Concentration (Cmax) of nemolizumab

    Average of individual model-derived estimates of Cmax will be reported.

    Measured: From Baseline up to Week 16

  7. Individual Time to Reach Maximum Serum Concentration (Tmax) of nemolizumab

    Average of individual model-derived estimates of Tmax will be reported.

    Measured: From Baseline up to Week 16

  8. Individual Area Under the Concentration-time Curve Within a Dosing Interval (AUCtau) of nemolizumab

    Average of individual model-derived estimates of AUCtau will be reported.

    Measured: From Baseline up to Week 16

  9. Terminal Half-life (t1/2) of nemolizumab

    Average of individual model-derived estimates of t1/2 will be reported.

    Measured: From Baseline up to Week 16

  10. Change From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS)

    PP NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Participant will report PP NRS via daily e-PRO diary.

    Measured: Up to Week 16

  11. Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs), AEs Leading to Study Intervention Withdrawal, AEs Leading to Study Discontinuation

    AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug during the study. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. AEs Leading to study treatment withdrawal and AEs Leading to study withdrawal will also be reported.

    Measured: From start of study up to follow-up period (Week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start20 Oct 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074977
Sponsor's protocol ID
SPR207913
Acronym
CPUO
Status last verified
Jul 2026
First submitted
24 Jun 2025
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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