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

NCT07074977 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SPR207913
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 24

Brief 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.

Conditions

Chronic Pruritus of Unknown Origin

Outcome Measures

Primary Outcomes (4)

• 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.

  From Baseline up to Week 16

• 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.

  From Baseline up to Week 16

• 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.

  From Baseline up to Week 16

• 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.

  From Baseline up to Week 16

Secondary Outcomes (11)

• Individual Observed Ctrough Concentrations of nemolizumab

  Week 16

• Individual Model - derived Ctrough Concentrations of nemolizumab

  Week 16

• Individual Total Clearance (Cl/F) of nemolizumab

  From Baseline up to Week 16

• Individual Volume of Distribution (Vd/F) of nemolizumab

  From Baseline up to Week 16

• Individual Absorption Rate Constant (Ka) of nemolizumab

  From Baseline up to Week 16

Study Arms (2)

nemolizumab

EXPERIMENTAL

Participants 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.

Drug: nemolizumab

Placebo

PLACEBO COMPARATOR

Participants 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.

Drug: Placebo

Interventions

nemolizumab DRUG

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

Also known as: CD14152

nemolizumab

Placebo DRUG

Participants will receive matching placebo as SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (24)

Galderma Investigational Site (site# 8893)

Birmingham, Alabama, 35244, United States

RECRUITING

Galderma Investigational Site (#8768)

Tucson, Arizona, 85718, United States

NOT YET RECRUITING

Galderma Investigational Site (site# 8636)

Fountain Valley, California, 92708, United States

RECRUITING

Galderma Investigational Site (site# 8130)

Los Angeles, California, 90045, United States

RECRUITING

Galderma Investigational Site (#9975)

Sacramento, California, 95815, United States

RECRUITING

Galderma Investigational Site (site# 8021)

San Diego, California, 92123, United States

NOT YET RECRUITING

Galderma Investigational Site (site# 7075)

San Francisco, California, 94115, United States

RECRUITING

Galderma Investigational Site (site# 8608)

Santa Monica, California, 90404, United States

NOT YET RECRUITING

Galderma Investigational Site (#8295)

Miami, Florida, 33136, United States

NOT YET RECRUITING

Galderma Investigational Site (site# 7054)

Tampa, Florida, 33609, United States

RECRUITING

Galderma Investigational Site (site# 8142)

Indianapolis, Indiana, 46250, United States

NOT YET RECRUITING

Galderma Investigational Site (#7129)

Bowling Green, Kentucky, 42104, United States

NOT YET RECRUITING

Galderma Investigational Site (site# 8743)

Ann Arbor, Michigan, 48109, United States

RECRUITING

Galderma Investigational Site (site# 8521)

Saint Joseph, Missouri, 64506, United States

NOT YET RECRUITING

Galderma Investigational Site (site# 8108)

Las Vegas, Nevada, 89145, United States

RECRUITING

Galderma Investigational Site (site# 7110)

New City, New York, 10956, United States

RECRUITING

Galderma Investigational Site (#7130)

The Bronx, New York, 10455, United States

NOT YET RECRUITING

Galderma Investigational Site (site# 7111)

Fargo, North Dakota, 58103, United States

RECRUITING

Galderma Investigational Site (#8212)

Portland, Oregon, 97210, United States

NOT YET RECRUITING

Galderma Investigational Site (#8255)

Philadelphia, Pennsylvania, 19103, United States

RECRUITING

Galderma Investigational Site (site# 8003)

Webster, Texas, 77598, United States

RECRUITING

Galderma Investigational Site (site# 8862)

Fairfax, Virginia, 22031, United States

RECRUITING

Galderma Investigational Site (site# 8725)

Morgantown, West Virginia, 26505, United States

RECRUITING

Galderma Investigational Site (site# 8045)

Québec, Quebec, G1V 4X7, Canada

NOT YET RECRUITING

MeSH Terms

Interventions

nemolizumab

Central Study Contacts

Galderma Research and Development

CONTACT

817-961-5000; clinical.studies@galderma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 20, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (23)