Home › Trials › NCT07074977

Nemolizumab for adults with chronic unexplained itching

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)

Phase 2 Interventional Galderma R&D · NCT07074977

This study will try nemolizumab versus placebo in adults with chronic unexplained itching to see how the drug behaves in the body and how it affects severe itch over a 16-week treatment period.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorGalderma R&D Industry-sponsored
Drugs / interventionsnemolizumab, nemolizmab
Locations24 sites (Birmingham, Alabama and 23 other locations)
Trial IDNCT07074977 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2 study enrolls adults with chronic pruritus of unknown origin lasting at least six months and high baseline itch scores. Participants are randomized 4:1 to receive weight-based dosing of nemolizumab or placebo, with dosing adjusted for those under 90 kg versus 90 kg or above. The timeline includes a 2–4 week screening period, a 16-week treatment period, and an 8-week follow-up (with overall participation up to about 28 weeks). The primary focus is defining the pharmacokinetic/pharmacodynamic relationship between nemolizumab exposure and itch response.

Who should consider this trial

Good fit: Adults aged 18 or older with chronic pruritus on largely normal-appearing skin for ≥6 months, pruritus affecting at least four body areas, a history of poor control with prior treatments, and a peak/weekly average PP-NRS score ≥7 are the intended candidates.

Not a fit: Patients whose itch has a clear identifiable cause, who have mild itch (PP-NRS <7), or whose symptoms are limited in extent or well controlled by existing treatments are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, nemolizumab could reduce severe unexplained itching and improve quality of life for adults with CPUO.

How similar studies have performed: Nemolizumab and other IL-31–targeting approaches have shown promising itch reduction in conditions like atopic dermatitis and prurigo nodularis, so this builds on prior positive data in related itchy skin diseases.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Participant must be 18 years of age or older.
  2. Participants with chronic pruritus on normal-appearing skin (except for dry skin or excoriations) for at least 6 months before the screening visit.
  3. Chronic pruritus considered of unknown origin (i.e., without a clear association to another condition or medication) as assessed by the investigator at baseline.
  4. 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.
  5. History of insufficient control of the chronic pruritus with prior treatment.
  6. Peak Pruritus Numeric Rating Scale (PP NRS) score greater than and equal to (\>=) 7 in the 24-hour period prior to the Screening visit.
  7. 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.
  8. 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.
  9. 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.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply :

Medical Conditions

1. 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.
2. Documented parasitic infection, including skin parasites such as scabies, within 12 weeks prior randomization.
3. 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.
4. 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).
5. Any medical or psychological condition or any clinically relevant laboratory abnormalities that put the participant at significant risk.
6. History of bullous pemphigoid or positive bullous pemphigoid autoantibodies at screening.
7. History of mastocytosis or serum total tryptase greater than (\>) 20 nanograms per milliliter (ng/ml) at screening.
8. Active tuberculosis (TB) or non-tuberculosis mycobacterial infection, or a history of incompletely treated TB.
9. 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.
10. Known or suspected immunodeficiency.
11. Lymphoproliferative disease or malignancy within the last 5 years.
12. 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.
13. Receipt of prohibited medications within the specified timeframe before the baseline visit
14. Previous participation in a clinical study with nemolizumab
15. 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.
16. Body weight \< 30 kg.
17. Prior treatment with commercially available nemolizmab
18. Hypersensitivity to the active substance (nemolizumab) or to any of the excipients of the study intervention.
19. Requiring rescue therapy for pruritus during the screening period.
20. Alcohol or substance abuse within 6 months of the screening visit.
21. Planned or anticipated major surgical procedure or other activity that would interfere with the participant's ability to comply with protocol-mandated assessments.
22. Pregnant or breastfeeding female, or female planning a pregnancy during the study.
23. 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.

Where this trial is running

Birmingham, Alabama and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Pruritus of Unknown Origin
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.