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

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.