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.
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.
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).
Parallel
nemolizumab
DrugParticipants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
Placebo
DrugParticipants will receive matching placebo as SC injection.
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.
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.
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.
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.
Individual Observed Ctrough Concentrations of nemolizumab
Average of individual observed Ctrough concentrations of nemolizumab at week 16 will be reported.
Individual Model - derived Ctrough Concentrations of nemolizumab
Average of individual model-derived Ctrough concentrations of nemolizumab at week 16 will be reported.
Individual Total Clearance (Cl/F) of nemolizumab
Average of individual model-derived estimates of Cl/F will be reported.
Individual Volume of Distribution (Vd/F) of nemolizumab
Average of individual model-derived estimates of Vd/F will be reported.
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