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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
Participants will receive matching placebo as SC injection.
Galderma Investigational Site (site# 8893)
Birmingham, Alabama, United States
RECRUITINGPopulation 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline up to Week 16
Individual Observed Ctrough Concentrations of nemolizumab
Average of individual observed Ctrough concentrations of nemolizumab at week 16 will be reported.
Time frame: Week 16
Individual Model - derived Ctrough Concentrations of nemolizumab
Average of individual model-derived Ctrough concentrations of nemolizumab at week 16 will be reported.
Time frame: Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Galderma Investigational Site (site# 8130)
Los Angeles, California, United States
Galderma Investigational Site (site# 8021)
San Diego, California, United States
NOT_YET_RECRUITINGGalderma Investigational Site (site# 7075)
San Francisco, California, United States
NOT_YET_RECRUITINGGalderma Investigational Site (site# 7054)
Tampa, Florida, United States
NOT_YET_RECRUITINGGalderma Investigational Site (site# 8142)
Indianapolis, Indiana, United States
NOT_YET_RECRUITINGGalderma Investigational Site (site# 8743)
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGGalderma Investigational Site (site# 8521)
Saint Joseph, Missouri, United States
NOT_YET_RECRUITINGGalderma Investigational Site (site# 8108)
Las Vegas, Nevada, United States
NOT_YET_RECRUITINGGalderma Investigational Site (site# 7110)
New City, New York, United States
NOT_YET_RECRUITING...and 4 more locations
Individual Total Clearance (Cl/F) of nemolizumab
Average of individual model-derived estimates of Cl/F will be reported.
Time frame: From Baseline up to Week 16
Individual Volume of Distribution (Vd/F) of nemolizumab
Average of individual model-derived estimates of Vd/F will be reported.
Time frame: From Baseline up to Week 16
Individual Absorption Rate Constant (Ka) of nemolizumab
Average of individual model-derived estimates of Ka will be reported.
Time frame: From Baseline up to Week 16
Individual Maximum Serum Concentration (Cmax) of nemolizumab
Average of individual model-derived estimates of Cmax will be reported.
Time frame: From Baseline up to Week 16
Individual Time to Reach Maximum Serum Concentration (Tmax) of nemolizumab
Average of individual model-derived estimates of Tmax will be reported.
Time frame: From Baseline up to Week 16
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.
Time frame: From Baseline up to Week 16
Terminal Half-life (t1/2) of nemolizumab
Average of individual model-derived estimates of t1/2 will be reported.
Time frame: From Baseline up to Week 16
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.
Time frame: Up to Week 16
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.
Time frame: From start of study up to follow-up period (Week 24)