A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics and Safety of Nemolizumab (CD14152) in Adolescent Subjects (12-17 Years) With Moderate-to-Severe Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03921411

Enrollment

Registered

2019-04-19

Start date

2019-04-09

Completion date

2020-08-19

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Nemolizumab, Atopic dermatitis

Brief summary

The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.

Interventions

BIOLOGICALNemolizumab

Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria * Male or female participants ≥ 12 to \< 17 years of age * Chronic AD that has been documented for at least 2 years * Eczema Area and Severity Index (EASI) score ≥ 16 * Investigator's Global Assessment (IGA) score ≥ 3 * AD involvement ≥ 10% of Body Surface Area (BSA) * Documented recent history of inadequate response to topical medications * Women of childbearing potential must agree to be strictly abstinent or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. Key

Exclusion criteria

* Body weight \< 30 kilogram (kg) * Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week * History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example., monoclonal antibody) * Any medical or psychological condition, or any clinically relevant laboratory abnormalities that may have put the subject at significant risk according to the investigator's judgment

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value at Week 4	At week 4	PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. PEF \<80% of predictive value is considered as abnormal.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16	At week 16	Ctrough is the concentration prior to study drug administration.
Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)	Pre-dose through 4 weeks post-dose	Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule.
Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)	Pre-dose through 8 weeks post-dose	Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule.
Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)	Pre-dose through 12 week post-dose	Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule.
Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)	Pre-dose through 16 weeks post-dose	Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule.
Apparent Terminal Half-life (t1/2)	Baseline to week 24	Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the serum to decrease by 50%.
Number of Participants With Treatment-Related Positive Anti-Drug Antibodies (ADA) in Serum at Week 4	At week 4	Antidrug antibodies were determined using a validated enzyme-linked immunosorbent assay (ELISA) assay. Number of participants with positive ADA in Serum were reported.
Number of Participants With Neutralizing Antibodies	Baseline up to Week 24	The number of participants with neutralizing antibodies response at time of baseline up to week 24 has been presented. Neutralizing antibodies response assay result have been only presented for participants with positive anti-drug antibody assay.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)	Baseline through week 24	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAE was defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. An AESI is a noteworthy event for study drug that should be monitored closely and reported immediately. The following AEs will be considered AESIs: Anaphylactic reactions, Acute allergic reactions requiring treatment, Severe injection site reaction, Newly-diagnosed asthma or worsening of asthma, Peripheral edema: limbs, bilateral and Facial edema.
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 1-2	At week 1-2	The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 4	At week 4	The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 8	At week 8	The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 12	At week 12	The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) Findings	Baseline up to Week 24	A complete PE included assessments of the head, ears, eyes, nose, throat, neck (including thyroid), skin/integumentary system, cardiovascular system, respiratory system, gastrointestinal system, musculoskeletal system, lymph nodes, and nervous system. Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Abnormalities in Laboratory Values	Baseline up to Week 24	Laboratory investigation included hematology, biochemistry, and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant abnormalities in laboratory parameters were reported.
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings at Week 16	At week 16	The ECG recordings were obtained after 10 minutes of rest in a semi-supine position. Number of participants with clinically significant change from baseline in ECG findings were reported. Clinically significance was decided by investigator.
Number of Participants With Clinically Significant Abnormalities in Vital Signs	Baseline up to Week 24	Vital signs included pulse rate, systolic and diastolic blood pressure (after the participant had been sitting for at least 5 minutes), and body temperature. Clinically significance was decided by investigator..
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% of Predicted Value at Week 1-2	At week 1-2	PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. PEF \<80% of predictive value is considered as abnormal.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4	At week 4	Ctrough is the concentration prior to study drug administration.
Nemolizumab Serum Concentrations at Week 1-2	At week 1-2	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 4	At week 4	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 8	At week 8	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 12	At week 12	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 16	At week 16	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 24	At week 24	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab	Baseline to week 24	CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time \[AUC (0-inf)\].
Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab	Baseline to week 24	Vd/F was calculated as dose divided by lambda\_z \*AUC(0-inf).
Population Lag Time (Tlag)	Baseline to week 24	Lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. The population Tlag value was estimated for the overall population and was reported in this endpoint.
First Order Constant of Absorption (ka)	Baseline to week 24	PK of Nemolizumab was evaluated in participants using Ka using PK samples collected on Weeks 1-2, 4, 8, 12, 16 and 24. Ka was evaluated by population PK (popPK) methods and mean and standard from the model has been tabulated.
Maximum Observed Serum Concentration (Cmax) of Nemolizumab	Baseline to week 12	Cmax was obtained from serum concentration time curve.
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab	Baseline to week 12	Time to reach maximum observed serum concentration (Tmax) for Nemolizumab was derived from serum concentrations versus time data.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8	At week 8	Ctrough is the concentration prior to study drug administration.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12	At week 12	Ctrough is the concentration prior to study drug administration.

Secondary

Measure	Time frame	Description
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)	Pre-dose through 8 weeks post-dose	Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule.
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)	Pre-dose through 12 week post-dose	Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)	Pre-dose through 16 weeks post-dose	Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule.
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16	Baseline, Week 16	EASI assesses severity and extent of atopic dermatitis (AD) signs through a composite score of erythema, induration/population, excoriation, and lichenification. Each characteristic was assessed for severity on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs. The total EASI score range from 0 to 72 with higher scores representing greater severity of AD.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16	Baseline, Week 16	EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. Each characteristic was assessed for severity on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs. The EASI score can range from 0 to 72 with higher scores representing greater severity of AD.
Number of Participants Who Achieved Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) From Baseline to Week 16	Baseline to Week 16	IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. Ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), where higher score indicated higher severity. IGA success is defined as participants with 0 (clear) or 1 (almost clear) and at least 2 -grade improvement from baseline. Number of Participants who achieved Investigator's Global Assessment (IGA) Success from baseline to week 16 were reported.
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24	Baseline, Week 1-2, 4, 8, 12, 14, 16 and 24	BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16	Baseline, Week 16	Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.
Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16	Baseline, Week 16	Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.
Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16	Baseline, Week 16	Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.
Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16	Baseline, Week 16	Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16	Baseline, Week 16	The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16	Baseline, Week 16	The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 16	Baseline, Week 16	Scoring Atopic Dermatitis (SCORAD) is a validated measure commonly used to assess the severity and the extent of AD signs and symptoms. SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of six types of basic lesions (erythema/darkening, edema/papule, oozing/crusting, excoriation, lichenification/prurigo and dryness) and symptoms (itching and loss of sleep) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24	Baseline through Week 24	Number of topical AD medication-free days through Week 16 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days.
Dermatology Life Quality Index (DLQI) For Participants > 16 Years of Age at Baseline and Week 16	Baseline, Week 16	The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participants were rate each question ranging from 0 (not at all) to 3 (very much) and overall score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
Children's Dermatology Life Quality Index (cDLQI) For Participants 12-16 Years of Age at Baseline and Week 16	Baseline, Week 16	The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participants were rate each question ranging from 0 (not at all) to 3 (very much) and overall score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
Non-Compartmental Analysis: Area Under the Serum Concentration-time Curve From Time Zero to 4 Weeks Post-dose AUC(0-4w)	Pre-dose through 4 weeks post-dose	Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule.

Countries

United States

Participant flow

Recruitment details

A total of 31 participants were screened, of which 20 were enrolled and 18 participants were treated with study drug.

Participants by arm

Arm	Count
Nemolizumab Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.	20
Total	20

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Enrolled, but never treated	2
Overall Study	Protocol Deviation	2
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Nemolizumab
Age, Continuous	14.8 Years STANDARD_DEVIATION 1.59
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race/Ethnicity, Customized Asian	2 Participants
Race/Ethnicity, Customized Black or African American	10 Participants
Race/Ethnicity, Customized Other: Hispanic	1 Participants
Race/Ethnicity, Customized White	7 Participants
Sex: Female, Male Female	12 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 18
other Total, other adverse events	6 / 18
serious Total, serious adverse events	2 / 18

Outcome results

Primary

Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab

CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time \[AUC (0-inf)\].

Time frame: Baseline to week 24

Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value.

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab	0.325 liter/day (L/day)	Standard Deviation 0.153

Primary

Apparent Terminal Half-life (t1/2)

Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the serum to decrease by 50%.

Time frame: Baseline to week 24

Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value.

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	Apparent Terminal Half-life (t1/2)	16.666 day	Standard Deviation 4.115

Primary

Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab

Vd/F was calculated as dose divided by lambda\_z \*AUC(0-inf).

Time frame: Baseline to week 24

Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab	7.15 liter	Standard Deviation 2.24

Primary

Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)

Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule.

Time frame: Pre-dose through 12 week post-dose

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)	411707.857 ng*day/mL	Standard Deviation 142851.408

Primary

Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)

Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule.

Time frame: Pre-dose through 16 weeks post-dose

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)	549489.167 ng*day/mL	Standard Deviation 184483.765

Primary

Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)

Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule.

Time frame: Pre-dose through 8 weeks post-dose

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)	284397.143 ng*day/mL	Standard Deviation 97105.285

Primary

Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)

Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule.

Time frame: Pre-dose through 4 weeks post-dose

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)	144046.235 nanogramday per milliliter (ngday/mL)	Standard Deviation 50800.805

Primary

First Order Constant of Absorption (ka)

PK of Nemolizumab was evaluated in participants using Ka using PK samples collected on Weeks 1-2, 4, 8, 12, 16 and 24. Ka was evaluated by population PK (popPK) methods and mean and standard from the model has been tabulated.

Time frame: Baseline to week 24

Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	First Order Constant of Absorption (ka)	0.402 1/day	Standard Deviation 0.145

Primary

Maximum Observed Serum Concentration (Cmax) of Nemolizumab

Cmax was obtained from serum concentration time curve.

Time frame: Baseline to week 12

Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value.

Arm	Measure	Value (MEAN)	Dispersion
Nemolizumab	Maximum Observed Serum Concentration (Cmax) of Nemolizumab	5975.5 ng/mL	Standard Deviation 2175.2

Primary