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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nemolizumab
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Nemolizumab, Atopic dermatitis

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nemolizumab

Arm Description

Nemolizumab

Outcomes

Primary Outcome Measures

Nemolizumab Serum Concentrations at Week 1-2
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 4
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 8
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 12
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 16
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations 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
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
Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).
Population Lag Time (Tlag)
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)
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
Cmax was obtained from serum concentration time curve.
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
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 4
Ctrough is the concentration prior to study drug administration.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8
Ctrough is the concentration prior to study drug administration.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12
Ctrough is the concentration prior to study drug administration.
Trough Serum Concentration (Ctrough) of Nemolizumab 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)
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)
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)
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)
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)
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
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
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)
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
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
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
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
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
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
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
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
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
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.
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value 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.

Secondary Outcome Measures

Non-Compartmental Analysis: Area Under the Serum Concentration-time Curve From Time Zero to 4 Weeks Post-dose AUC(0-4w)
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.
Non-Compartmental Analysis: 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.
Non-Compartmental Analysis: 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
Non-Compartmental Analysis: 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.
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at 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
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
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
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
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
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
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
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
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
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
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
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
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
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).

Full Information

First Posted
March 29, 2019
Last Updated
April 10, 2023
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT03921411
Brief Title
A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
August 19, 2020 (Actual)
Study Completion Date
August 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Nemolizumab, Atopic dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nemolizumab
Arm Type
Experimental
Arm Description
Nemolizumab
Intervention Type
Biological
Intervention Name(s)
Nemolizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nemolizumab Serum Concentrations at Week 1-2
Description
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Time Frame
At week 1-2
Title
Nemolizumab Serum Concentrations at Week 4
Description
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Time Frame
At week 4
Title
Nemolizumab Serum Concentrations at Week 8
Description
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Time Frame
At week 8
Title
Nemolizumab Serum Concentrations at Week 12
Description
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Time Frame
At week 12
Title
Nemolizumab Serum Concentrations at Week 16
Description
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Time Frame
At week 16
Title
Nemolizumab Serum Concentrations at Week 24
Description
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Time Frame
At week 24
Title
Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab
Description
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
Title
Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab
Description
Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).
Time Frame
Baseline to week 24
Title
Population Lag Time (Tlag)
Description
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.
Time Frame
Baseline to week 24
Title
First Order Constant of Absorption (ka)
Description
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
Title
Maximum Observed Serum Concentration (Cmax) of Nemolizumab
Description
Cmax was obtained from serum concentration time curve.
Time Frame
Baseline to week 12
Title
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
Description
Time to reach maximum observed serum concentration (Tmax) for Nemolizumab was derived from serum concentrations versus time data.
Time Frame
Baseline to week 12
Title
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4
Description
Ctrough is the concentration prior to study drug administration.
Time Frame
At week 4
Title
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8
Description
Ctrough is the concentration prior to study drug administration.
Time Frame
At week 8
Title
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12
Description
Ctrough is the concentration prior to study drug administration.
Time Frame
At week 12
Title
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16
Description
Ctrough is the concentration prior to study drug administration.
Time Frame
At week 16
Title
Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)
Description
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
Title
Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
Description
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
Title
Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
Description
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
Title
Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
Description
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
Title
Apparent Terminal Half-life (t1/2)
Description
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
Title
Number of Participants With Treatment-Related Positive Anti-Drug Antibodies (ADA) in Serum at Week 4
Description
Antidrug antibodies were determined using a validated enzyme-linked immunosorbent assay (ELISA) assay. Number of participants with positive ADA in Serum were reported.
Time Frame
At week 4
Title
Number of Participants With Neutralizing Antibodies
Description
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.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline through week 24
Title
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 1-2
Description
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.
Time Frame
At week 1-2
Title
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 4
Description
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.
Time Frame
At week 4
Title
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 8
Description
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.
Time Frame
At week 8
Title
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 12
Description
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.
Time Frame
At week 12
Title
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) Findings
Description
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.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Clinically Significant Abnormalities in Laboratory Values
Description
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.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings at Week 16
Description
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.
Time Frame
At week 16
Title
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Description
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..
Time Frame
Baseline up to Week 24
Title
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% of Predicted Value at Week 1-2
Description
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.
Time Frame
At week 1-2
Title
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value at Week 4
Description
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.
Time Frame
At week 4
Secondary Outcome Measure Information:
Title
Non-Compartmental Analysis: Area Under the Serum Concentration-time Curve From Time Zero to 4 Weeks Post-dose AUC(0-4w)
Description
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
Title
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
Description
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
Title
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
Description
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
Title
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
Description
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
Title
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
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
Description
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.
Time Frame
Baseline to Week 16
Title
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
Description
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.
Time Frame
Baseline, Week 1-2, 4, 8, 12, 14, 16 and 24
Title
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 16
Description
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).
Time Frame
Baseline, Week 16
Title
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Description
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.
Time Frame
Baseline through Week 24
Title
Dermatology Life Quality Index (DLQI) For Participants > 16 Years of Age at Baseline and Week 16
Description
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).
Time Frame
Baseline, Week 16
Title
Children's Dermatology Life Quality Index (cDLQI) For Participants 12-16 Years of Age at Baseline and Week 16
Description
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).
Time Frame
Baseline, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Galderma Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Galderma Investigational Site
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Galderma Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Galderma Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Galderma Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Galderma Investigational Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30128
Country
United States
Facility Name
Galderma Investigational Site
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Galderma Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-5806
Country
United States
Facility Name
Galderma Investigational Site
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Galderma Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35088348
Citation
Sidbury R, Alpizar S, Laquer V, Dhawan S, Abramovits W, Loprete L, Krishnaswamy JK, Ahmad F, Jabbar-Lopez Z, Piketty C. Pharmacokinetics, Safety, Efficacy, and Biomarker Profiles During Nemolizumab Treatment of Atopic Dermatitis in Adolescents. Dermatol Ther (Heidelb). 2022 Mar;12(3):631-642. doi: 10.1007/s13555-021-00678-7. Epub 2022 Jan 28.
Results Reference
derived

Learn more about this trial

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

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