| Primary | Nemolizumab Serum Concentrations | Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA). | Analysis was performed on Pharmacokinetic (PK) Set. The PK Set consisted of all participants who received at least 1 dose of study drug and have at least one measurable post-baseline concentration. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | nanograms per milliliters (ng/mL) | | At Weeks 4, 8, 12, 16, 32 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
| | | Title | Denominators | Categories |
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| Week 4 | - ParticipantsOG00036
- ParticipantsOG00137
- ParticipantsOG00234
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| Primary | Apparent Total Body Clearance (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)]. Individual nemolizumab. | Analysis was performed on the PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and had at least one measurable post-baseline concentration. | Posted | | Mean | Standard Deviation | liter per day (L/day) | | Pre-dose at Weeks 4, 8, 12, 16, 32 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Primary | Apparent Volume of Distribution (Vd/F) of Nemolizumab | Vd/F was calculated as dose divided by lambda_z *AUC(0-inf). | Analysis was performed on the PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and had at least one measurable post-baseline concentration. | Posted | | Mean | Standard Deviation | liter | | Pre-dose at Weeks 4, 8, 12, 16, 32 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Primary | Absorption Rate Constant (Ka) of Nemolizumab | | Analysis was performed on the PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and had at least one measurable post-baseline concentration. | Posted | | Mean | Standard Deviation | per day | | Pre-dose at Weeks 4, 8, 12, 16, 32 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Primary | Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab | | Analysis was performed on the PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and had at least one measurable post-baseline concentration. | Posted | | Mean | Standard Deviation | micrograms per milliliter (ug/mL) | | Pre-dose at Weeks 4, 8, 12, and 16 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Primary | Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab | | Analysis was performed on the PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and had at least one measurable post-baseline concentration. | Posted | | Mean | Standard Deviation | days*nanograms per milliliters | | Pre-dose at Weeks 4, 8, 12, 16, 32 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Primary | Apparent Terminal Half-life (t1/2) of Nemolizumab | | Analysis was performed on the PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and had at least one measurable post-baseline concentration. | Posted | | Mean | Standard Deviation | day | | Pre-dose at Weeks 4, 8, 12, 16, 32 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Adverse Events Leading to Discontinuation and Serious Adverse Events (SAEs) | 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. | Analysis was performed on the safety set. The safety set consisted of all enrolled participants who received at least 1 dose of the study drug. | Posted | | Count of Participants | | Participants | | Baseline through Week 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years |
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| Secondary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52 | EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis. | Analysis was performed on the intent-to-treat (ITT) set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 |
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| Secondary | Absolute Change From Baseline in EASI Score | EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years |
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| Secondary | Number of Participants Achieving 50 Percent (%), 75% or 90% Response From Baseline in EASI (EASI-50, EASI-75 and EASI-90) | EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved greater than or equal to (>=) 50%, >=75% and >=90% overall improvement in EASI score respectively from baseline to Week 52. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Count of Participants | | Participants | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Secondary | Number of Participants With Investigator's Global Assessment (IGA) Success Rate | IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Here, higher score indicates severe outcome. Success was defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >=2-points improvement from baseline. Number of participants with IGA success rate was reported for this outcome measure. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Count of Participants | | Participants | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 |
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| Secondary | Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) | 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. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | percentage of BSA involvement | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years |
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| Secondary | Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score | Pruritus 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 were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | |
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| Secondary | Percent Change From Baseline in Weekly Average of PP NRS Score | Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Secondary | Percentage of Participants With an Improvement of >= 4 From Baseline in Weekly Average of PP NRS | Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Number | | percentage of participants | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | |
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| Secondary | Absolute Change From Baseline in Weekly Average of Average Pruritus NRS Score | Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | |
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| Secondary | Percent Change From Baseline in Weekly Average of Average Pruritus NRS Score | Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Secondary | Absolute Change From Baseline in Weekly Average of Sleep Disturbance NRS Score | 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 indicated worse outcome. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years |
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| Secondary | Percent Change From Baseline in Weekly Average of Sleep Disturbance NRS Score | 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 indicated worse outcome. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years |
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| Secondary | Percentage of Participants Receiving Any Rescue Therapy by Rescue Treatment | Percentage of participants receiving any rescue therapy by rescue treatment was reported. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. | Posted | | Number | | percentage of participants | | From Baseline up to Week 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Secondary | Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease), a higher score indicated severe disease. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Secondary | Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age | The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer quality of life (QoL). | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 16 and Week 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years |
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| Secondary | Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) Score For Participants Less Than (<) 4 Years of Age | The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer QoL. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data at each specified timepoint. Data is reported for arm Cohort 2: Participants Aged 2-6 Years. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 16 and Week 52 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Secondary | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | The POEM is a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease). A high score indicated poor QOL. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 16 and Week 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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| Secondary | Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in PP NRS | The relationship between nemolizumab serum concentrations and changes in PP-NRS score was established using population point estimate of IC50, where IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in PP NRS. | Analysis was performed on PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and have at least one measurable post-baseline concentration. | Posted | | Number | | ug/mL | | Baseline up to Week 52 | | | | ID | Title | Description |
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| OG000 | Nemolizumab: All Participants | Participants received SC injections of nemolizumab Q4W for a total duration of 52 weeks. Dose levels and loading doses were assigned according to age-based cohorts as follows: Cohort 1 (7-11 years)- Participants received 10, 20, or 30 mg nemolizumab, Q4W for 52 weeks with a weight-based loading dose of 20, 40, or 60 mg nemolizumab on Day 1; Cohort 1.1 (7-11 years)-Participants received 5, 10, or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20, or 30 mg nemolizumab on Day 1; Cohort 2 (2-6 years)- Participants received 5, 10, or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20, or 30 mg nemolizumab on Day 1. |
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| Secondary | PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in EASI Score | The relationship between nemolizumab serum concentrations and changes in EASI score was established using population point estimate of IC50. Where, IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in EASI score. | Analysis was performed on PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and have at least one measurable post-baseline concentration. | Posted | | Number | | ug/mL | | Baseline up to Week 52 | | | | ID | Title | Description |
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| OG000 | Nemolizumab: All Participants | Participants received SC injections of nemolizumab Q4W for a total duration of 52 weeks. Dose levels and loading doses were assigned according to age-based cohorts as follows: Cohort 1 (7-11 years)- Participants received 10, 20, or 30 mg nemolizumab, Q4W for 52 weeks with a weight-based loading dose of 20, 40, or 60 mg nemolizumab on Day 1; Cohort 1.1 (7-11 years)-Participants received 5, 10, or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20, or 30 mg nemolizumab on Day 1; Cohort 2 (2-6 years)- Participants received 5, 10, or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20, or 30 mg nemolizumab on Day 1. |
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| Secondary | PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in IGA Score | The relationship between nemolizumab serum concentrations and changes in IGA score was established using the population point estimate of the slope parameter. | Analysis was performed on PK Set. The PK Set consisted of all participants who received at least 1 dose of study drug and have at least one measurable post-baseline concentration. | Posted | | Number | | liter per micrograms (L/ug) | | Baseline up to Week 52 | | | | ID | Title | Description |
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| OG000 | Nemolizumab: All Participants | Participants received SC injections of nemolizumab Q4W for a total duration of 52 weeks. Dose levels and loading doses were assigned according to age-based cohorts as follows: Cohort 1 (7-11 years)- Participants received 10, 20, or 30 mg nemolizumab, Q4W for 52 weeks with a weight-based loading dose of 20, 40, or 60 mg nemolizumab on Day 1; Cohort 1.1 (7-11 years)-Participants received 5, 10, or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20, or 30 mg nemolizumab on Day 1; Cohort 2 (2-6 years)- Participants received 5, 10, or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20, or 30 mg nemolizumab on Day 1. |
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| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) for Nemolizumab | ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result. | Analysis was performed on the ITT set. The ITT set consisted of all enrolled participants. | Posted | | Count of Participants | | Participants | | Baseline, Week 16 and Week 52 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Participants Aged 7-11 Year | Participants aged 7-11 years received SC injection of 10, 20 or 30 mg nemolizumab, Q4W for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight. | | OG001 | Cohort 1.1: Participants Aged 7-11 Years | Participants aged 7-11 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. | | OG002 | Cohort 2: Participants Aged 2-6 Years | Participants aged 2-6 years received SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight. |
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