| Secondary | Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Percentage of participants with IGA "0" or "1" are reported at each visit. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| | | Title | Denominators | Categories |
|---|
| Week 2 | | | | Week 4 | |
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| Secondary | Percent Change From Baseline in EASI Score | The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | percent change | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in EASI Score | The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | score on scale | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to the given time point. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to the given time point. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to the given time point. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | percent change | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). A decrease in score indicated improvement. SCORAD-50 was defined as ≥50% reduction from baseline in SCORAD score. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | Percentage of change | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in Weekly Average of Daily PP NRS Score | Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percent Change From Baseline in Percent Body Surface Area (BSA) | BSA affected by AD was assessed for each section of the body using the rule of nines (the possible highest score for each region was: head and neck [9%], interior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). BSA was reported as a percentage of all major body sections combined. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | Percentage of change | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on QOL; over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL). A decrease in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | CDLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL) in children. A decrease in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (Higher score indicative of more severe symptoms). Total score was an average of the disease symptoms assessed. A decrease in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | The Hospital Anxiety and Depression Scale (HADS) is a screening tool designed to assess anxiety and depression. The scale consists of 14 items, divided into two subscales: Anxiety (HADS-A): 7 items; Depression (HADS-D): 7 items. The range of the total score is 0-42 (sum of HADS-A and HADS-D), with higher score indicating more severe overall psychological distress. The two subscales can be reported separately, each with a score range of 0-21, with higher score indicating more severe symptoms of anxiety or depression. A decrease in either the total score or a subscale score indicates improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in Skin Pain NRS (SP NRS) Score | SP NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants selected the number between 0 and 10 that fit best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain imaginable). A decrease in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in Weekly Average Sleep Quality NRS Score | Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicated worst possible sleep while 10 indicated best possible sleep. An increase in score indicated improvement. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of "No symptoms" at the specified timepoints. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of "No symptoms" or "Mild symptoms" at the specified timepoints. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better" | The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) "much better" to (7) "much worse", with (4) = "no change". Data are reported for the percentage of participants who rated their eczema symptoms as "Much better" at the specified timepoints. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better" | The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) "much better" to (7) "much worse", with (4) = "no change". Data are reported for the percentage of participants who rated their eczema symptoms as "Moderately better" at the specified timepoints. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs) | A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Data are reported for the number of participants with non-herpetic skin infection TEAEs. A summary of all serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Safety Set: All participants who were enrolled in the study and received at least 1 dose of dupilumab during the study. | Posted | | Count of Participants | | Participants | | Day 1 through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Secondary | Change From Baseline in Total Immunoglobulin (E) IgE | Serum samples were collected to measure concentrations of IgE. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | kU/L | | Weeks 4, 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| | |
| Secondary | Percent Change From Baseline in Total IgE | Serum samples were collected to measure concentrations of IgE. | Here 'n' = Number of evaluable participants at the specified timepoint. | Posted | | Mean | Standard Deviation | percent change | | Weeks 4, 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| | |
| Secondary | Trough Concentration of Functional Dupilumab in Serum | Adolescents and adults received 1 of 2 dose regimens based on age and body weight. The trough concentration of functional dupilumab in serum for the 2 dose regimens at the specified time points are presented. Participants treated and had at least one evaluable post-first-dose concentration measurement. | Pharmacokinetic (PK) Analysis Set: All participants who received any study drug and who had at least 1 non-missing PK result following the first dose of any study drug. Analysis was based on the treatment received. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed' = participants evaluable at specified timepoint. | Posted | | Mean | Standard Deviation | mg/L | | Week 12 and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |
| Primary | Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 24. | Here 'n' = number of evaluable participants at the specified timepoint. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Dupilumab | Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. |
| |