Atopic Dermatitis
Conditions
Keywords
Eczema
Brief summary
The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age). The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).
Interventions
DRUGDupilumab
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female patients ≥6 to \<18 years of age with a diagnosis of 1. Atopic Dermatitis whose disease cannot be adequately controlled with topical medications 2. Minimum disease severity, as defined by Investigator's Global Assessment (IGA) 1. IGA = 3 or 4 in adolescents ≥12 to \<18 year of age 2. IGA = 4 in children ≥6 to \<12 years of age Key
Exclusion criteria
1. Recent treatment (within specific time windows before the baseline visit) with systemic immunosuppressive agents for eg. Systemic corticosteroids, live (attenuated) vaccines and other investigational drugs including biologics 2. History of any of the following infections: 1. Any systemic infection requiring treatment within 4 weeks before the baseline visit 2. Superficial skin infections within 1 week before the baseline visit 3. Known history of HIV infection 4. History of seropositivity to hepatitis B or C screening tests 5. History of clinical endoparasitosis (ie, helminthic infection) within 12 months before the baseline visit, or high risk of helminthic infection, unless subsequent medical assessments (e.g. stool exam, blood tests, etc.) have ruled out the possibility of parasite infection/infestation 3. History of malignancy within 5 years before the baseline visit 4. Persistent (confirmed by repeated tests ≥2 weeks apart) elevated transaminases (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) more than 3 times the upper limit of normal (ULN) during the screening period 5. Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study 6. Presence of skin comorbidities that may interfere with study assessments 7. Females patients who are pregnant or breastfeeding 8. Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration | Day 2, 4, 8, 15, 22, 29, 36, 43, and 50 | Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug. |
| PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration | Day 2, 4, 8, 15, 22, 29, 36, 43, and 50 | Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug. |
| PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Pre-dose on Day 71 and Day 85 | Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Investigator Global Assessment (IGA) Score of 0 or 1 (Clear or Almost Clear) at Week 12 | Week 12 | IGA is an assessment scale used to determine severity of 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 is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF. Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used. |
| Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | Baseline to Week 12 (one week after last dose) | 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 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF). |
| Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12 | Baseline to Week 12 | Body surface area 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 \[1%\]). It was reported as a percentage of all major body sections combined. Analysis was performed on SAF. |
| Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12 | Baseline to Week 12 (one week after last dose) | SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993). 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 \[severe disease\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF. |
| Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12 | Baseline to Week 12 (one week after last dose) | Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF. |
Countries
Canada, Czechia, Germany, Hungary, Poland, United Kingdom
Participant flow
Recruitment details
The study was conducted at 25 sites in 6 countries. A total of 88 participants were screened, and of those, 78 participants were randomized with 77 being treated. Ten participants were screen failures as 5 were due to exclusion criteria met & inclusion criteria not met, 4 participants withdrew consent and 1 participant was lost to follow-up.
Pre-assignment details
A total of 40 adolescents (aged ≥12 to \<18 years) and 38 children (aged ≥6 to \<12 years) were enrolled and randomized to 2 sequential ascending dose cohorts: Cohort 1 (2 mg/kg) and Cohort 2 (4 mg/kg).
Participants by arm
| Arm | Count |
|---|---|
| Dupilumab 2mg/kg: Adolescents Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years. | 20 |
| Dupilumab 2mg/kg: Children Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years. | 18 |
| Dupilumab 4mg/kg: Adolescents Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years. | 20 |
| Dupilumab 4mg/kg: Children Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years. | 19 |
| Total | 77 |
Baseline characteristics
| Characteristic | Dupilumab 2mg/kg: Children | Dupilumab 4mg/kg: Adolescents | Dupilumab 4mg/kg: Children | Dupilumab 2mg/kg: Adolescents | Total |
|---|---|---|---|---|---|
| Age, Continuous | 8.2 years STANDARD_DEVIATION 1.62 | 14.3 years STANDARD_DEVIATION 1.66 | 8.2 years STANDARD_DEVIATION 1.99 | 14.7 years STANDARD_DEVIATION 2.01 | 11.5 years STANDARD_DEVIATION 3.64 |
| Body Surface Area (BSA) Involvement with Atopic Dermatitis (AD) | 59 Percentage of body surface area STANDARD_DEVIATION 22.49 | 45.9 Percentage of body surface area STANDARD_DEVIATION 25.34 | 62.3 Percentage of body surface area STANDARD_DEVIATION 30.34 | 52.2 Percentage of body surface area STANDARD_DEVIATION 24.78 | 54.6 Percentage of body surface area STANDARD_DEVIATION 26.19 |
| Eczema Area and Severity Index (EASI) score | 32.9 Score on a scale STANDARD_DEVIATION 15.53 | 28.6 Score on a scale STANDARD_DEVIATION 14.7 | 38.8 Score on a scale STANDARD_DEVIATION 18.64 | 34.8 Score on a scale STANDARD_DEVIATION 17 | 33.7 Score on a scale STANDARD_DEVIATION 16.62 |
| Ethnicity Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity Not Hispanic or Latino | 18 Participants | 20 Participants | 18 Participants | 20 Participants | 76 Participants |
| Number of Subjects with Investigator Global Assessment (IGA) score of 3 or 4 IGA score of 3 | 1 Participants | 11 Participants | 0 Participants | 8 Participants | 20 Participants |
| Number of Subjects with Investigator Global Assessment (IGA) score of 3 or 4 IGA score of 4 | 17 Participants | 9 Participants | 19 Participants | 12 Participants | 57 Participants |
| Pruritus Numerical Rating Scale (NRS) | 6.4 Score on a scale STANDARD_DEVIATION 2.23 | 6.9 Score on a scale STANDARD_DEVIATION 2.21 | 6.7 Score on a scale STANDARD_DEVIATION 2.35 | 6.1 Score on a scale STANDARD_DEVIATION 2.47 | 6.5 Score on a scale STANDARD_DEVIATION 2.29 |
| Race Asian | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race Other | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race White | 17 Participants | 15 Participants | 18 Participants | 17 Participants | 67 Participants |
| SCORing Atopic Dermatitis (SCORAD) Score | 66.4 Score on a scale STANDARD_DEVIATION 13.06 | 63 Score on a scale STANDARD_DEVIATION 14.43 | 72.7 Score on a scale STANDARD_DEVIATION 12.96 | 68 Score on a scale STANDARD_DEVIATION 13.19 | 67.5 Score on a scale STANDARD_DEVIATION 13.64 |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 8 Participants | 11 Participants | 39 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 11 Participants | 9 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 18 | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 11 / 20 | 11 / 18 | 16 / 20 | 18 / 19 |
| serious Total, serious adverse events | 1 / 20 | 0 / 18 | 1 / 20 | 2 / 19 |
Outcome results
Primary
Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration
Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
Time frame: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dupilumab 2mg/kg: Adolescents | Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration | 9.91 mg/L | Standard Deviation 2.15 |
| Dupilumab 2mg/kg: Children | Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration | 14.3 mg/L | Standard Deviation 5.9 |
| Dupilumab 4mg/kg: Adolescents | Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration | 23.1 mg/L | Standard Deviation 8.71 |
| Dupilumab 4mg/kg: Children | Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration | 32.4 mg/L | Standard Deviation 7.04 |
Primary
PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration
Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
Time frame: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dupilumab 2mg/kg: Adolescents | PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration | 104 Day*mg/L |
| Dupilumab 2mg/kg: Children | PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration | 160 Day*mg/L |
| Dupilumab 4mg/kg: Adolescents | PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration | 362 Day*mg/L |
| Dupilumab 4mg/kg: Children | PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration | 330 Day*mg/L |
Primary
PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose
Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.
Time frame: Pre-dose on Day 71 and Day 85
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab 2mg/kg: Adolescents | PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Day 85 | 18.5 mg/L | Standard Deviation 12.4 |
| Dupilumab 2mg/kg: Adolescents | PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Day 71 | 10.4 mg/L | Standard Deviation 7.16 |
| Dupilumab 2mg/kg: Children | PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Day 71 | 17.2 mg/L | Standard Deviation 8.44 |
| Dupilumab 2mg/kg: Children | PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Day 85 | 28 mg/L | Standard Deviation 12.9 |
| Dupilumab 4mg/kg: Adolescents | PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Day 85 | 58.8 mg/L | Standard Deviation 24.4 |
| Dupilumab 4mg/kg: Adolescents | PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Day 71 | 32.8 mg/L | Standard Deviation 18.9 |
| Dupilumab 4mg/kg: Children | PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Day 85 | 60.3 mg/L | Standard Deviation 36.3 |
| Dupilumab 4mg/kg: Children | PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose | Day 71 | 42.1 mg/L | Standard Deviation 19.4 |
Secondary
Percentage of Subjects With Investigator Global Assessment (IGA) Score of 0 or 1 (Clear or Almost Clear) at Week 12
IGA is an assessment scale used to determine severity of 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 is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF. Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used.
Time frame: Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dupilumab 2mg/kg: Adolescents | Percentage of Subjects With Investigator Global Assessment (IGA) Score of 0 or 1 (Clear or Almost Clear) at Week 12 | 10 Percentage of subjects |
| Dupilumab 2mg/kg: Children | Percentage of Subjects With Investigator Global Assessment (IGA) Score of 0 or 1 (Clear or Almost Clear) at Week 12 | 16.7 Percentage of subjects |
| Dupilumab 4mg/kg: Adolescents | Percentage of Subjects With Investigator Global Assessment (IGA) Score of 0 or 1 (Clear or Almost Clear) at Week 12 | 35 Percentage of subjects |
| Dupilumab 4mg/kg: Children | Percentage of Subjects With Investigator Global Assessment (IGA) Score of 0 or 1 (Clear or Almost Clear) at Week 12 | 21.1 Percentage of subjects |
Secondary
Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12
Body surface area 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 \[1%\]). It was reported as a percentage of all major body sections combined. Analysis was performed on SAF.
Time frame: Baseline to Week 12
Population: Here Number of participants analyzed = number of participants who were evaluated for this specific outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dupilumab 2mg/kg: Adolescents | Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12 | -61 Percentage of body surface area | Standard Deviation 31.08 |
| Dupilumab 2mg/kg: Children | Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12 | -70 Percentage of body surface area | Standard Deviation 31.93 |
| Dupilumab 4mg/kg: Adolescents | Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12 | -60.4 Percentage of body surface area | Standard Deviation 34.04 |
| Dupilumab 4mg/kg: Children | Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12 | -50 Percentage of body surface area | Standard Deviation 30.8 |
Secondary
Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
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 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF).
Time frame: Baseline to Week 12 (one week after last dose)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dupilumab 2mg/kg: Adolescents | Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | -66.4 percent change | Standard Deviation 29.25 |
| Dupilumab 2mg/kg: Children | Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | -76.2 percent change | Standard Deviation 25.48 |
| Dupilumab 4mg/kg: Adolescents | Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | -69.7 percent change | Standard Deviation 24.48 |
| Dupilumab 4mg/kg: Children | Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | -63.4 percent change | Standard Deviation 25.37 |
Secondary
Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12
Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.
Time frame: Baseline to Week 12 (one week after last dose)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dupilumab 2mg/kg: Adolescents | Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12 | -30.8 Percent change | Standard Deviation 68.35 |
| Dupilumab 2mg/kg: Children | Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12 | -41.6 Percent change | Standard Deviation 35.32 |
| Dupilumab 4mg/kg: Adolescents | Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12 | -37.6 Percent change | Standard Deviation 34.42 |
| Dupilumab 4mg/kg: Children | Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12 | -39.6 Percent change | Standard Deviation 40.88 |
Secondary
Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12
SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993). 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 \[severe disease\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.
Time frame: Baseline to Week 12 (one week after last dose)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dupilumab 2mg/kg: Adolescents | Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12 | -47.7 percent change | Standard Deviation 27.27 |
| Dupilumab 2mg/kg: Children | Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12 | -57.5 percent change | Standard Deviation 23.1 |
| Dupilumab 4mg/kg: Adolescents | Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12 | -43.4 percent change | Standard Deviation 25.38 |
| Dupilumab 4mg/kg: Children | Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12 | -46.9 percent change | Standard Deviation 24.31 |