| Primary | Part A: Maximum Observed Serum Concentration (Cmax) of Functional Dupilumab | Serum concentration of functional dupilumab was reported. | The Pharmacokinetic Analysis Set (PKAS) included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug. | Posted | | Mean | Standard Deviation | Milligrams per Liter (mg/L) | | Post-dose on Days 1, 3, 8, 18, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG002 | Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG003 | Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. |
| | Units | Counts |
|---|
| Participants | - OG0009
- OG00110
- OG00210
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00025.2± 7.44(7.44 to )
- OG00149.8± 11.3(11.3 to )
- OG00220.1± 6.81(6.81 to )
|
|
| |
| Primary | Part A: Dose Normalized Maximum Observed Serum Concentration (Cmax/Dose) of Dupilumab | Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in Milligrams per Liter/Milligrams per Kilogram ([mg/L]/[mg/kg]). | The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug. | Posted | | Mean | Standard Deviation | [mg/L]/[mg/kg] | | Post-dose on Days 1, 3, 8, 18, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | |
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| Primary | Part A: Time to Reach the Maximum Serum Concentration (Tmax) of Dupilumab | Tmax was obtained directly from the concentration versus time curve. | The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug. | Posted | | Median | Full Range | Days | | Post-dose on Days 1, 3, 8, 18, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG002 | Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg |
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| Primary | Part A: Last Quantifiable Serum Concentration (Clast) of Dupilumab | Clast is the last measurable serum concentration of dupilumab. | The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug. | Posted | | Mean | Standard Deviation | mg/L | | Post-dose on Days 1, 3, 8, 18, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG002 | Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg |
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| Primary | Part A: Time of the Last Quantifiable Serum Concentration (Tlast) of Dupilumab | Tlast was defined as the last time point with a measurable serum concentration of dupilumab. | The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug. | Posted | | Median | Full Range | Days | | Post-dose on Days 1, 3, 8, 18, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG002 | Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg |
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| Primary | Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Dupilumab | AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration. | The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug. | Posted | | Mean | Standard Deviation | Days*Milligrams per Liter (day*mg/L) | | Post-dose on Days 1, 3, 8, 18, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | |
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| Primary | Part A: Dose Normalized Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast/Dose) of Dupilumab | Dose normalized AUClast was calculated by AUClast/dose. | The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug. | Posted | | Mean | Standard Deviation | [day*mg/L]/[mg/kg] | | Post-dose on Days 1, 3, 8, 18, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG002 |
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| Primary | Part A: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE was defined as AE starting/worsening after first intake of study drug. TEAEs included participants with both SAEs and non-SAEs. Number of participants with TEAEs is reported. | The safety analysis set (SAF) included all participants who received any study drug and were analyzed based on the actual treatment received. | Posted | | Count of Participants | | Participants | | Baseline up to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. |
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| Primary | Part A: Number of Participants With TEAEs by Severity According to Qualitative Toxicity Scale | Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported. | The SAF included all participants who received any study drug and were analyzed based on the actual treatment received. | Posted | | Count of Participants | | Participants | | Baseline up to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. |
|
| Primary | Part B: Percentage of Participants With Investigator's Global Assessment (IGA) Score 0 or 1 at Week 16 | The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1=almost clear; 2=mild; 3=moderate; 4=severe. A negative change from baseline indicated improvement. Percentage of participants with IGA score of '0' or '1' is reported. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, adverse event (AE), lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using multiple imputation (MI). Participants were considered as non-responders after initiation of rescue treatment. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
|
| Primary | Part B: Percentage of Participants With Eczema Area and Severity Index (EASI) -75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 | The EASI score is used to measure the severity and extent of AD and measured 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 indicating the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline at Week 16. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS |
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| Secondary | Part A: Number of Participants With Serious TEAEs and Severe TEAEs | Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Severe TEAE: significant impairment of functioning the participant is unable to carry out his or her usual activities. | The SAF included all participants who received any study drug and was analyzed based on the actual treatment received. | Posted | | Count of Participants | | Participants | | Baseline up to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. |
|
| Secondary | Part A: Percent Change From Baseline in EASI Score at Week 4 | The EASI score is used to measure the severity and extent of AD and measured 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 indicated the worse severity of AD. A negative change from baseline indicated improvement. | The SAF included all participants who received any study drug and was analyzed based on the actual treatment received. | Posted | | Mean | Standard Deviation | Percent Change | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. |
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| Secondary | Part A: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 4 | The SCORAD is used to assess the extent and severity of AD. Extent and severity of eczema as well as subjective symptoms (insomnia, etc) were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease). A negative change from baseline indicated improvement. | SAF included all participants who received any study drug and was analyzed based on the actual treatment received. | Posted | | Mean | Standard Deviation | Percent Change | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG002 |
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| Secondary | Part A: Percentage of Participants With IGA Score 0 or 1 at Week 4 | The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. Percentage of participants with IGA score of '0' or '1' were reported. | SAF included all participants who received any study drug and was analyzed based on the actual treatment received. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG002 |
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| Secondary | Part A: Number of Participants With at Least One Positive Treatment-Emergent Anti-Drug Antibodies (ADA) | Treatment boosted (TB) Response: Any post-dose positive result at least 9-fold over the baseline level when baseline is positive; Treatment emergent (TE) Response: Post-dose positive result when baseline results were negative. | The ADA Analysis Set (AAS) included all treated participants who received any study drug and who had at least 1 non-missing ADA result following the first dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | | OG001 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | |
|
| Secondary | Part B: Number of Participants With at Least One Serious Adverse Event (SAE) Through Week 16 | | SAF included all randomized participants who received at least one dose of study drug and was analysed as treated. | Posted | | Count of Participants | | Participants | | Baseline through Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
| |
| Secondary | Part B: Number of Participants With at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infection) Through Week 16 | | SAF included all randomized participants who received at least one dose of study drug and was analysed as treated. | Posted | | Count of Participants | | Participants | | Baseline through Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
| |
| Secondary | Part B: Number of Participants With at Least One Positive Treatment-Emergent ADA | Treatment emergent (TE): Post-dose positive result when baseline results were negative. | AAS included all participants who received any study drug and who had at least one non-missing ADA result after the first dose of the study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Day 197 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
|
| Secondary | Part B: Percent Change From Baseline in EASI Score at Week 16 | The EASI score is 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 indicating the worse severity of AD. A negative change from baseline indicated improvement. | FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomisation (as randomised). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline worst observation carried forward (WOCF). If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | |
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| Secondary | Part B: Percent Change From Baseline in Weekly Average of Daily Worst Scratch/Itch/Numerical Rating Scale (NRS) at Week 16 | Pruritus NRS is an assessment tool used to report intensity of participant's pruritus (itch), both average & maximum intensity, during 24-hr recall period. Participants were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch & 10=worst itch imaginable. A negative change from baseline indicated improvement. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | |
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| Secondary | Part B: Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Scratch/Itch/NRS ≥4 Points at Week 16 | Pruritus NRS is an assessment tool used to report intensity of subject's pruritus (itch), both average & maximum intensity, during 24-hr recall period. Subjects were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; & 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch & 10=worst itch imaginable. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 |
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| Secondary | Part B: Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Scratch/Itch/NRS ≥3 Points at Week 16 | Pruritus NRS is an assessment tool used to report intensity of participant's pruritus (itch), both average & maximum intensity, during 24-hr recall period. Participants were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; & 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch & 10=worst itch imaginable. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 |
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| Secondary | Part B: Percentage of Participants Who Achieved EASI-50 (≥50% Improvement From Baseline) at Week 16 | The EASI score is used to measure the severity and extent of AD and measured 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 indicating the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline at Week 16. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS |
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| Secondary | Part B: Percentage of Participants Who Achieved EASI-90 (≥90% Improvement From Baseline) at Week 16 | The EASI score is used to measure the severity and extent of AD and measured 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 indicating the worse severity of AD. EASI-90 responders were the participant who achieved ≥90% overall improvement in EASI score from baseline at Week 16. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS |
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| Secondary | Part B: Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16 | 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%]). It was reported as a percentage of all major body sections combined. A negative change from baseline indicated improvement. | The FAS included all randomized participant. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Percentage of Body Surface Area (BSA) | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | |
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| Secondary | Part B: Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 | The 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) (high score indicative of poor quality of life [QOL]). A negative change from baseline indicated improvement. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
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| Secondary | Part B: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). 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). A negative change from baseline indicated improvement. | The FAS included all randomized participant. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
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| Secondary | Part B: Change From Baseline in Participant's Sleep Quality NRS at Week 16 | A sleep diary is completed by the parent/caregiver, included 2 questions assessing the caregiver's sleep, and 6 questions assessing the child's sleep based on caregiver observation. Sleep diary items, either alone or in combination serve as subjective measures of sleep quality, difficulty falling asleep, nighttime awakenings, and sleep duration. Sleep quality is measured using an 11-point NRS (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS |
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| Secondary | Part B: Change From Baseline in Participant's Skin Pain NRS at Week 16 | Skin pain was assessed by the parent/caregiver and measured using a 11-point scale (0 to 10) in which 0 indicated no pain while 10 indicated worst pain possible. A negative change from baseline indicated improvement. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
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| Secondary | Part B: Change From Baseline in Dermatitis Family Index (DFI) at Week 16 | DFI is a 10-item questionnaire with items inquiring about housework, food preparation, sleep, family leisure activity, shopping, expenditure, tiredness, emotional distress, relationships, and impact of helping with treatment on the primary caregiver's life. DFI questions were scored on a four-point Likert scale ranging from 0 to 3, so that the total DFI score ranges from 0 to 30. Timeframe of reference was the past week. A higher DFI score indicated greater impairment in family Quality of life (QOL) as affected by atopic dermatitis. A negative change from baseline indicated improvement. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | |
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| Secondary | Part B: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 | CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 |
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| Secondary | Part B: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 | Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach. | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS |
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| Secondary | Part B: Percentage of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16 | Percentage of TCS medication-free days was calculated as the number of days that a subject used neither TCS/TCI nor system rescue therapy divided by the study days. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). | Posted | | Median | Full Range | Percentage of Days | | Baseline up to Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
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| Secondary | Part B: Mean Weekly Dose of Low Potency TCS in Grams From Baseline to Week 16 | Mean weekly dose of TCS in grams/week for low potency TCS from baseline to Week 16 is reported. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). | Posted | | Least Squares Mean | Standard Error | Grams per Week | | Baseline up to Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
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| Secondary | Part B: Mean Weekly Dose of TCS in Grams for Medium or High Potency TCS From Baseline to Week 16 | Mean weekly dose of TCS in grams/week for medium or high potency TCS from baseline to Week 16 is reported. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). | Posted | | Least Squares Mean | Standard Error | Grams per Week | | Baseline up to Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
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| Secondary | Part B: Mean Number of Caregiver Missed Work Days Through Week 16 | Mean of number of caregiver missed work days through Week 16 is reported. | The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). | Posted | | Mean | Standard Deviation | Days | | Baseline through Week 16 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study [EOS] period). | | OG001 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to < 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to < 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). |
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