| Primary | Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 | IGA is an assessment scale used to determine severity of hand and foot 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. Higher score is indicative of more severe disease. | | Posted | | Number | | Percentage of participants | | At week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | | =0.0030 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16 | Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | | Posted | | Number | | Percentage of participants | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16 | Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | | Posted | | Number | | Percentage of participants | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage of change | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16 | mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease). | The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage of change | | Baseline to Week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS | Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible). | The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS | Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep. | The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD) | | The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Least Squares Mean | Standard Error | Percentage of hand and foot BSA | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage of change | | Baseline to week 4 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4 | Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Number | | Percentage of participants | | Baseline to week 4 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis | For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The range for the combined HECSI score is from 0 to 360 (5x6x3x4). | | Posted | | Mean | Standard Deviation | Percentage of change | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percentage of Participants With HECSI-75 at Week 16 | HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis. | Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Number | | Percentage of participants | | At week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percentage of Participants With HECSI-50 at Week 16 | HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis. | Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Number | | Percentage of participants | | At week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percentage of Participants With HECSI-90 at Week 16 | HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis. | Efficacy analyses was based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Number | | Percentage of participants | | At week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) | For participants with hand dermatitis, QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in those suffering from hand eczema. QOLHEQ overall scoring ranges as follows: 0 (best score) to 117 (worst score). | Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ) | WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all. | | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline to week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16 | | The safety analysis set (SAF) includes all randomized patients who receive at least one dose of study drug and will be analyzed as treated. | Posted | | Number | | Percentage of participants | | Through week 16 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered SC Q2W, following a loading dose on Day 1 |
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| Secondary | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | | The pharmacokinetic analysis set (PKAS) includes all treated participants who received any amount of study drug (active or placebo [SAF]) and had at least 1 non-missing dupilumab measurement following the first dose of study drug or placebo. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Here 'n' = number of evaluable participants at a specified point in time | Posted | | Mean | Standard Deviation | Milligrams per Liter (mg/L) | | Up to week 28 | | | | ID | Title | Description |
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| OG000 | Dupilumab 300 mg - Adult Participants | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab 200 mg - Adolescent Participants | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG002 | Dupilumab 300 mg - Adolescent Participants | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 |
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| Secondary | Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA) | | The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo [safety analysis set]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (active drug or placebo) rather than as randomized. Here 'n'= number of evaluable participants at a specified point in time. | Posted | | Number | | Participants | | Up to week 28 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 |
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| Secondary | Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | | The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo [safety analysis set]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (active drug or placebo) rather than as randomized. Here 'n'= number of evaluable participants at a specified point in time. | Posted | | Number | | Participants | | Up to Week 28 | | | | ID | Title | Description |
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| OG000 | Matching Placebo | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | | OG001 | Dupilumab Q2W | Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 |
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