Moderate to Severe Atopic Hand and Foot Dermatitis
Conditions
Brief summary
The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis. The secondary objectives of the study are: * To assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep loss, health related QoL, work life impairment) in patients with atopic hand and foot dermatitis * To evaluate the safety and tolerability of dupilumab administered to patients with atopic hand and foot dermatitis * To evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic hand and foot dermatitis
Interventions
DRUGdupilumab
Solution for subcutaneous (SC) injection administration
DRUGPlacebo
Solution for SC injection administration
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patients with involvement of at least 2 anatomical areas at screening and baseline * Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline * Patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s) * Patients meet the diagnosis criteria for atopic dermatitis (AD) * Provide informed consent/assent signed by study patient or legally acceptable representative * Patients need to have been compliant with the skin protection measures through the entire duration of the screening period Key
Exclusion criteria
* Treatment with dupilumab in the past * Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis * Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis * Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline * Known history of HIV/HBV/HCV infection * Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study * Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study NOTE: Other protocol defined inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16 | 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). |
| Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | 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). |
| Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16 | 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). |
| Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS | Baseline to week 16 | 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). |
| Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS | Baseline to week 16 | Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep. |
| Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD) | Baseline to week 16 | — |
| Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | 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). |
| Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4 | 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). |
| Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis | Baseline to week 16 | 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). |
| 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 | 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). |
| Percentage of Participants With HECSI-50 at Week 16 | At week 16 | HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis. |
| Percentage of Participants With HECSI-90 at Week 16 | At week 16 | HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis. |
| Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) | Baseline to week 16 | 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). |
| Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ) | Baseline to week 16 | 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. |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16 | Through week 16 | — |
| Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Up to week 28 | — |
| Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA) | Up to week 28 | — |
| Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | Up to Week 28 | — |
| Percentage of Participants With HECSI-75 at Week 16 | At week 16 | HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis. |
Countries
Germany, Japan, Poland, United States
Participant flow
Pre-assignment details
A total of 170 participants were screened, 37 participants failed screening, and 133 participants were randomized. Of the 37 screen failures: 2 withdrew consent, 33 did not meet inclusion/exclusion criteria, 1 was lost to follow-up and 1 was for an unknown reason.
Participants by arm
| Arm | Count |
|---|---|
| Matching Placebo Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 | 66 |
| Dupilumab Q2W Administered SC Q2W, following a loading dose on Day 1 | 67 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 3 | 1 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 6 |
Baseline characteristics
| Characteristic | Matching Placebo | Dupilumab Q2W | Total |
|---|---|---|---|
| Age, Continuous | 33.4 Years STANDARD_DEVIATION 14.66 | 35.8 Years STANDARD_DEVIATION 17.07 | 34.6 Years STANDARD_DEVIATION 15.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 64 Participants | 127 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 9 Participants | 17 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 53 Participants | 53 Participants | 106 Participants |
| Sex: Female, Male Female | 38 Participants | 45 Participants | 83 Participants |
| Sex: Female, Male Male | 28 Participants | 22 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 67 |
| other Total, other adverse events | 34 / 66 | 33 / 67 |
| serious Total, serious adverse events | 1 / 66 | 3 / 67 |
Outcome results
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.
Time frame: At week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 | 16.7 Percentage of participants |
| Dupilumab Q2W | Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 | 40.3 Percentage of participants |
p-value: =0.003Cochran-Mantel-Haenszel
Secondary
Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)
Time frame: Baseline to week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD) | -10.01 Percentage of hand and foot BSA | Standard Error 2.388 |
| Dupilumab Q2W | Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD) | -16.70 Percentage of hand and foot BSA | Standard Error 2.375 |
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).
Time frame: Baseline to week 16
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) | -13.36 Score on a scale | Standard Deviation 21.222 |
| Dupilumab Q2W | Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) | -38.70 Score on a scale | Standard Deviation 23.92 |
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).
Time frame: Baseline to week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS | -1.93 Score on a scale | Standard Error 0.432 |
| Dupilumab Q2W | Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS | -4.66 Score on a scale | Standard Error 0.426 |
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.
Time frame: Baseline to week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS | -0.00 Score on a scale | Standard Error 0.335 |
| Dupilumab Q2W | Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS | 0.88 Score on a scale | Standard Error 0.334 |
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.
Time frame: Baseline to week 16
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ) | -21.26 Score on a scale | Standard Error 3.761 |
| Dupilumab Q2W | Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ) | -36.39 Score on a scale | Standard Error 3.649 |
Secondary
Number of Participants With Treatment-Emergent ADA by Maximum Titer Category
Time frame: Up to Week 28
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo | Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | Low (<1,000) | 1 Participants |
| Matching Placebo | Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | Moderate (1,000 to 10,000) | 0 Participants |
| Matching Placebo | Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | High (>10,000) | 0 Participants |
| Dupilumab Q2W | Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | Low (<1,000) | 8 Participants |
| Dupilumab Q2W | Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | Moderate (1,000 to 10,000) | 0 Participants |
| Dupilumab Q2W | Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | High (>10,000) | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)
Time frame: Up to week 28
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo | Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA) | Treatment-Boosted Response | 0 Participants |
| Matching Placebo | Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA) | Treatment-Emergent Response | 1 Participants |
| Dupilumab Q2W | Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA) | Treatment-Boosted Response | 0 Participants |
| Dupilumab Q2W | Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA) | Treatment-Emergent Response | 8 Participants |
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.
Time frame: At week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | Percentage of Participants With HECSI-50 at Week 16 | 30.8 Percentage of participants |
| Dupilumab Q2W | Percentage of Participants With HECSI-50 at Week 16 | 75.0 Percentage of participants |
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.
Time frame: At week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | Percentage of Participants With HECSI-75 at Week 16 | 21.5 Percentage of participants |
| Dupilumab Q2W | Percentage of Participants With HECSI-75 at Week 16 | 46.9 Percentage of participants |
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.
Time frame: At week 16
Population: Efficacy analyses was based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | Percentage of Participants With HECSI-90 at Week 16 | 9.2 Percentage of participants |
| Dupilumab Q2W | Percentage of Participants With HECSI-90 at Week 16 | 18.8 Percentage of participants |
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).
Time frame: Baseline to week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16 | 16.7 Percentage of participants |
| Dupilumab Q2W | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16 | 61.2 Percentage of participants |
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).
Time frame: Baseline to week 4
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4 | 9.1 Percentage of participants |
| Dupilumab Q2W | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4 | 34.3 Percentage of participants |
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).
Time frame: Baseline to week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | 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 | 13.6 Percentage of participants |
| Dupilumab Q2W | 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 | 52.2 Percentage of participants |
p-value: <0.000195% CI: [24.06, 53.15]Mantel Haenszel
Secondary
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16
Time frame: Through week 16
Population: The safety analysis set (SAF) includes all randomized patients who receive at least one dose of study drug and will be analyzed as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16 | 74.2 Percentage of participants |
| Dupilumab Q2W | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16 | 65.7 Percentage of participants |
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).
Time frame: Baseline to week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis | -33.8 Percentage of change | Standard Deviation 42.21 |
| Dupilumab Q2W | Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis | -68.2 Percentage of change | Standard Deviation 25.56 |
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).
Time frame: Baseline to week 16
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Matching Placebo | Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | -26.2 Percentage of change |
| Dupilumab Q2W | Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | -62.9 Percentage of change |
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).
Time frame: Baseline to week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Matching Placebo | Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | -25.6 Percentage of change |
| Dupilumab Q2W | Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | -47.2 Percentage of change |
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).
Time frame: Baseline to Week 16
Population: The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Matching Placebo | Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16 | -31.0 Percentage of change |
| Dupilumab Q2W | Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16 | -69.4 Percentage of change |
Secondary
Trough Concentration of Functional Dupilumab in Serum at Various Time Points
Time frame: Up to week 28
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 16 | 51.2 Milligrams per Liter (mg/L) | Standard Deviation 22 |
| Matching Placebo | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 0 | 0 Milligrams per Liter (mg/L) | Standard Deviation 0 |
| Matching Placebo | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 28 | 7.37 Milligrams per Liter (mg/L) | Standard Deviation 25 |
| Dupilumab Q2W | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 16 | 34.0 Milligrams per Liter (mg/L) | Standard Deviation 10.7 |
| Dupilumab Q2W | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 28 | 60.0 Milligrams per Liter (mg/L) | Standard Deviation 84.9 |
| Dupilumab Q2W | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 0 | 0 Milligrams per Liter (mg/L) | Standard Deviation 0 |
| Dupilumab 300 mg - Adolescent Participants | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 0 | 0 Milligrams per Liter (mg/L) | Standard Deviation 0 |
| Dupilumab 300 mg - Adolescent Participants | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 28 | 7.54 Milligrams per Liter (mg/L) | Standard Deviation 16.9 |
| Dupilumab 300 mg - Adolescent Participants | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Week 16 | 37.1 Milligrams per Liter (mg/L) | Standard Deviation 15.9 |