Trial Outcomes & Findings for Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial (NCT NCT05590585)
NCT ID: NCT05590585
Last Updated: 2026-01-02
Results Overview
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 24.
COMPLETED
PHASE4
124 participants
Week 24
2026-01-02
Participant Flow
This study was conducted at a total of 30 sites located in the United States. A total of 166 participants were screened for the study, of which 124 were enrolled and were treated with dupilumab.
Participant milestones
| Measure |
Dupilumab
Participants received dupilumab by subcutaneous (SC) injection once every 2 weeks (Q2W) for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
Received at Least 1 Dose of Dupilumab
|
124
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Dupilumab
Participants received dupilumab by subcutaneous (SC) injection once every 2 weeks (Q2W) for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
Baseline characteristics by cohort
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 16.9 • n=228 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=228 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
98 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
13 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
3 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=228 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Here 'n' = number of evaluable participants at the specified timepoint.
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 24.
Outcome measures
| Measure |
Dupilumab
n=100 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75)
|
76.0 percentage of participants
Interval 66.43 to 83.98
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Percentage of participants with IGA "0" or "1" are reported at each visit.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1
Week 2
|
0.9 percentage of participants
|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1
Week 4
|
6.8 percentage of participants
|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1
Week 8
|
15.9 percentage of participants
|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1
Week 12
|
25.9 percentage of participants
|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1
Week 16
|
35.2 percentage of participants
|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1
Week 20
|
45.4 percentage of participants
|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1
Week 24
|
44.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percent Change From Baseline in EASI Score
Week 2
|
-25.929 percent change
Standard Deviation 29.782
|
|
Percent Change From Baseline in EASI Score
Week 4
|
-46.092 percent change
Standard Deviation 30.000
|
|
Percent Change From Baseline in EASI Score
Week 8
|
-67.270 percent change
Standard Deviation 25.689
|
|
Percent Change From Baseline in EASI Score
Week 12
|
-70.999 percent change
Standard Deviation 25.798
|
|
Percent Change From Baseline in EASI Score
Week 16
|
-73.276 percent change
Standard Deviation 32.975
|
|
Percent Change From Baseline in EASI Score
Week 20
|
-79.185 percent change
Standard Deviation 23.612
|
|
Percent Change From Baseline in EASI Score
Week 24
|
-79.941 percent change
Standard Deviation 25.634
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in EASI Score
Week 2
|
-7.105 score on scale
Standard Deviation 7.504
|
|
Change From Baseline in EASI Score
Week 4
|
-12.097 score on scale
Standard Deviation 9.338
|
|
Change From Baseline in EASI Score
Week 8
|
-17.779 score on scale
Standard Deviation 10.178
|
|
Change From Baseline in EASI Score
Week 12
|
-18.475 score on scale
Standard Deviation 9.768
|
|
Change From Baseline in EASI Score
Week 16
|
-19.460 score on scale
Standard Deviation 11.663
|
|
Change From Baseline in EASI Score
Week 24
|
-20.980 score on scale
Standard Deviation 11.071
|
|
Change From Baseline in EASI Score
Week 20
|
-20.985 score on scale
Standard Deviation 11.249
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to the given time point.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)
Week 2
|
17.2 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)
Week 4
|
47.9 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)
Week 8
|
77.9 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)
Week 12
|
84.3 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)
Week 16
|
84.3 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)
Week 20
|
89.7 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)
Week 24
|
89.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to the given time point.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)
Week 2
|
3.4 percentage of participants
|
|
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)
Week 4
|
23.1 percentage of participants
|
|
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)
Week 8
|
50.4 percentage of participants
|
|
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)
Week 12
|
56.5 percentage of participants
|
|
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)
Week 16
|
63.9 percentage of participants
|
|
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)
Week 20
|
74.2 percentage of participants
|
|
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)
Week 24
|
76.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to the given time point.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)
Week 2
|
0.9 percentage of participants
|
|
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)
Week 4
|
5.1 percentage of participants
|
|
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)
Week 8
|
15.0 percentage of participants
|
|
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)
Week 12
|
27.8 percentage of participants
|
|
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)
Week 16
|
38.9 percentage of participants
|
|
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)
Week 20
|
41.2 percentage of participants
|
|
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)
Week 24
|
42.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score
Week 2
|
-18.5 percent change
Standard Deviation 17.8
|
|
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score
Week 4
|
-30.2 percent change
Standard Deviation 22.6
|
|
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score
Week 8
|
-44.4 percent change
Standard Deviation 22.8
|
|
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score
Week 12
|
-50.5 percent change
Standard Deviation 23.0
|
|
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score
Week 16
|
-53.2 percent change
Standard Deviation 26.0
|
|
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score
Week 20
|
-55.6 percent change
Standard Deviation 24.3
|
|
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score
Week 24
|
-59.3 percent change
Standard Deviation 26.0
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). A decrease in score indicated improvement. SCORAD-50 was defined as ≥50% reduction from baseline in SCORAD score.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)
Week 2
|
9.1 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)
Week 4
|
16.2 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)
Week 8
|
39.3 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)
Week 12
|
52.9 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)
Week 16
|
59.8 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)
Week 20
|
68.1 percentage of participants
|
|
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)
Week 24
|
70.2 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3
Week 2
|
14.3 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3
Week 4
|
31.6 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3
Week 8
|
48.2 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3
Week 12
|
54.6 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3
Week 16
|
64.8 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3
Week 20
|
68.0 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3
Week 24
|
65.6 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4
Week 2
|
8.4 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4
Week 4
|
19.7 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4
Week 8
|
32.5 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4
Week 12
|
38.9 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4
Week 16
|
44.4 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4
Week 20
|
47.6 percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4
Week 24
|
52.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=119 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percent Change From Baseline in Weekly Average of Daily PP NRS Score
Week 2
|
-16.253 Percentage of change
Standard Deviation 25.364
|
|
Percent Change From Baseline in Weekly Average of Daily PP NRS Score
Week 4
|
-28.672 Percentage of change
Standard Deviation 28.427
|
|
Percent Change From Baseline in Weekly Average of Daily PP NRS Score
Week 8
|
-41.010 Percentage of change
Standard Deviation 33.346
|
|
Percent Change From Baseline in Weekly Average of Daily PP NRS Score
Week 12
|
-45.944 Percentage of change
Standard Deviation 31.358
|
|
Percent Change From Baseline in Weekly Average of Daily PP NRS Score
Week 16
|
-52.706 Percentage of change
Standard Deviation 30.812
|
|
Percent Change From Baseline in Weekly Average of Daily PP NRS Score
Week 20
|
-54.138 Percentage of change
Standard Deviation 28.698
|
|
Percent Change From Baseline in Weekly Average of Daily PP NRS Score
Week 24
|
-56.337 Percentage of change
Standard Deviation 31.036
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=119 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in Weekly Average of Daily PP NRS Score
Week 2
|
-1.234 score on a scale
Standard Deviation 1.663
|
|
Change From Baseline in Weekly Average of Daily PP NRS Score
Week 4
|
-2.058 score on a scale
Standard Deviation 2.021
|
|
Change From Baseline in Weekly Average of Daily PP NRS Score
Week 8
|
-2.939 score on a scale
Standard Deviation 2.379
|
|
Change From Baseline in Weekly Average of Daily PP NRS Score
Week 12
|
-3.237 score on a scale
Standard Deviation 2.266
|
|
Change From Baseline in Weekly Average of Daily PP NRS Score
Week 16
|
-3.741 score on a scale
Standard Deviation 2.369
|
|
Change From Baseline in Weekly Average of Daily PP NRS Score
Week 20
|
-3.823 score on a scale
Standard Deviation 2.184
|
|
Change From Baseline in Weekly Average of Daily PP NRS Score
Week 24
|
-3.981 score on a scale
Standard Deviation 2.326
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
BSA affected by AD was assessed for each section of the body using the rule of nines (the possible highest score for each region was: head and neck \[9%\], interior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]). BSA was reported as a percentage of all major body sections combined.
Outcome measures
| Measure |
Dupilumab
n=120 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percent Change From Baseline in Percent Body Surface Area (BSA)
Week 2
|
-17.91 Percentage of change
Standard Deviation 24.92
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA)
Week 4
|
-31.07 Percentage of change
Standard Deviation 31.06
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA)
Week 8
|
-53.09 Percentage of change
Standard Deviation 30.67
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA)
Week 12
|
-60.04 Percentage of change
Standard Deviation 31.45
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA)
Week 16
|
-64.65 Percentage of change
Standard Deviation 32.79
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA)
Week 20
|
-71.03 Percentage of change
Standard Deviation 28.50
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA)
Week 24
|
-73.69 Percentage of change
Standard Deviation 28.31
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on QOL; over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL). A decrease in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=94 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score
Week 24
|
-8.3 score on a scale
Standard Deviation 7.1
|
|
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score
Week 2
|
-4.5 score on a scale
Standard Deviation 5.4
|
|
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score
Week 4
|
-5.6 score on a scale
Standard Deviation 7.1
|
|
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score
Week 8
|
-6.7 score on a scale
Standard Deviation 6.5
|
|
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score
Week 12
|
-7.6 score on a scale
Standard Deviation 5.7
|
|
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score
Week 16
|
-7.6 score on a scale
Standard Deviation 6.7
|
|
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score
Week 20
|
-8.5 score on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
CDLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL) in children. A decrease in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=10 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score
Week 2
|
-4.2 score on a scale
Standard Deviation 5.4
|
|
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score
Week 4
|
-5.0 score on a scale
Standard Deviation 5.2
|
|
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score
Week 8
|
-5.1 score on a scale
Standard Deviation 4.2
|
|
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score
Week 12
|
-6.3 score on a scale
Standard Deviation 7.0
|
|
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score
Week 16
|
-8.5 score on a scale
Standard Deviation 5.6
|
|
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score
Week 20
|
-8.6 score on a scale
Standard Deviation 5.4
|
|
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score
Week 24
|
-7.8 score on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (Higher score indicative of more severe symptoms). Total score was an average of the disease symptoms assessed. A decrease in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=104 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
Week 2
|
-5.6 score on a scale
Standard Deviation 6.0
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
Week 4
|
-8.3 score on a scale
Standard Deviation 6.6
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
Week 8
|
-10.3 score on a scale
Standard Deviation 6.5
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
Week 12
|
-11.0 score on a scale
Standard Deviation 6.3
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
Week 16
|
-11.2 score on a scale
Standard Deviation 7.0
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
Week 20
|
-11.3 score on a scale
Standard Deviation 7.0
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
Week 24
|
-11.5 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The Hospital Anxiety and Depression Scale (HADS) is a screening tool designed to assess anxiety and depression. The scale consists of 14 items, divided into two subscales: Anxiety (HADS-A): 7 items; Depression (HADS-D): 7 items. The range of the total score is 0-42 (sum of HADS-A and HADS-D), with higher score indicating more severe overall psychological distress. The two subscales can be reported separately, each with a score range of 0-21, with higher score indicating more severe symptoms of anxiety or depression. A decrease in either the total score or a subscale score indicates improvement.
Outcome measures
| Measure |
Dupilumab
n=104 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score
Week 2
|
-1.8 score on a scale
Standard Deviation 5.0
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score
Week 4
|
-2.3 score on a scale
Standard Deviation 5.5
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score
Week 8
|
-2.8 score on a scale
Standard Deviation 5.6
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score
Week 12
|
-3.7 score on a scale
Standard Deviation 5.5
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score
Week 16
|
-3.4 score on a scale
Standard Deviation 5.8
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score
Week 20
|
-3.4 score on a scale
Standard Deviation 6.1
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score
Week 24
|
-3.2 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
SP NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants selected the number between 0 and 10 that fit best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain imaginable). A decrease in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=104 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in Skin Pain NRS (SP NRS) Score
Week 20
|
-3.0 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in Skin Pain NRS (SP NRS) Score
Week 16
|
-3.0 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in Skin Pain NRS (SP NRS) Score
Week 2
|
-2.3 score on a scale
Standard Deviation 3.6
|
|
Change From Baseline in Skin Pain NRS (SP NRS) Score
Week 4
|
-2.6 score on a scale
Standard Deviation 4.0
|
|
Change From Baseline in Skin Pain NRS (SP NRS) Score
Week 8
|
-3.2 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Skin Pain NRS (SP NRS) Score
Week 12
|
-3.3 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Skin Pain NRS (SP NRS) Score
Week 24
|
-2.9 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicated worst possible sleep while 10 indicated best possible sleep. An increase in score indicated improvement.
Outcome measures
| Measure |
Dupilumab
n=119 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in Weekly Average Sleep Quality NRS Score
Week 2
|
0.473 score on a scale
Standard Deviation 1.565
|
|
Change From Baseline in Weekly Average Sleep Quality NRS Score
Week 4
|
0.910 score on a scale
Standard Deviation 1.937
|
|
Change From Baseline in Weekly Average Sleep Quality NRS Score
Week 8
|
1.204 score on a scale
Standard Deviation 2.459
|
|
Change From Baseline in Weekly Average Sleep Quality NRS Score
Week 12
|
1.281 score on a scale
Standard Deviation 2.173
|
|
Change From Baseline in Weekly Average Sleep Quality NRS Score
Week 16
|
1.239 score on a scale
Standard Deviation 2.097
|
|
Change From Baseline in Weekly Average Sleep Quality NRS Score
Week 20
|
1.045 score on a scale
Standard Deviation 2.631
|
|
Change From Baseline in Weekly Average Sleep Quality NRS Score
Week 24
|
1.210 score on a scale
Standard Deviation 2.696
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of "No symptoms" at the specified timepoints.
Outcome measures
| Measure |
Dupilumab
n=104 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms
Week 2
|
4.0 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms
Week 4
|
4.0 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms
Week 8
|
14.6 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms
Week 12
|
10.0 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms
Week 16
|
12.0 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms
Week 20
|
14.3 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms
Week 24
|
23.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of "No symptoms" or "Mild symptoms" at the specified timepoints.
Outcome measures
| Measure |
Dupilumab
n=104 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms
Week 2
|
26.7 percentage of participants
|
|
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms
Week 4
|
46.0 percentage of participants
|
|
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms
Week 8
|
59.4 percentage of participants
|
|
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms
Week 12
|
65.6 percentage of participants
|
|
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms
Week 16
|
68.5 percentage of participants
|
|
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms
Week 20
|
64.3 percentage of participants
|
|
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms
Week 24
|
67.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) "much better" to (7) "much worse", with (4) = "no change". Data are reported for the percentage of participants who rated their eczema symptoms as "Much better" at the specified timepoints.
Outcome measures
| Measure |
Dupilumab
n=114 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"
Week 2
|
15.8 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"
Week 4
|
23.7 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"
Week 8
|
44.1 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"
Week 12
|
45.6 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"
Week 16
|
50.5 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"
Week 20
|
55.2 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"
Week 24
|
53.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) "much better" to (7) "much worse", with (4) = "no change". Data are reported for the percentage of participants who rated their eczema symptoms as "Moderately better" at the specified timepoints.
Outcome measures
| Measure |
Dupilumab
n=114 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"
Week 2
|
14.0 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"
Week 4
|
27.2 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"
Week 8
|
23.4 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"
Week 12
|
28.2 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"
Week 16
|
27.6 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"
Week 20
|
25.0 percentage of participants
|
|
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"
Week 24
|
23.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 through Week 24Population: Safety Set: All participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Data are reported for the number of participants with non-herpetic skin infection TEAEs. A summary of all serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Dupilumab
n=124 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs)
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
Serum samples were collected to measure concentrations of IgE.
Outcome measures
| Measure |
Dupilumab
n=107 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Change From Baseline in Total Immunoglobulin (E) IgE
Week 4
|
-493.277 kU/L
Standard Deviation 1964.991
|
|
Change From Baseline in Total Immunoglobulin (E) IgE
Week 12
|
-2284.021 kU/L
Standard Deviation 5579.402
|
|
Change From Baseline in Total Immunoglobulin (E) IgE
Week 24
|
-3177.471 kU/L
Standard Deviation 6959.014
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 24Population: Here 'n' = Number of evaluable participants at the specified timepoint.
Serum samples were collected to measure concentrations of IgE.
Outcome measures
| Measure |
Dupilumab
n=115 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Percent Change From Baseline in Total IgE
Week 4
|
-6.277 percent change
Standard Deviation 62.301
|
|
Percent Change From Baseline in Total IgE
Week 12
|
-39.703 percent change
Standard Deviation 25.145
|
|
Percent Change From Baseline in Total IgE
Week 24
|
-50.375 percent change
Standard Deviation 69.291
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: Pharmacokinetic (PK) Analysis Set: All participants who received any study drug and who had at least 1 non-missing PK result following the first dose of any study drug. Analysis was based on the treatment received. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed' = participants evaluable at specified timepoint.
Adolescents and adults received 1 of 2 dose regimens based on age and body weight. The trough concentration of functional dupilumab in serum for the 2 dose regimens at the specified time points are presented. Participants treated and had at least one evaluable post-first-dose concentration measurement.
Outcome measures
| Measure |
Dupilumab
n=114 Participants
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Trough Concentration of Functional Dupilumab in Serum
Dose Regimen 1: Week 24
|
43.9 mg/L
Standard Deviation 28.0
|
|
Trough Concentration of Functional Dupilumab in Serum
Dose Regimen 2: Week 24
|
49.6 mg/L
Standard Deviation 33.4
|
|
Trough Concentration of Functional Dupilumab in Serum
Dose Regimen 1: Week 12
|
40.8 mg/L
Standard Deviation 28.7
|
|
Trough Concentration of Functional Dupilumab in Serum
Dose Regimen 2: Week 12
|
43.9 mg/L
Standard Deviation 28.4
|
Adverse Events
Dupilumab
Serious adverse events
| Measure |
Dupilumab
n=124 participants at risk
Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Infections and infestations
Septic shock
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Infections and infestations
Sinusitis
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Nervous system disorders
Encephalopathy
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Nervous system disorders
Seizure
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Gastrointestinal disorders
Intussusception
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Investigations
Blood pressure increased
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.81%
1/124 • Number of events 1 • Day 1 through Week 24
Safety Set: all participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER