Trial Outcomes & Findings for A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD) (NCT NCT02395133)
NCT ID: NCT02395133
Last Updated: 2020-03-11
Results Overview
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Difference of percent change in EASI between current study baseline and week 36 in from parent study baseline (NCT02277743 and NCT02277769) was reported. Values after first rescue treatment used were set to missing before multiple imputation (MI).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
422 participants
Primary outcome timeframe
Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study)
Results posted on
2020-03-11
Participant Flow
The study was conducted in 15 countries between 25 March 2015 and 18 October 2016. A total of 422 participants were randomized in the study.
Out of the 475 participants, 422 were randomized and 420 received either placebo or Dupilumab. Participants were randomized in 2:1:1:1 ratio to receive Dupilumab 300 milligram (mg) once weekly/twice weekly (QW/Q2W), Dupilumab 300 mg four times a week (Q4W), Dupilumab 300 mg eight times a week (Q8W) and Placebo.
Participant milestones
| Measure |
Placebo QW
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
84
|
86
|
169
|
|
Overall Study
COMPLETED
|
69
|
75
|
76
|
155
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
10
|
14
|
Reasons for withdrawal
| Measure |
Placebo QW
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
3
|
0
|
|
Overall Study
Consent withdrawn with no reason given
|
1
|
3
|
0
|
2
|
|
Overall Study
Consent withdrawn with personal reason
|
0
|
1
|
0
|
3
|
|
Overall Study
Sponsor decision
|
2
|
0
|
0
|
1
|
|
Overall Study
Other than specified above
|
5
|
2
|
2
|
4
|
Baseline Characteristics
A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)
Baseline characteristics by cohort
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
Total
n=422 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 13.98 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 16.76 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 13.94 • n=4 Participants
|
38.2 years
STANDARD_DEVIATION 14.46 • n=21 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
195 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
227 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
396 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
298 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
North America
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
192 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Eczema Area and Severity Index (EASI) Score
|
2.5 units on a scale
STANDARD_DEVIATION 2.31 • n=5 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 2.33 • n=7 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 3.31 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 2.92 • n=4 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 2.78 • n=21 Participants
|
|
Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS)
|
2.8 units on a scale
STANDARD_DEVIATION 2.11 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 2.27 • n=7 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 2.16 • n=5 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 1.92 • n=4 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 2.08 • n=21 Participants
|
|
Body Surface Area (BSA) Involvement with AD
|
8.1 percentage of body surface area
STANDARD_DEVIATION 8.21 • n=5 Participants
|
7.9 percentage of body surface area
STANDARD_DEVIATION 9.04 • n=7 Participants
|
9.3 percentage of body surface area
STANDARD_DEVIATION 10.51 • n=5 Participants
|
7.9 percentage of body surface area
STANDARD_DEVIATION 9.02 • n=4 Participants
|
8.2 percentage of body surface area
STANDARD_DEVIATION 9.18 • n=21 Participants
|
|
SCORing Atopic Dermatitis (SCORAD) Score
|
16.8 units on a scale
STANDARD_DEVIATION 10.03 • n=5 Participants
|
17.1 units on a scale
STANDARD_DEVIATION 9.41 • n=7 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 10.59 • n=5 Participants
|
17.1 units on a scale
STANDARD_DEVIATION 10.49 • n=4 Participants
|
17.1 units on a scale
STANDARD_DEVIATION 10.18 • n=21 Participants
|
|
Patient Oriented Eczema Measure (POEM)
|
6.1 units on a scale
STANDARD_DEVIATION 5.43 • n=5 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 5.88 • n=7 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 5.11 • n=5 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 5.30 • n=4 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 5.40 • n=21 Participants
|
|
Dermatology Life Quality Index (DLQI) Score
|
3.4 units on a scale
STANDARD_DEVIATION 4.25 • n=5 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 3.76 • n=7 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 3.93 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 4.21 • n=4 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 4.06 • n=21 Participants
|
|
Total Hospital Anxiety Depression Scale (HADS)
|
5.9 units on a scale
STANDARD_DEVIATION 6.36 • n=5 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 6.87 • n=7 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 7.53 • n=5 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 5.94 • n=4 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 6.53 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study)Population: The full analysis set (FAS) includes all randomized participants.
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Difference of percent change in EASI between current study baseline and week 36 in from parent study baseline (NCT02277743 and NCT02277769) was reported. Values after first rescue treatment used were set to missing before multiple imputation (MI).
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Difference Between Current Study Baseline and Week 36 in Percent Change in EASI From Parent Study Baseline (NCT02277743 and NCT02277769)
|
21.67 percent change
Standard Error 3.134
|
6.84 percent change
Standard Error 2.434
|
3.84 percent change
Standard Error 2.283
|
0.06 percent change
Standard Error 1.736
|
PRIMARY outcome
Timeframe: Week 36Population: FAS population was used. Here, number of participants analyzed = participants with EASI-75 at baseline.
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved \>=75% overall improvement in EASI score at Week 36. Values after first rescue treatment used were set to missing. Patients with missing value at week 36 were considered as a non-responder.
Outcome measures
| Measure |
Placebo QW
n=79 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=82 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=162 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Percentage of Participants With Eczema Area and Severity Index >= 75% [EASI-75] at Baseline of Current Study Maintaining EASI-75 at Week 36
|
30.4 percentage of participants
|
54.9 percentage of participants
|
58.3 percentage of participants
|
71.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: FAS population was used. Here, number of participants analyzed = participants with IGA 0 or 1 at Baseline from Interactive voice response system (IVRS).
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 at baseline and maintaining within 1 point of baseline were reported as responders. Values after first rescue treatment used were set to missing. Participants with missing value at a visit were considered as a non-responder.
Outcome measures
| Measure |
Placebo QW
n=63 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=64 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=66 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=126 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Response Within 1 Point of Baseline at Week 36
|
28.6 percentage of participants
|
50.0 percentage of participants
|
62.1 percentage of participants
|
70.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: FAS population was used. Here, number of participants analyzed = participants with IGA 0 or 1 at Baseline from IVRS.
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 at week 36 were reported as responders. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 36 were considered as non-responders.
Outcome measures
| Measure |
Placebo QW
n=63 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=64 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=66 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=126 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Response at 0 or 1 Point at Week 36
|
14.3 percentage of participants
|
32.8 percentage of participants
|
43.9 percentage of participants
|
54.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 35Population: FAS population was used. Here, number of participants analyzed = participants with NRS \<= 7 at Baseline.
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 35 were considered as non-responders.
Outcome measures
| Measure |
Placebo QW
n=80 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=81 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=83 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=168 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Percentage of Participants With Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score Increased by 3 or More Points From Baseline to Week 35
|
70.0 percentage of participants
|
55.6 percentage of participants
|
49.4 percentage of participants
|
33.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Population: FAS population was used. Here, number of participants analyzed = participants with IGA 0 or 1 at Baseline from IVRS.
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).
Outcome measures
| Measure |
Placebo QW
n=63 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=64 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=66 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=126 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Time to First Event of Investigator's Global Assessment (IGA) >= 2 for Participants With IGA 0 or 1 at Baseline
|
57 Days
Interval 56.0 to 58.0
|
85 Days
Interval 59.0 to 113.0
|
80 Days
Interval 55.0 to 85.0
|
114 Days
Interval 85.0 to 169.0
|
SECONDARY outcome
Timeframe: Week 36Population: FAS population was used. Here, number of participants analyzed = participants with IGA 0 or 1 at Baseline from IVRS.
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 36 were considered as responders (i.e. having a increase 3 or 4 of IGA value).
Outcome measures
| Measure |
Placebo QW
n=63 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=64 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=66 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=126 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Percentage of Participants With Increased Investigator's Global Assessment (IGA) Score 3 or 4 at Week 36
|
66.7 percentage of participants
|
48.4 percentage of participants
|
34.8 percentage of participants
|
26.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: FAS population was used.
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved \>= 50% overall improvement in EASI score from baseline to Week 36. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 36 were considered as non-responders.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (>= 50% Reduction in EASI Score) at Week 36
|
39.8 percentage of participants
|
54.8 percentage of participants
|
60.5 percentage of participants
|
73.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: FAS population was used.
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue treatment were set to missing and participants with missing Values at Week 36 were imputed by using multiple imputation method.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 36
|
6.61 units on a scale
Standard Error 0.799
|
1.75 units on a scale
Standard Error 0.738
|
1.37 units on a scale
Standard Error 0.735
|
0.09 units on a scale
Standard Error 0.511
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: FAS population was used.
SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). Values after first rescue treatment used were set to missing (censoring) before MI.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 36
|
18.61 units on a scale
Standard Error 2.107
|
6.62 units on a scale
Standard Error 2.010
|
2.25 units on a scale
Standard Error 1.899
|
0.99 units on a scale
Standard Error 1.350
|
SECONDARY outcome
Timeframe: Baseline, Week 35Population: FAS population was used.
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Values after first rescue treatment used were set to missing before MI.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score at Week 35
|
2.5 units on a scale
Standard Error 0.29
|
1.1 units on a scale
Standard Error 0.27
|
0.6 units on a scale
Standard Error 0.25
|
-0.1 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline through Week 36Population: FAS population was used.
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]). It was reported as a percentage of all major body sections combined. Values after first rescue treatment used were set to missing (censoring) before MI.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Body Surface Area (BSA) Through Week 36
|
9.16 meter square
Standard Error 1.642
|
2.74 meter square
Standard Error 1.530
|
1.74 meter square
Standard Error 1.457
|
-1.27 meter square
Standard Error 1.044
|
SECONDARY outcome
Timeframe: Baseline through Week 36Population: FAS population was used.
The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \[QOL\]). Values after first rescue treatment used were set to missing (censoring) before MI.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Absolute Change From Baseline Through in Patient Oriented Eczema Measure (POEM) Through Week 36
|
7.0 units on a scale
Standard Error 0.90
|
2.8 units on a scale
Standard Error 0.78
|
0.8 units on a scale
Standard Error 0.73
|
-0.3 units on a scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline through Week 36Population: FAS population was used.
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL. Values after first rescue treatment used were set to missing before MI.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 36
|
3.1 units on a scale
Standard Error 0.52
|
1.5 units on a scale
Standard Error 0.46
|
0.3 units on a scale
Standard Error 0.48
|
-0.2 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline through Week 36Population: FAS population was used.
HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression. Values after first rescue treatment used were set to missing before MI.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Hospital Anxiety Depression Scale (HADS) Through Week 36
|
0.8 units on a scale
Standard Error 0.60
|
0.7 units on a scale
Standard Error 0.52
|
0.2 units on a scale
Standard Error 0.54
|
-0.8 units on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study)Population: FAS population was used.
SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). Values after first rescue treatment used were set to missing before MI.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Difference Between Current Study Baseline and Week 36 in Percent Change in SCORAD From Parent Study Baseline
|
28.97 Percent change
Standard Error 3.683
|
10.42 Percent change
Standard Error 2.988
|
2.21 Percent change
Standard Error 2.743
|
0.33 Percent change
Standard Error 2.092
|
SECONDARY outcome
Timeframe: Baseline (Parent Study), Baseline (Current Study) and Week 35 (Current study)Population: FAS population was used.
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Values after first rescue treatment used were set to missing before MI.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Difference Between Current Study Baseline and Week 35 in Percent Change in Peak Weekly Pruritus NRS From Parent Study Baseline
|
35.6 percent change
Standard Error 4.32
|
16.7 percent change
Standard Error 4.09
|
8.6 percent change
Standard Error 4.02
|
-0.1 percent change
Standard Error 3.05
|
SECONDARY outcome
Timeframe: Baseline through Week 36Population: FAS population was used.
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug up to the end of study \[Week 36\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Annualized Event Rate of Skin Infection Treatment- Emergent Adverse Events (TEAEs)
|
0.12 events per year
Interval 0.044 to 0.338
|
0.07 events per year
Interval 0.024 to 0.226
|
0.02 events per year
Interval 0.005 to 0.12
|
0.02 events per year
Interval 0.007 to 0.083
|
SECONDARY outcome
Timeframe: Baseline through week 36Population: FAS population was used.
Rate of Flares defined as worsening of disease requiring initiation or escalation of rescue treatment.
Outcome measures
| Measure |
Placebo QW
n=83 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=86 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=169 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Annualized Event Rate of Flares
|
0.75 events per year
Interval 0.465 to 1.214
|
0.60 events per year
Interval 0.363 to 0.977
|
0.39 events per year
Interval 0.231 to 0.661
|
0.24 events per year
Interval 0.146 to 0.38
|
SECONDARY outcome
Timeframe: Baseline through Week 36Population: The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Here, number of participants analyzed = participants with available data for this endpoint. One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in SAF.
Well-controlled weeks are those in which participants during their weekly IVRS call completion has their eczema been well-controlled over the last week during which no rescue treatments were administered. Percentage of well-controlled weeks during the on-treatment period were reported.
Outcome measures
| Measure |
Placebo QW
n=81 Participants
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=82 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=87 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=165 Participants
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Percentage of Well-Controlled Weeks During the On-treatment Period
|
40.9 percentage of weeks
Standard Deviation 30.35
|
53.2 percentage of weeks
Standard Deviation 32.95
|
52.3 percentage of weeks
Standard Deviation 35.96
|
63.6 percentage of weeks
Standard Deviation 32.08
|
Adverse Events
Placebo QW
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Dupilumab 300 mg Q8W
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Dupilumab 300 mg Q4W
Serious events: 4 serious events
Other events: 47 other events
Deaths: 1 deaths
Dupilumab 300 mg Q2W/QW
Serious events: 6 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo QW
n=82 participants at risk
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 participants at risk
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=87 participants at risk
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=167 participants at risk
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.1%
1/87 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Cardiac disorders
Tachycardia induced cardiomyopathy
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.1%
1/87 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.60%
1/167 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.1%
1/87 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.2%
1/84 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.60%
1/167 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.2%
2/167 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
2.4%
2/84 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.1%
1/87 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.60%
1/167 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Pregnancy, puerperium and perinatal conditions
Biochemical pregnancy
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.60%
1/167 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.1%
1/87 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.2%
1/82 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.1%
1/87 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.1%
1/87 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/167 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Vascular disorders
Hypertension
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.60%
1/167 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.60%
1/167 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/87 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.60%
1/167 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
Other adverse events
| Measure |
Placebo QW
n=82 participants at risk
Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
|
Dupilumab 300 mg Q8W
n=84 participants at risk
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q4W
n=87 participants at risk
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
|
Dupilumab 300 mg Q2W/QW
n=167 participants at risk
Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
2.4%
2/82 • Number of events 22 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
3.6%
3/84 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
2.3%
2/87 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
6.0%
10/167 • Number of events 62 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Infections and infestations
Bronchitis
|
1.2%
1/82 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
5.7%
5/87 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.8%
3/167 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Infections and infestations
Influenza
|
1.2%
1/82 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
0.00%
0/84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
5.7%
5/87 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
2.4%
4/167 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Infections and infestations
Nasopharyngitis
|
13.4%
11/82 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
13.1%
11/84 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
12.6%
11/87 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
19.2%
32/167 • Number of events 41 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Infections and infestations
Oral herpes
|
3.7%
3/82 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
6.0%
5/84 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
2.3%
2/87 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
1.8%
3/167 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
6/82 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
8.3%
7/84 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
5.7%
5/87 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
7.8%
13/167 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Nervous system disorders
Headache
|
2.4%
2/82 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
3.6%
3/84 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
5.7%
5/87 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
4.8%
8/167 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
48.8%
40/82 • Number of events 60 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
32.1%
27/84 • Number of events 34 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
34.5%
30/87 • Number of events 43 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
20.4%
34/167 • Number of events 43 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
|
Additional Information
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