Trial Outcomes & Findings for Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (NCT NCT03738423)
NCT ID: NCT03738423
Last Updated: 2022-06-10
Results Overview
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, 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. Percent change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing.
TERMINATED
PHASE2
129 participants
Week 16
2022-06-10
Participant Flow
A total of 238 participants were screened at centers in North America (United States of America and Canada), Europe (Czech Republic, Germany, Hungary, Spain, and Poland), and Asia Pacific (Republic of Korea, Japan, and Australia). Out of which, 129 participants were randomized in this study.
Participants were randomized in 1:1:1:1:1 ratio to 1 of the 5 treatment groups: Placebo every 2 weeks (Q2W); REGN3500 30 milligrams (mg) every 8 weeks (Q8W); REGN3500 100 mg every 4 weeks (Q4W); REGN3500 300 mg Q4W and REGN3500 300 mg Q2W.
Participant milestones
| Measure |
Placebo Q2W
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
27
|
25
|
26
|
|
Overall Study
Treated
|
25
|
26
|
26
|
24
|
26
|
|
Overall Study
COMPLETED
|
11
|
13
|
14
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
13
|
15
|
15
|
Reasons for withdrawal
| Measure |
Placebo Q2W
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
12
|
9
|
12
|
10
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Randomized but never treated
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Here, "Number Analyzed" signifies those participants who were evaluable for this baseline characteristic.
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=25 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=26 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=27 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=25 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=26 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.6 Years
STANDARD_DEVIATION 14.22 • n=25 Participants
|
36.0 Years
STANDARD_DEVIATION 16.41 • n=26 Participants
|
37.0 Years
STANDARD_DEVIATION 14.48 • n=27 Participants
|
35.6 Years
STANDARD_DEVIATION 12.56 • n=25 Participants
|
38.8 Years
STANDARD_DEVIATION 15.44 • n=26 Participants
|
36.8 Years
STANDARD_DEVIATION 14.51 • n=129 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=25 Participants
|
13 Participants
n=26 Participants
|
12 Participants
n=27 Participants
|
14 Participants
n=25 Participants
|
15 Participants
n=26 Participants
|
68 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=25 Participants
|
13 Participants
n=26 Participants
|
15 Participants
n=27 Participants
|
11 Participants
n=25 Participants
|
11 Participants
n=26 Participants
|
61 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
7 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=25 Participants
|
24 Participants
n=26 Participants
|
22 Participants
n=27 Participants
|
25 Participants
n=25 Participants
|
23 Participants
n=26 Participants
|
118 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
3 Participants
n=26 Participants
|
4 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=25 Participants
|
8 Participants
n=26 Participants
|
5 Participants
n=27 Participants
|
11 Participants
n=25 Participants
|
10 Participants
n=26 Participants
|
43 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=25 Participants
|
4 Participants
n=26 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
14 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=25 Participants
|
14 Participants
n=26 Participants
|
20 Participants
n=27 Participants
|
11 Participants
n=25 Participants
|
14 Participants
n=26 Participants
|
72 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=129 Participants
|
|
Eczema Area and Severity Index (EASI) Score
|
30.3 Scores on a scale
STANDARD_DEVIATION 11.88 • n=25 Participants • Here, "Number Analyzed" signifies those participants who were evaluable for this baseline characteristic.
|
29.8 Scores on a scale
STANDARD_DEVIATION 12.00 • n=26 Participants • Here, "Number Analyzed" signifies those participants who were evaluable for this baseline characteristic.
|
33.6 Scores on a scale
STANDARD_DEVIATION 11.01 • n=27 Participants • Here, "Number Analyzed" signifies those participants who were evaluable for this baseline characteristic.
|
27.7 Scores on a scale
STANDARD_DEVIATION 10.68 • n=24 Participants • Here, "Number Analyzed" signifies those participants who were evaluable for this baseline characteristic.
|
32.7 Scores on a scale
STANDARD_DEVIATION 15.13 • n=26 Participants • Here, "Number Analyzed" signifies those participants who were evaluable for this baseline characteristic.
|
30.9 Scores on a scale
STANDARD_DEVIATION 12.25 • n=128 Participants • Here, "Number Analyzed" signifies those participants who were evaluable for this baseline characteristic.
|
PRIMARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, 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. Percent change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing.
Outcome measures
| Measure |
Placebo Q2W
n=10 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
-33.5 Percentage of change
Standard Deviation 41.81
|
-57.9 Percentage of change
Standard Deviation 31.65
|
-52.7 Percentage of change
Standard Deviation 46.64
|
-80.0 Percentage of change
Standard Deviation 10.54
|
-54.0 Percentage of change
Standard Deviation 36.80
|
PRIMARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, induration, 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. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.
Outcome measures
| Measure |
Placebo Q2W
n=12 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=10 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
-18.9 Percentage of change
Standard Deviation 52.01
|
-46.0 Percentage of change
Standard Deviation 45.35
|
-48.7 Percentage of change
Standard Deviation 44.66
|
-67.0 Percentage of change
Standard Deviation 28.74
|
-56.1 Percentage of change
Standard Deviation 35.32
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
Outcome measures
| Measure |
Placebo Q2W
n=10 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
30.0 Percentage of participants
|
71.4 Percentage of participants
|
71.4 Percentage of participants
|
100 Percentage of participants
|
55.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported.
Outcome measures
| Measure |
Placebo Q2W
n=12 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=10 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
25.0 Percentage of participants
|
60.0 Percentage of participants
|
62.5 Percentage of participants
|
77.8 Percentage of participants
|
60.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
Outcome measures
| Measure |
Placebo Q2W
n=10 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
20.0 Percentage of participants
|
28.6 Percentage of participants
|
28.6 Percentage of participants
|
71.4 Percentage of participants
|
44.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.
Outcome measures
| Measure |
Placebo Q2W
n=12 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=10 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
16.7 Percentage of participants
|
30.0 Percentage of participants
|
25.0 Percentage of participants
|
55.6 Percentage of participants
|
40.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
Outcome measures
| Measure |
Placebo Q2W
n=10 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
10.0 Percentage of participants
|
14.3 Percentage of participants
|
28.6 Percentage of participants
|
28.6 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.
Outcome measures
| Measure |
Placebo Q2W
n=12 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=10 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
8.3 Percentage of participants
|
20.0 Percentage of participants
|
25.0 Percentage of participants
|
22.2 Percentage of participants
|
30.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, induration, 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. Absolute change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported.
Outcome measures
| Measure |
Placebo Q2W
n=10 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
-7.8 Score on a scale
Standard Deviation 10.225
|
-14.64 Score on a scale
Standard Deviation 8.489
|
-14.81 Score on a scale
Standard Deviation 12.614
|
-18.19 Score on a scale
Standard Deviation 6.298
|
-13.79 Score on a scale
Standard Deviation 9.534
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
The EASI score was used to measure the severity and extent of AD and measures erythema, induration, 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. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.
Outcome measures
| Measure |
Placebo Q2W
n=12 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=10 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
-4.10 Score on a scale
Standard Deviation 13.079
|
-12.07 Score on a scale
Standard Deviation 11.764
|
-13.83 Score on a scale
Standard Deviation 12.000
|
-15.15 Score on a scale
Standard Deviation 8.299
|
-14.68 Score on a scale
Standard Deviation 9.410
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
IGA was 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 was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing IGA score at Week 16 were counted as non-responders.
Outcome measures
| Measure |
Placebo Q2W
n=10 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
28.6 Percentage of participants
|
42.9 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
IGA was 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 was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported.
Outcome measures
| Measure |
Placebo Q2W
n=12 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=10 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
8.3 Percentage of participants
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
33.3 Percentage of participants
|
30.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported.
Outcome measures
| Measure |
Placebo Q2W
n=9 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=8 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
-0.53 Score on a scale
Standard Deviation 1.583
|
-2.95 Score on a scale
Standard Deviation 3.791
|
-4.22 Score on a scale
Standard Deviation 2.372
|
-3.34 Score on a scale
Standard Deviation 2.628
|
-3.12 Score on a scale
Standard Deviation 3.896
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
Outcome measures
| Measure |
Placebo Q2W
n=11 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=8 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
-0.51 Score on a scale
Standard Deviation 1.430
|
-2.56 Score on a scale
Standard Deviation 3.563
|
-4.19 Score on a scale
Standard Deviation 2.198
|
-2.69 Score on a scale
Standard Deviation 2.799
|
-3.12 Score on a scale
Standard Deviation 3.896
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.
Outcome measures
| Measure |
Placebo Q2W
n=9 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=8 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
-6.1 Percentage of change
Standard Deviation 20.65
|
-31.6 Percentage of change
Standard Deviation 39.01
|
-53.1 Percentage of change
Standard Deviation 29.65
|
-43.1 Percentage of change
Standard Deviation 36.42
|
-32.2 Percentage of change
Standard Deviation 47.46
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported.
Outcome measures
| Measure |
Placebo Q2W
n=11 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=8 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
-5.9 Percentage of change
Standard Deviation 18.62
|
-27.5 Percentage of change
Standard Deviation 39.24
|
-52.8 Percentage of change
Standard Deviation 27.47
|
-33.9 Percentage of change
Standard Deviation 38.71
|
-32.2 Percentage of change
Standard Deviation 47.46
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.
Outcome measures
| Measure |
Placebo Q2W
n=9 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=7 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=7 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=7 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=8 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16
|
0.0 Percentage of participants
|
42.9 Percentage of participants
|
57.1 Percentage of participants
|
28.6 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on all observed values regardless of rescue treatment were reported.
Outcome measures
| Measure |
Placebo Q2W
n=11 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=8 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16
|
0.0 Percentage of participants
|
40.0 Percentage of participants
|
62.5 Percentage of participants
|
22.2 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Time to event analysis performed for participants in FAS with baseline weekly peak NRS score ≥4 and at least one post-baseline weekly peak NRS score reduced ≥4 points from baseline. Time to event was calculated in weeks as the (date of first event - the date of first dose)/7. The event of NRS reduction ≥4 was based on observed data regardless of rescue use. Here 'n' = number of evaluable participants analyzed at specified time frame.
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
Outcome measures
| Measure |
Placebo Q2W
n=5 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=6 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=6 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=4 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline)
|
6.6 Weeks
Standard Deviation 3.71
|
7.1 Weeks
Standard Deviation 4.74
|
7.1 Weeks
Standard Deviation 5.02
|
6.0 Weeks
Standard Deviation 4.29
|
5.8 Weeks
Standard Deviation 3.50
|
SECONDARY outcome
Timeframe: Week 16Population: FAS; All observed values, regardless of rescue treatment use; Here 'n' = number of evaluable participants at the specific timepoint
The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Outcome measures
| Measure |
Placebo Q2W
n=12 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=10 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16
|
-12.7 Percentage of change
Standard Deviation 25.41
|
-31.4 Percentage of change
Standard Deviation 22.67
|
-39.2 Percentage of change
Standard Deviation 38.39
|
-42.40 Percentage of change
Standard Deviation 20.00
|
-40.5 Percentage of change
Standard Deviation 29.00
|
SECONDARY outcome
Timeframe: Week 16Population: FAS; All observed values regardless of rescue treatment use; Here 'n' = number of evaluable participants at the specific timepoint
BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]) and will be reported as a percentage of all major body sections combined. The proportion assigned to different body regions is different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children).
Outcome measures
| Measure |
Placebo Q2W
n=12 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=10 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=8 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=9 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=10 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16
|
-2.74 Percentage of change
Standard Deviation 17.854
|
-15.19 Percentage of change
Standard Deviation 16.509
|
-11.43 Percentage of change
Standard Deviation 22.022
|
-22.16 Percentage of change
Standard Deviation 15.783
|
-20.99 Percentage of change
Standard Deviation 16.161
|
SECONDARY outcome
Timeframe: Up to week 16Population: The safety analysis set (SAF) included all randomized participants who received any study drug and was based on the treatment received (as treated).
Adverse Event (AE): any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE): any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included: serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported.
Outcome measures
| Measure |
Placebo Q2W
n=25 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=26 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=26 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=24 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=26 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16
Participants with TEAEs
|
9 Participants
|
13 Participants
|
12 Participants
|
9 Participants
|
15 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16
Participants with Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16
Participants with AESIs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to week 36Population: SAF included all randomized participants who received any study drug and was based on the treatment received (as treated).
AE: any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. SAE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included both Serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported.
Outcome measures
| Measure |
Placebo Q2W
n=25 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=26 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=26 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=24 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=26 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36
Participants with TEAEs
|
11 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
15 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36
Participants with Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36
Participants with AESIs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36Population: The Pharmacokinetic (PK) analysis set included all randomized participants who received any study drug and who had at least 1 non-missing study drug concentration result following the first dose of study drug. Here, "Number Analyzed" signifies those participants who were evaluable at given time points.
Serum Concentration of Functional REGN3500 was reported.
Outcome measures
| Measure |
Placebo Q2W
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=26 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=26 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=24 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=26 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Serum Concentration of Functional REGN3500
Baseline (Week 0)
|
—
|
NA Milligrams per Liter (mg/L)
Standard Deviation NA
Data were below the level of quantitation
|
0.157 Milligrams per Liter (mg/L)
Standard Deviation 0.800
|
NA Milligrams per Liter (mg/L)
Standard Deviation NA
Data were below the level of quantitation
|
NA Milligrams per Liter (mg/L)
Standard Deviation NA
Data were below the level of quantitation
|
|
Serum Concentration of Functional REGN3500
Week 2
|
—
|
3.29 Milligrams per Liter (mg/L)
Standard Deviation 2.70
|
7.35 Milligrams per Liter (mg/L)
Standard Deviation 5.65
|
21.4 Milligrams per Liter (mg/L)
Standard Deviation 9.83
|
22.0 Milligrams per Liter (mg/L)
Standard Deviation 11.0
|
|
Serum Concentration of Functional REGN3500
Week 4
|
—
|
2.33 Milligrams per Liter (mg/L)
Standard Deviation 1.82
|
5.14 Milligrams per Liter (mg/L)
Standard Deviation 3.73
|
14.3 Milligrams per Liter (mg/L)
Standard Deviation 7.05
|
37.9 Milligrams per Liter (mg/L)
Standard Deviation 15.2
|
|
Serum Concentration of Functional REGN3500
Week 8
|
—
|
1.41 Milligrams per Liter (mg/L)
Standard Deviation 1.99
|
9.27 Milligrams per Liter (mg/L)
Standard Deviation 5.33
|
23.3 Milligrams per Liter (mg/L)
Standard Deviation 10.4
|
51.4 Milligrams per Liter (mg/L)
Standard Deviation 20.7
|
|
Serum Concentration of Functional REGN3500
Week 12
|
—
|
2.63 Milligrams per Liter (mg/L)
Standard Deviation 2.20
|
8.74 Milligrams per Liter (mg/L)
Standard Deviation 6.37
|
30.3 Milligrams per Liter (mg/L)
Standard Deviation 12.0
|
57.7 Milligrams per Liter (mg/L)
Standard Deviation 26.3
|
|
Serum Concentration of Functional REGN3500
Week 16
|
—
|
1.05 Milligrams per Liter (mg/L)
Standard Deviation 0.733
|
10.6 Milligrams per Liter (mg/L)
Standard Deviation 4.91
|
35.2 Milligrams per Liter (mg/L)
Standard Deviation 17.3
|
60.8 Milligrams per Liter (mg/L)
Standard Deviation 33.3
|
|
Serum Concentration of Functional REGN3500
Week 20
|
—
|
0.523 Milligrams per Liter (mg/L)
Standard Deviation 0.441
|
5.03 Milligrams per Liter (mg/L)
Standard Deviation 3.93
|
12.4 Milligrams per Liter (mg/L)
Standard Deviation 6.58
|
29.8 Milligrams per Liter (mg/L)
Standard Deviation 23.5
|
|
Serum Concentration of Functional REGN3500
Week 24
|
—
|
0.170 Milligrams per Liter (mg/L)
Standard Deviation 0.157
|
2.23 Milligrams per Liter (mg/L)
Standard Deviation 1.24
|
7.14 Milligrams per Liter (mg/L)
Standard Deviation 5.22
|
12.1 Milligrams per Liter (mg/L)
Standard Deviation 14.4
|
|
Serum Concentration of Functional REGN3500
Week 28
|
—
|
0.0838 Milligrams per Liter (mg/L)
Standard Deviation 0.109
|
1.08 Milligrams per Liter (mg/L)
Standard Deviation 0.813
|
3.49 Milligrams per Liter (mg/L)
Standard Deviation 2.76
|
6.70 Milligrams per Liter (mg/L)
Standard Deviation 7.64
|
|
Serum Concentration of Functional REGN3500
Week 32
|
—
|
0.0171 Milligrams per Liter (mg/L)
Standard Deviation 0.0484
|
0.625 Milligrams per Liter (mg/L)
Standard Deviation 0.560
|
1.93 Milligrams per Liter (mg/L)
Standard Deviation 1.37
|
3.73 Milligrams per Liter (mg/L)
Standard Deviation 5.41
|
|
Serum Concentration of Functional REGN3500
Week 36
|
—
|
NA Milligrams per Liter (mg/L)
Standard Deviation NA
Data were below the level of quantitation
|
0.299 Milligrams per Liter (mg/L)
Standard Deviation 0.250
|
0.960 Milligrams per Liter (mg/L)
Standard Deviation 0.741
|
1.02 Milligrams per Liter (mg/L)
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Up to week 36Population: The Anti-drug Antibodies (ADA) analysis set included all treated participants who received any amount of study drug (active or placebo \[safety analysis set\]) and had at least one non-missing anti-REGN3500 result following the first dose of study drug or placebo.
Treatment-Emergent (TE) ADA was defined as any positive post baseline assay response when baseline results were negative or missing. Treatment-Emergent ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period \[based on nominal sampling time\], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). Number of participants with positive treatment-emergent anti-REGN3500 antibodies (ADA) were reported. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint.
Outcome measures
| Measure |
Placebo Q2W
n=24 Participants
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 30 mg Q8W
n=25 Participants
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
REGN3500 100 mg Q4W
n=25 Participants
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q4W
n=22 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
REGN3500 300 mg Q2W
n=24 Participants
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA)
TE Persistent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA)
TE Transient
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA)
TE Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo Q2W
R3500 30 mg Q8W
R3500 100 mg Q4W
R3500 300 mg Q4W
R3500 300 mg Q2W
Serious adverse events
| Measure |
Placebo Q2W
n=25 participants at risk
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
R3500 30 mg Q8W
n=26 participants at risk
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
R3500 100 mg Q4W
n=26 participants at risk
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
R3500 300 mg Q4W
n=24 participants at risk
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
R3500 300 mg Q2W
n=26 participants at risk
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
3.8%
1/26 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
3.8%
1/26 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
4.2%
1/24 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
Other adverse events
| Measure |
Placebo Q2W
n=25 participants at risk
Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
R3500 30 mg Q8W
n=26 participants at risk
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
|
R3500 100 mg Q4W
n=26 participants at risk
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
R3500 300 mg Q4W
n=24 participants at risk
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
|
R3500 300 mg Q2W
n=26 participants at risk
Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
7.7%
2/26 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
15.4%
4/26 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
8.3%
2/24 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
11.5%
3/26 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
7.7%
2/26 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
3.8%
1/26 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
8.3%
2/24 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
3.8%
1/26 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
4.2%
1/24 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
12.0%
3/25 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
30.8%
8/26 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
19.2%
5/26 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
20.8%
5/24 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
23.1%
6/26 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Gastrointestinal disorders
Toothache
|
4.0%
1/25 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
3.8%
1/26 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
7.7%
2/26 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
8.3%
2/24 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
3.8%
1/26 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
7.7%
2/26 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
|
General disorders
Oedema peripheral
|
0.00%
0/25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
7.7%
2/26 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
0.00%
0/24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
3.8%
1/26 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER