Trial Outcomes & Findings for Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis (NCT NCT04212169)
NCT ID: NCT04212169
Last Updated: 2023-09-28
Results Overview
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
148 participants
Primary outcome timeframe
Week 16
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Placebo
Pooled Placebo
|
MEDI3506 Dose 1
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
19
|
18
|
55
|
|
Overall Study
COMPLETED
|
42
|
16
|
13
|
42
|
|
Overall Study
NOT COMPLETED
|
14
|
3
|
5
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Pooled Placebo
|
MEDI3506 Dose 1
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
2
|
5
|
7
|
|
Overall Study
Other reason, unspecified
|
3
|
1
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=56 Participants
Pooled Placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.3 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
28.7 Years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
37.9 Years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
34.6 Years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
33.4 Years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE CATEGORIES CHECKED
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
46 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Region of Enrollment
USA
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
34 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Eczema Area and Severity Index (EASI) score
|
28.81 Scores on a scale
STANDARD_DEVIATION 8.90 • n=5 Participants
|
28.94 Scores on a scale
STANDARD_DEVIATION 11.66 • n=7 Participants
|
28.36 Scores on a scale
STANDARD_DEVIATION 11.87 • n=5 Participants
|
32.30 Scores on a scale
STANDARD_DEVIATION 10.86 • n=4 Participants
|
30.07 Scores on a scale
STANDARD_DEVIATION 10.43 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population. Data after study withdrawal or use of rescue therapy was excluded.
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
Outcome measures
| Measure |
Placebo
n=55 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=17 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=54 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 16 in EASI Score
Percent change from baseline to Week 16 in EASI score analysed using MCP-mod dose response model
|
NA Percentage of change from baseline
Standard Error NA
No dose response model selected from the MCP-mod analysis because the dose response was absent
|
NA Percentage of change from baseline
Standard Error NA
No dose response model selected from the MCP-mod analysis because the dose response was absent
|
NA Percentage of change from baseline
Standard Error NA
No dose response model selected from the MCP-mod analysis because the dose response was absent
|
NA Percentage of change from baseline
Standard Error NA
No dose response model selected from the MCP-mod analysis because the dose response was absent
|
|
Percent Change From Baseline to Week 16 in EASI Score
Percent change from baseline to Week 16 in EASI score analysed using a repeated measures mixed model
|
-51.31 Percentage of change from baseline
Standard Error 5.214
|
-50.03 Percentage of change from baseline
Standard Error 7.419
|
-45.43 Percentage of change from baseline
Standard Error 8.402
|
-53.02 Percentage of change from baseline
Standard Error 4.858
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
|
4 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
|
12 Participants
|
5 Participants
|
5 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population. Subjects who discontinued IP, withdrew from the study, or required rescue therapy were considered as non responders.
The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
IGA response rate at Week 16
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
IGA response rate at Week 16 using MCP-Mod dose-response analysis
|
NA Participants
No dose response model was selected from MCP-mod analysis due to logistic regression not converging
|
NA Participants
No dose response model was selected from MCP-mod analysis due to logistic regression not converging
|
NA Participants
No dose response model was selected from MCP-mod analysis due to logistic regression not converging
|
NA Participants
No dose response model was selected from MCP-mod analysis due to logistic regression not converging
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population. Subjects who withdrew from the study or required rescue therapy considered as non-responders.
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
|
9 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population, excluding missing data at baseline or week 16.
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Outcome measures
| Measure |
Placebo
n=55 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
|
-1.41 Scores on a scale
Standard Deviation 0.356
|
-1.06 Scores on a scale
Standard Deviation 0.519
|
-2.01 Scores on a scale
Standard Deviation 0.595
|
-2.24 Scores on a scale
Standard Deviation 0.348
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population, excluding missing data at baseline or week 16.
Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.
Outcome measures
| Measure |
Placebo
n=41 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=16 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=12 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=40 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
|
-1.44 Scores on a scale
Standard Deviation 2.39
|
-1.66 Scores on a scale
Standard Deviation 2.62
|
-1.52 Scores on a scale
Standard Deviation 1.61
|
-1.63 Scores on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population, excluding missing data at baseline or week 16.
SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=35 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=15 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=12 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=40 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
SCORAD: Percent Change From Baseline to Week 16
|
-31.79 Percentage of change from baseline
Standard Deviation 25.09
|
-29.88 Percentage of change from baseline
Standard Deviation 23.14
|
-36.22 Percentage of change from baseline
Standard Deviation 25.34
|
-39.42 Percentage of change from baseline
Standard Deviation 25.44
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population, excluding missing data at baseline or week 16.
Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.
Outcome measures
| Measure |
Placebo
n=37 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=15 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=13 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=40 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
|
-17.81 Percentage of body surface area
Standard Deviation 17.09
|
-11.07 Percentage of body surface area
Standard Deviation 10.92
|
-9.46 Percentage of body surface area
Standard Deviation 13.23
|
-23.13 Percentage of body surface area
Standard Deviation 19.35
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population, excluding missing data at baseline or week 16.
The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life.
Outcome measures
| Measure |
Placebo
n=38 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=15 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=12 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=40 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 16 in DLQI
|
-2.9 Scores on scale
Standard Deviation 5.3
|
-2.1 Scores on scale
Standard Deviation 6.5
|
-2.4 Scores on scale
Standard Deviation 4.9
|
-2.7 Scores on scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of "No symptoms", "Very mild", "Mild", "Moderate", "Severe" and "Very severe".
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Severe
|
11 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
No symptoms
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Very mild
|
5 Participants
|
0 Participants
|
5 Participants
|
10 Participants
|
|
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Mild
|
9 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
|
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Moderate
|
11 Participants
|
5 Participants
|
1 Participants
|
14 Participants
|
|
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Very severe
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Missing data
|
18 Participants
|
4 Participants
|
6 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population, excluding missing data at baseline or week 16.
The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease
Outcome measures
| Measure |
Placebo
n=38 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=15 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=12 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=40 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 16 in POEM
|
-5.4 Scores on scale
Standard Deviation 7.9
|
-2.5 Scores on scale
Standard Deviation 4.8
|
-3.7 Scores on scale
Standard Deviation 8.7
|
-6.3 Scores on scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population, excluding missing data at baseline or week 16.
The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome
Outcome measures
| Measure |
Placebo
n=38 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=15 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=12 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=40 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 16 in 5-D Itch
|
-3.0 Scores on scale
Standard Deviation 4.9
|
-3.0 Scores on scale
Standard Deviation 2.6
|
-3.8 Scores on scale
Standard Deviation 3.4
|
-4.0 Scores on scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: As-treated population
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Occurrence of Adverse Events
At least one investigational product related event
|
7 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
|
Occurrence of Adverse Events
At least one adverse event
|
37 Participants
|
9 Participants
|
14 Participants
|
32 Participants
|
|
Occurrence of Adverse Events
At least one event of ≥ grade 3 severity
|
7 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Occurrence of Adverse Events
At least one serious event
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Occurrence of Adverse Events
At least one investigational product related serious event
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 16 and week 24Population: As-treated population
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Baseline
|
36.46 degrees C
Standard Deviation 0.35
|
36.43 degrees C
Standard Deviation 0.52
|
36.41 degrees C
Standard Deviation 0.43
|
36.52 degrees C
Standard Deviation 0.39
|
|
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Week 16
|
36.49 degrees C
Standard Deviation 0.36
|
36.71 degrees C
Standard Deviation 0.41
|
36.50 degrees C
Standard Deviation 0.32
|
36.47 degrees C
Standard Deviation 0.39
|
|
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Week 24
|
36.44 degrees C
Standard Deviation 0.43
|
36.63 degrees C
Standard Deviation 0.50
|
36.55 degrees C
Standard Deviation 0.42
|
36.51 degrees C
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Baseline, week 16 and week 24Population: As-treated population
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Systolic Blood Pressure Taken During Vital Signs Assessment
Baseline
|
117.7 mmHg
Standard Deviation 12.9
|
119.3 mmHg
Standard Deviation 9.2
|
123.8 mmHg
Standard Deviation 9.9
|
121.5 mmHg
Standard Deviation 12.5
|
|
Systolic Blood Pressure Taken During Vital Signs Assessment
Week 16
|
117.8 mmHg
Standard Deviation 9.6
|
117.3 mmHg
Standard Deviation 7.2
|
120.7 mmHg
Standard Deviation 13.6
|
119.8 mmHg
Standard Deviation 10.6
|
|
Systolic Blood Pressure Taken During Vital Signs Assessment
Week 24
|
118.9 mmHg
Standard Deviation 11.1
|
117.6 mmHg
Standard Deviation 11.4
|
120.1 mmHg
Standard Deviation 15.1
|
120.6 mmHg
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline, week 16 and week 24Population: As-treated population
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Heart Rate Taken During Vital Signs Assessment
Baseline
|
68.1 Pulse Rate (beats/min)
Standard Deviation 9.8
|
66.6 Pulse Rate (beats/min)
Standard Deviation 8.7
|
71.3 Pulse Rate (beats/min)
Standard Deviation 9.3
|
68.2 Pulse Rate (beats/min)
Standard Deviation 11.1
|
|
Heart Rate Taken During Vital Signs Assessment
Week 16
|
69.4 Pulse Rate (beats/min)
Standard Deviation 10.1
|
66.9 Pulse Rate (beats/min)
Standard Deviation 10.6
|
65.9 Pulse Rate (beats/min)
Standard Deviation 8.6
|
66.4 Pulse Rate (beats/min)
Standard Deviation 11.0
|
|
Heart Rate Taken During Vital Signs Assessment
Week 24
|
72.0 Pulse Rate (beats/min)
Standard Deviation 13.5
|
67.0 Pulse Rate (beats/min)
Standard Deviation 10.4
|
74.1 Pulse Rate (beats/min)
Standard Deviation 8.7
|
67.6 Pulse Rate (beats/min)
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline, week 16 and week 24Population: As-treated population
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Respiratory Rate Collected During Vital Signs Assessment
Baseline
|
15.4 breaths/min
Standard Deviation 2.2
|
16.0 breaths/min
Standard Deviation 1.5
|
16.2 breaths/min
Standard Deviation 1.8
|
15.5 breaths/min
Standard Deviation 1.8
|
|
Respiratory Rate Collected During Vital Signs Assessment
Week 16
|
16.0 breaths/min
Standard Deviation 2.3
|
15.7 breaths/min
Standard Deviation 1.8
|
16.3 breaths/min
Standard Deviation 1.9
|
15.9 breaths/min
Standard Deviation 1.4
|
|
Respiratory Rate Collected During Vital Signs Assessment
Week 24
|
15.8 breaths/min
Standard Deviation 2.4
|
16.1 breaths/min
Standard Deviation 1.5
|
17.1 breaths/min
Standard Deviation 2.4
|
15.6 breaths/min
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: As-treated population
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Basophils · At Least One Post-Baseline Value Above ULN
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Basophils · Values within normal range
|
53 Participants
|
19 Participants
|
18 Participants
|
55 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Haemoglobin · At Least One Post-Baseline Value Above ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Basophils · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Eosinophils · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Eosinophils · At Least One Post-Baseline Value Above ULN
|
22 Participants
|
4 Participants
|
5 Participants
|
14 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Eosinophils · Values within normal range
|
34 Participants
|
15 Participants
|
13 Participants
|
41 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Hematocrit · At Least One Post-Baseline Value Below LLN
|
4 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Hematocrit · At Least One Post-Baseline Value Above ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Hematocrit · Values within normal range
|
52 Participants
|
16 Participants
|
15 Participants
|
48 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Haemoglobin · At Least One Post-Baseline Value Below LLN
|
5 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Haemoglobin · Values within normal range
|
51 Participants
|
18 Participants
|
14 Participants
|
47 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Lymphocytes · At Least One Post-Baseline Value Below LLN
|
6 Participants
|
0 Participants
|
3 Participants
|
10 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Lymphocytes · At Least One Post-Baseline Value Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Lymphocytes · Values within normal range
|
50 Participants
|
19 Participants
|
15 Participants
|
45 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Monocytes · At Least One Post-Baseline Value Below LLN
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Monocytes · At Least One Post-Baseline Value Above ULN
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Monocytes · Values within normal range
|
53 Participants
|
19 Participants
|
15 Participants
|
49 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Platelet count · At Least One Post-Baseline Value Below LLN
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Platelet count · At Least One Post-Baseline Value Above ULN
|
3 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Platelet count · Values within normal range
|
52 Participants
|
18 Participants
|
16 Participants
|
50 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Erythrocytes · At Least One Post-Baseline Value Below LLN
|
10 Participants
|
3 Participants
|
4 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Erythrocytes · At Least One Post-Baseline Value Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Erythrocytes · Values within normal range
|
46 Participants
|
16 Participants
|
14 Participants
|
38 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
White blood cell count · At Least One Post-Baseline Value Below LLN
|
7 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
White blood cell count · At Least One Post-Baseline Value Above ULN
|
5 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
White blood cell count · Values within normal range
|
44 Participants
|
16 Participants
|
16 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: As-treated population
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Albumin · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Albumin · At Least One Post-Baseline Value Above ULN
|
21 Participants
|
5 Participants
|
6 Participants
|
15 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Albumin · Values within normal range
|
35 Participants
|
14 Participants
|
12 Participants
|
40 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Alkaline Phosphatase · At Least One Post-Baseline Value Below LLN
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Alkaline Phosphatase · At Least One Post-Baseline Value Above ULN
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Alkaline Phosphatase · Values within normal range
|
50 Participants
|
17 Participants
|
16 Participants
|
49 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Alanine Aminotransferase · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Alanine Aminotransferase · At Least One Post-Baseline Value Above ULN
|
7 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Alanine Aminotransferase · Values within normal range
|
49 Participants
|
15 Participants
|
14 Participants
|
50 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Aspartate Aminotransferase · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Aspartate Aminotransferase · At Least One Post-Baseline Value Above ULN
|
6 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Aspartate Aminotransferase · Values within normal range
|
50 Participants
|
16 Participants
|
15 Participants
|
47 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Bilirubin · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Bilirubin · At Least One Post-Baseline Value Above ULN
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Bilirubin · Values within normal range
|
53 Participants
|
19 Participants
|
17 Participants
|
54 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Urea Nitrogen · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Urea Nitrogen · At Least One Post-Baseline Value Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Urea Nitrogen · Values within normal range
|
56 Participants
|
19 Participants
|
18 Participants
|
53 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Creatinine · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Creatinine · At Least One Post-Baseline Value Above ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Creatinine · Values within normal range
|
56 Participants
|
19 Participants
|
17 Participants
|
52 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Gamma Glutamyl Transferase · At Least One Post-Baseline Value Below LLN
|
4 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Gamma Glutamyl Transferase · At Least One Post-Baseline Value Above ULN
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Gamma Glutamyl Transferase · Values within normal range
|
50 Participants
|
14 Participants
|
16 Participants
|
49 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Potassium · At Least One Post-Baseline Value Below LLN
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Potassium · At Least One Post-Baseline Value Above ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Potassium · Values within normal range
|
54 Participants
|
18 Participants
|
17 Participants
|
53 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Sodium · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Sodium · At Least One Post-Baseline Value Above ULN
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Sodium · Values within normal range
|
54 Participants
|
19 Participants
|
18 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: As-treated population
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
pH · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
pH · At Least One Post-Baseline Value Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
pH · Values within normal range
|
56 Participants
|
19 Participants
|
18 Participants
|
54 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Erythrocytes · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Erythrocytes · At Least One Post-Baseline Value Above ULN
|
8 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Erythrocytes · Values within normal range
|
48 Participants
|
17 Participants
|
17 Participants
|
49 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Specific gravity · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Specific gravity · At Least One Post-Baseline Value Above ULN
|
4 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Specific gravity · Values within normal range
|
52 Participants
|
19 Participants
|
15 Participants
|
48 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Leukocytes · At Least One Post-Baseline Value Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Leukocytes · At Least One Post-Baseline Value Above ULN
|
4 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Leukocytes · Values within normal range
|
52 Participants
|
17 Participants
|
17 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 16 and week 24Population: As-treated population
Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Heart Rate (Beats/Min) Recorded on ECGs
Baseline
|
67.59 beats per minute
Standard Deviation 9.82
|
65.61 beats per minute
Standard Deviation 6.87
|
72.63 beats per minute
Standard Deviation 9.82
|
65.18 beats per minute
Standard Deviation 9.43
|
|
Heart Rate (Beats/Min) Recorded on ECGs
Week 16
|
66.02 beats per minute
Standard Deviation 9.97
|
63.80 beats per minute
Standard Deviation 8.56
|
65.42 beats per minute
Standard Deviation 9.08
|
63.05 beats per minute
Standard Deviation 10.61
|
|
Heart Rate (Beats/Min) Recorded on ECGs
Week 24
|
68.17 beats per minute
Standard Deviation 13.94
|
63.88 beats per minute
Standard Deviation 10.41
|
72.46 beats per minute
Standard Deviation 9.12
|
64.58 beats per minute
Standard Deviation 9.43
|
SECONDARY outcome
Timeframe: Baseline, week 16 and week 24Population: As-treated population
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
QT (Miliseconds) Recorded on ECGs
Baseline
|
385.43 milliseconds
Standard Deviation 27.75
|
390.67 milliseconds
Standard Deviation 20.57
|
380.04 milliseconds
Standard Deviation 26.38
|
390.27 milliseconds
Standard Deviation 22.69
|
|
QT (Miliseconds) Recorded on ECGs
Week 16
|
387.05 milliseconds
Standard Deviation 26.14
|
390.40 milliseconds
Standard Deviation 24.24
|
395.75 milliseconds
Standard Deviation 20.36
|
391.95 milliseconds
Standard Deviation 29.22
|
|
QT (Miliseconds) Recorded on ECGs
Week 24
|
385.88 milliseconds
Standard Deviation 34.31
|
398.69 milliseconds
Standard Deviation 28.52
|
383.15 milliseconds
Standard Deviation 19.05
|
393.40 milliseconds
Standard Deviation 26.54
|
SECONDARY outcome
Timeframe: Week 16 and week 24Population: As-treated population
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Week 24 · Missing
|
14 Participants
|
3 Participants
|
5 Participants
|
15 Participants
|
|
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Week 16 · Missing
|
15 Participants
|
4 Participants
|
6 Participants
|
13 Participants
|
|
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Week 24 · Normal ECG
|
38 Participants
|
12 Participants
|
11 Participants
|
29 Participants
|
|
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Week 24 · Abnormal ECG: Clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Week 24 · Abnormal ECG: Not Clinically significant
|
4 Participants
|
4 Participants
|
2 Participants
|
11 Participants
|
|
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Week 16 · Abnormal ECG: Clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Week 16 · Abnormal ECG: Not Clinically significant
|
3 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
|
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Week 16 · Normal ECG
|
38 Participants
|
13 Participants
|
10 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: As-treated population
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Left Ventricular Ejection Fraction Measured by Echocardiogram
Baseline
|
64.3 % LVEF
Standard Deviation 6.3
|
64.7 % LVEF
Standard Deviation 6.2
|
62.8 % LVEF
Standard Deviation 5.2
|
63.6 % LVEF
Standard Deviation 4.7
|
|
Left Ventricular Ejection Fraction Measured by Echocardiogram
Week 16
|
64.3 % LVEF
Standard Deviation 5.9
|
63.0 % LVEF
Standard Deviation 4.4
|
61.0 % LVEF
Standard Deviation 3.6
|
65.2 % LVEF
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Week 16 and week 24Population: PK population
To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=18 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=17 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=48 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Serum MEDI3506 Concentration Profiles
Week 16
|
0.377 μg/mL
Geometric Coefficient of Variation 242
|
2.158 μg/mL
Geometric Coefficient of Variation 193
|
5.979 μg/mL
Geometric Coefficient of Variation 118
|
—
|
|
Serum MEDI3506 Concentration Profiles
Week 24
|
0.018 μg/mL
Geometric Coefficient of Variation 184
|
0.118 μg/mL
Geometric Coefficient of Variation 298
|
0.188 μg/mL
Geometric Coefficient of Variation 234
|
—
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: As-treated population
To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Pooled placebo
|
MEDI3506 Dose 1
n=19 Participants
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 Participants
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 Participants
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
Baseline ADA result
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
Post-baseline ADA result
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
MEDI3506 Dose 1
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
MEDI3506 Dose 2
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
MEDI3506 Dose 3
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=56 participants at risk
Pooled Placebo
|
MEDI3506 Dose 1
n=19 participants at risk
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 participants at risk
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 participants at risk
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
Immune system disorders
Food allergy
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
Other adverse events
| Measure |
Placebo
n=56 participants at risk
Pooled Placebo
|
MEDI3506 Dose 1
n=19 participants at risk
MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 2
n=18 participants at risk
MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
|
MEDI3506 Dose 3
n=55 participants at risk
MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
|
|---|---|---|---|---|
|
General disorders
Injection site bruising
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
7.3%
4/55 • Number of events 6 • 24 weeks
|
|
General disorders
Injection site swelling
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Covid-19
|
12.5%
7/56 • Number of events 7 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
3.6%
2/55 • Number of events 2 • 24 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 2 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Conjunctivitis
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Eczema infected
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
11.1%
2/18 • Number of events 2 • 24 weeks
|
5.5%
3/55 • Number of events 3 • 24 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
5.6%
1/18 • Number of events 2 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Infections and infestations
Otitis externa
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
5.4%
3/56 • Number of events 3 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Investigations
Liver function test increased
|
3.6%
2/56 • Number of events 2 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Investigations
Urine analysis abnormal
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
11.1%
2/18 • Number of events 3 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Nervous system disorders
Headache
|
5.4%
3/56 • Number of events 3 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
5.4%
3/56 • Number of events 3 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
21.4%
12/56 • Number of events 14 • 24 weeks
|
10.5%
2/19 • Number of events 2 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
25.5%
14/55 • Number of events 17 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.4%
3/56 • Number of events 3 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
11.1%
2/18 • Number of events 2 • 24 weeks
|
3.6%
2/55 • Number of events 3 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
3/56 • Number of events 3 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
11.1%
2/18 • Number of events 2 • 24 weeks
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/56 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 2 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/56 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/18 • 24 weeks
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
|
General disorders
Influenza like illness
|
1.8%
1/56 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/55 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER