Trial Outcomes & Findings for Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis (NCT NCT02780167)
NCT ID: NCT02780167
Last Updated: 2019-05-02
Results Overview
The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
269 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2019-05-02
Participant Flow
A total of 269 participants were randomized. There were 2 participants who were randomized but did not receive any study treatment. All other participants were treated.
Participant milestones
| Measure |
Placebo
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
49
|
51
|
56
|
55
|
|
Overall Study
COMPLETED
|
28
|
27
|
27
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
28
|
22
|
24
|
19
|
17
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
8
|
8
|
12
|
8
|
|
Overall Study
Lack of Efficacy
|
6
|
5
|
6
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Does not meet entrance criteria
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
No longer meets eligibility criteria
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
5
|
5
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
4
|
3
|
4
|
|
Overall Study
Other
|
0
|
0
|
3
|
1
|
2
|
Baseline Characteristics
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 15.6 • n=4 Participants
|
38.7 years
STANDARD_DEVIATION 17.6 • n=21 Participants
|
40.8 years
STANDARD_DEVIATION 16.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
144 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
123 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
194 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: "Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12
|
6.3 percentage of participants
Standard Error 2.55
|
8.2 percentage of participants
Standard Error 2.32
|
12.3 percentage of participants
Standard Error 2.88
|
27.8 percentage of participants
Standard Error 5.07
|
44.5 percentage of participants
Standard Error 6.92
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: "Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12
|
-35.22 percent change
Standard Error 6.572
|
-31.13 percent change
Standard Error 7.090
|
-40.73 percent change
Standard Error 6.823
|
-59.04 percent change
Standard Error 6.212
|
-82.57 percent change
Standard Error 6.161
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.Population: "Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Week 2
|
3.6 percentage of participants
|
6.1 percentage of participants
|
6.0 percentage of participants
|
3.6 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Week 6
|
14.5 percentage of participants
|
14.3 percentage of participants
|
14.0 percentage of participants
|
12.7 percentage of participants
|
40.7 percentage of participants
|
|
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Week 13
|
10.0 percentage of participants
|
20.7 percentage of participants
|
12.9 percentage of participants
|
23.7 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Week 16
|
10.7 percentage of participants
|
23.1 percentage of participants
|
7.4 percentage of participants
|
13.9 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Week 1
|
0.0 percentage of participants
|
2.1 percentage of participants
|
2.0 percentage of participants
|
1.8 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Week 4
|
1.8 percentage of participants
|
8.2 percentage of participants
|
8.0 percentage of participants
|
16.4 percentage of participants
|
40.7 percentage of participants
|
|
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Week 8
|
5.5 percentage of participants
|
8.2 percentage of participants
|
12.0 percentage of participants
|
16.4 percentage of participants
|
41.5 percentage of participants
|
|
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Week 14
|
18.8 percentage of participants
|
10.7 percentage of participants
|
3.4 percentage of participants
|
12.5 percentage of participants
|
15.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 1
|
1.9 percentage of participants
|
4.2 percentage of participants
|
6.1 percentage of participants
|
5.5 percentage of participants
|
9.4 percentage of participants
|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 2
|
7.3 percentage of participants
|
10.4 percentage of participants
|
10.6 percentage of participants
|
11.3 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 8
|
14.6 percentage of participants
|
19.4 percentage of participants
|
23.3 percentage of participants
|
34.0 percentage of participants
|
59.2 percentage of participants
|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 13
|
13.3 percentage of participants
|
24.1 percentage of participants
|
12.9 percentage of participants
|
26.3 percentage of participants
|
37.8 percentage of participants
|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 4
|
8.0 percentage of participants
|
11.1 percentage of participants
|
12.8 percentage of participants
|
25.0 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 6
|
22.7 percentage of participants
|
23.7 percentage of participants
|
18.6 percentage of participants
|
29.2 percentage of participants
|
59.6 percentage of participants
|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 12
|
17.1 percentage of participants
|
17.2 percentage of participants
|
23.3 percentage of participants
|
51.2 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 14
|
21.9 percentage of participants
|
17.9 percentage of participants
|
10.3 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Week 16
|
14.3 percentage of participants
|
26.9 percentage of participants
|
11.1 percentage of participants
|
22.2 percentage of participants
|
31.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Week 1
|
-12.28 Percent change
Standard Deviation 27.205
|
-13.80 Percent change
Standard Deviation 26.526
|
-14.85 Percent change
Standard Deviation 33.721
|
-19.85 Percent change
Standard Deviation 30.379
|
-41.26 Percent change
Standard Deviation 32.064
|
|
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Week 2
|
-23.54 Percent change
Standard Deviation 33.348
|
-14.79 Percent change
Standard Deviation 40.474
|
-26.29 Percent change
Standard Deviation 33.298
|
-38.26 Percent change
Standard Deviation 39.176
|
-63.28 Percent change
Standard Deviation 25.754
|
|
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Week 4
|
-24.58 Percent change
Standard Deviation 40.520
|
-30.06 Percent change
Standard Deviation 40.852
|
-32.81 Percent change
Standard Deviation 40.255
|
-53.59 Percent change
Standard Deviation 35.274
|
-78.16 Percent change
Standard Deviation 20.666
|
|
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Week 6
|
-39.17 Percent change
Standard Deviation 39.299
|
-35.18 Percent change
Standard Deviation 43.498
|
-40.16 Percent change
Standard Deviation 43.849
|
-54.16 Percent change
Standard Deviation 53.212
|
-83.14 Percent change
Standard Deviation 17.267
|
|
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Week 8
|
-36.69 Percent change
Standard Deviation 42.629
|
-39.43 Percent change
Standard Deviation 46.270
|
-36.83 Percent change
Standard Deviation 52.632
|
-53.96 Percent change
Standard Deviation 53.689
|
-84.48 Percent change
Standard Deviation 16.226
|
|
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Week 13
|
-29.82 Percent change
Standard Deviation 50.404
|
-34.11 Percent change
Standard Deviation 51.089
|
-32.97 Percent change
Standard Deviation 45.223
|
-51.23 Percent change
Standard Deviation 45.968
|
-66.34 Percent change
Standard Deviation 34.951
|
|
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Week 14
|
-35.51 Percent change
Standard Deviation 43.357
|
-31.54 Percent change
Standard Deviation 62.829
|
-26.25 Percent change
Standard Deviation 49.184
|
-38.80 Percent change
Standard Deviation 49.085
|
-57.15 Percent change
Standard Deviation 36.739
|
|
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Week 16
|
-35.91 Percent change
Standard Deviation 47.713
|
-45.24 Percent change
Standard Deviation 44.576
|
-20.80 Percent change
Standard Deviation 47.915
|
-27.66 Percent change
Standard Deviation 54.570
|
-55.82 Percent change
Standard Deviation 32.833
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 7
|
11.8 percentage of participants
|
13.3 percentage of participants
|
25.5 percentage of participants
|
30.2 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 9
|
8.3 percentage of participants
|
11.1 percentage of participants
|
26.1 percentage of participants
|
45.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 11
|
20.0 percentage of participants
|
15.6 percentage of participants
|
36.2 percentage of participants
|
45.5 percentage of participants
|
63.5 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 113
|
47.8 percentage of participants
|
25.0 percentage of participants
|
20.0 percentage of participants
|
47.2 percentage of participants
|
38.2 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 8
|
16.0 percentage of participants
|
11.1 percentage of participants
|
29.2 percentage of participants
|
45.5 percentage of participants
|
60.8 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 9
|
14.6 percentage of participants
|
13.3 percentage of participants
|
30.4 percentage of participants
|
45.5 percentage of participants
|
55.8 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 10
|
14.3 percentage of participants
|
13.3 percentage of participants
|
36.2 percentage of participants
|
45.5 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 12
|
18.0 percentage of participants
|
17.8 percentage of participants
|
38.3 percentage of participants
|
50.9 percentage of participants
|
60.8 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 13
|
20.0 percentage of participants
|
20.0 percentage of participants
|
30.4 percentage of participants
|
51.9 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 14
|
24.5 percentage of participants
|
23.8 percentage of participants
|
33.3 percentage of participants
|
48.1 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 15
|
30.0 percentage of participants
|
20.5 percentage of participants
|
38.5 percentage of participants
|
52.3 percentage of participants
|
72.5 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 29
|
28.8 percentage of participants
|
28.9 percentage of participants
|
40.0 percentage of participants
|
60.0 percentage of participants
|
74.5 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 43
|
23.5 percentage of participants
|
35.4 percentage of participants
|
38.3 percentage of participants
|
57.4 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 57
|
26.9 percentage of participants
|
29.8 percentage of participants
|
38.3 percentage of participants
|
54.5 percentage of participants
|
74.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 85
|
25.0 percentage of participants
|
25.5 percentage of participants
|
34.8 percentage of participants
|
53.7 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 99
|
30.0 percentage of participants
|
22.2 percentage of participants
|
37.0 percentage of participants
|
47.5 percentage of participants
|
39.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 2
|
4.0 percentage of participants
|
6.7 percentage of participants
|
17.0 percentage of participants
|
14.8 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 3
|
8.0 percentage of participants
|
2.2 percentage of participants
|
14.9 percentage of participants
|
22.2 percentage of participants
|
28.3 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 4
|
2.0 percentage of participants
|
2.2 percentage of participants
|
21.3 percentage of participants
|
22.2 percentage of participants
|
34.6 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 5
|
2.0 percentage of participants
|
6.7 percentage of participants
|
29.8 percentage of participants
|
24.1 percentage of participants
|
36.5 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 6
|
10.0 percentage of participants
|
8.9 percentage of participants
|
25.5 percentage of participants
|
24.1 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 8
|
10.0 percentage of participants
|
13.3 percentage of participants
|
25.0 percentage of participants
|
43.6 percentage of participants
|
51.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 10
|
8.2 percentage of participants
|
11.1 percentage of participants
|
34.0 percentage of participants
|
43.6 percentage of participants
|
55.8 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 11
|
16.0 percentage of participants
|
15.6 percentage of participants
|
27.7 percentage of participants
|
43.6 percentage of participants
|
57.7 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 12
|
22.0 percentage of participants
|
17.8 percentage of participants
|
38.3 percentage of participants
|
49.1 percentage of participants
|
60.8 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 13
|
24.0 percentage of participants
|
15.6 percentage of participants
|
28.3 percentage of participants
|
53.8 percentage of participants
|
66.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 14
|
22.4 percentage of participants
|
19.0 percentage of participants
|
26.7 percentage of participants
|
48.1 percentage of participants
|
67.3 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 15
|
25.0 percentage of participants
|
17.9 percentage of participants
|
30.8 percentage of participants
|
54.5 percentage of participants
|
72.5 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 29
|
32.7 percentage of participants
|
31.1 percentage of participants
|
37.8 percentage of participants
|
60.0 percentage of participants
|
74.5 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 43
|
31.4 percentage of participants
|
35.4 percentage of participants
|
38.3 percentage of participants
|
53.7 percentage of participants
|
73.1 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 57
|
28.8 percentage of participants
|
31.9 percentage of participants
|
38.3 percentage of participants
|
54.5 percentage of participants
|
72.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 85
|
26.9 percentage of participants
|
21.3 percentage of participants
|
41.3 percentage of participants
|
53.7 percentage of participants
|
64.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 99
|
33.3 percentage of participants
|
25.9 percentage of participants
|
33.3 percentage of participants
|
47.5 percentage of participants
|
41.5 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Itching due to AD Day 113
|
52.2 percentage of participants
|
29.2 percentage of participants
|
24.0 percentage of participants
|
44.4 percentage of participants
|
35.3 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 2
|
6.0 percentage of participants
|
8.9 percentage of participants
|
19.1 percentage of participants
|
22.2 percentage of participants
|
26.4 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 3
|
10.0 percentage of participants
|
8.9 percentage of participants
|
19.1 percentage of participants
|
25.9 percentage of participants
|
34.0 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 4
|
8.0 percentage of participants
|
4.4 percentage of participants
|
23.4 percentage of participants
|
25.9 percentage of participants
|
48.1 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 5
|
10.0 percentage of participants
|
6.7 percentage of participants
|
31.9 percentage of participants
|
29.6 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 6
|
14.0 percentage of participants
|
8.9 percentage of participants
|
27.7 percentage of participants
|
33.3 percentage of participants
|
57.7 percentage of participants
|
|
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 7
|
15.7 percentage of participants
|
11.1 percentage of participants
|
31.9 percentage of participants
|
34.0 percentage of participants
|
55.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 4
|
0.0 percentage of participants
|
0.0 percentage of participants
|
17.4 percentage of participants
|
14.0 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 5
|
2.0 percentage of participants
|
2.2 percentage of participants
|
19.6 percentage of participants
|
20.0 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 6
|
6.1 percentage of participants
|
2.2 percentage of participants
|
17.4 percentage of participants
|
24.0 percentage of participants
|
35.6 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 7
|
8.0 percentage of participants
|
8.9 percentage of participants
|
19.6 percentage of participants
|
20.4 percentage of participants
|
37.8 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 9
|
2.1 percentage of participants
|
6.7 percentage of participants
|
20.0 percentage of participants
|
27.5 percentage of participants
|
51.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 15
|
20.0 percentage of participants
|
15.8 percentage of participants
|
35.3 percentage of participants
|
36.4 percentage of participants
|
71.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 29
|
16.3 percentage of participants
|
15.9 percentage of participants
|
35.0 percentage of participants
|
51.9 percentage of participants
|
66.0 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 43
|
12.5 percentage of participants
|
24.4 percentage of participants
|
28.6 percentage of participants
|
58.8 percentage of participants
|
72.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 57
|
16.3 percentage of participants
|
20.5 percentage of participants
|
33.3 percentage of participants
|
53.8 percentage of participants
|
73.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 85
|
24.5 percentage of participants
|
25.0 percentage of participants
|
28.6 percentage of participants
|
47.1 percentage of participants
|
69.6 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 113
|
34.8 percentage of participants
|
20.8 percentage of participants
|
22.7 percentage of participants
|
29.4 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 2
|
2.0 percentage of participants
|
2.2 percentage of participants
|
6.5 percentage of participants
|
10.0 percentage of participants
|
15.2 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 3
|
0.0 percentage of participants
|
2.2 percentage of participants
|
13.0 percentage of participants
|
14.0 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 8
|
6.1 percentage of participants
|
4.4 percentage of participants
|
14.9 percentage of participants
|
29.4 percentage of participants
|
52.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 10
|
4.2 percentage of participants
|
6.7 percentage of participants
|
21.7 percentage of participants
|
29.4 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 11
|
8.2 percentage of participants
|
13.3 percentage of participants
|
19.6 percentage of participants
|
29.4 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 12
|
10.2 percentage of participants
|
11.1 percentage of participants
|
23.9 percentage of participants
|
35.3 percentage of participants
|
51.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 13
|
14.3 percentage of participants
|
6.7 percentage of participants
|
20.0 percentage of participants
|
38.8 percentage of participants
|
61.4 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 14
|
10.4 percentage of participants
|
14.3 percentage of participants
|
25.0 percentage of participants
|
41.7 percentage of participants
|
59.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 15
|
15.0 percentage of participants
|
7.9 percentage of participants
|
31.6 percentage of participants
|
41.9 percentage of participants
|
70.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 29
|
17.6 percentage of participants
|
13.6 percentage of participants
|
25.0 percentage of participants
|
52.9 percentage of participants
|
68.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 43
|
20.0 percentage of participants
|
22.2 percentage of participants
|
23.9 percentage of participants
|
50.0 percentage of participants
|
71.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 57
|
17.6 percentage of participants
|
22.7 percentage of participants
|
26.1 percentage of participants
|
52.9 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 85
|
25.5 percentage of participants
|
22.7 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
63.6 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 99
|
27.6 percentage of participants
|
25.9 percentage of participants
|
23.1 percentage of participants
|
38.5 percentage of participants
|
37.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 113
|
43.5 percentage of participants
|
20.8 percentage of participants
|
16.7 percentage of participants
|
34.3 percentage of participants
|
31.0 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 2
|
2.1 percentage of participants
|
0.0 percentage of participants
|
7.1 percentage of participants
|
11.5 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 3
|
6.4 percentage of participants
|
2.2 percentage of participants
|
11.9 percentage of participants
|
13.5 percentage of participants
|
22.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 4
|
2.1 percentage of participants
|
0.0 percentage of participants
|
19.0 percentage of participants
|
21.2 percentage of participants
|
36.2 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 5
|
4.3 percentage of participants
|
4.4 percentage of participants
|
23.8 percentage of participants
|
25.0 percentage of participants
|
38.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 6
|
10.6 percentage of participants
|
6.7 percentage of participants
|
26.2 percentage of participants
|
25.0 percentage of participants
|
44.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 7
|
10.4 percentage of participants
|
4.4 percentage of participants
|
19.0 percentage of participants
|
30.0 percentage of participants
|
51.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 8
|
8.5 percentage of participants
|
2.2 percentage of participants
|
23.3 percentage of participants
|
36.5 percentage of participants
|
54.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 9
|
6.7 percentage of participants
|
6.7 percentage of participants
|
26.8 percentage of participants
|
36.5 percentage of participants
|
48.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 10
|
6.5 percentage of participants
|
8.9 percentage of participants
|
31.0 percentage of participants
|
28.8 percentage of participants
|
51.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 11
|
10.6 percentage of participants
|
15.6 percentage of participants
|
23.8 percentage of participants
|
32.7 percentage of participants
|
55.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 12
|
12.8 percentage of participants
|
13.3 percentage of participants
|
26.2 percentage of participants
|
34.6 percentage of participants
|
54.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 13
|
17.0 percentage of participants
|
15.6 percentage of participants
|
29.3 percentage of participants
|
32.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 14
|
19.6 percentage of participants
|
16.7 percentage of participants
|
30.0 percentage of participants
|
34.7 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 99
|
20.7 percentage of participants
|
18.5 percentage of participants
|
16.7 percentage of participants
|
39.5 percentage of participants
|
32.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline till Week 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Time to Achieving >=3 Points Improvement in NRS
Itching due to AD
|
30.0 day
Interval 15.0 to 56.0
|
43.0 day
Interval 29.0 to 57.0
|
12.0 day
Interval 8.0 to 30.0
|
9.0 day
Interval 7.0 to 14.0
|
7.0 day
Interval 5.0 to 11.0
|
|
Time to Achieving >=3 Points Improvement in NRS
Frequency of itching due to AD
|
29.0 day
Interval 13.0 to 57.0
|
43.0 day
Interval 29.0 to 85.0
|
13.0 day
Interval 7.0 to 43.0
|
8.0 day
Interval 4.0 to 10.0
|
4.0 day
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline till Week 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Time to Achieving >=4 Points Improvement in NRS
Itching due to atopic dermatitis
|
78.0 day
Interval 56.0 to
The NA was generated because of the high censoring rates in the placebo group.
|
NA day
Interval 47.0 to
The NA was generated because of the high censoring rates in the PF-04965842 10 mg group.
|
43.0 day
Interval 15.0 to 85.0
|
14.0 day
Interval 10.0 to 29.0
|
10.0 day
Interval 7.0 to 13.0
|
|
Time to Achieving >=4 Points Improvement in NRS
Frequency of itching due to atopic dermatitis
|
59.0 day
Interval 30.0 to
The NA was generated because of the high censoring rates in the placebo group.
|
NA day
Interval 56.0 to
The NA was generated because of the high censoring rates in the PF-04965842 10 mg group.
|
29.0 day
Interval 12.0 to 98.0
|
14.0 day
Interval 8.0 to 29.0
|
7.0 day
Interval 5.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 2
|
0.56 percent change
Standard Deviation 19.298
|
-1.51 percent change
Standard Deviation 19.857
|
-9.39 percent change
Standard Deviation 23.528
|
-10.06 percent change
Standard Deviation 25.930
|
-6.79 percent change
Standard Deviation 47.751
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 3
|
-1.32 percent change
Standard Deviation 22.630
|
2.48 percent change
Standard Deviation 21.994
|
-8.22 percent change
Standard Deviation 33.257
|
-15.32 percent change
Standard Deviation 27.874
|
-16.72 percent change
Standard Deviation 40.055
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 4
|
-1.98 percent change
Standard Deviation 22.326
|
0.23 percent change
Standard Deviation 17.314
|
-12.18 percent change
Standard Deviation 33.385
|
-17.62 percent change
Standard Deviation 25.747
|
-25.80 percent change
Standard Deviation 38.557
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 5
|
-2.98 percent change
Standard Deviation 22.385
|
-2.37 percent change
Standard Deviation 20.174
|
-18.92 percent change
Standard Deviation 31.846
|
-20.48 percent change
Standard Deviation 27.983
|
-30.91 percent change
Standard Deviation 34.215
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 6
|
-1.52 percent change
Standard Deviation 25.690
|
-5.70 percent change
Standard Deviation 23.478
|
-16.70 percent change
Standard Deviation 33.407
|
-21.58 percent change
Standard Deviation 27.842
|
-34.02 percent change
Standard Deviation 35.532
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 7
|
-4.18 percent change
Standard Deviation 30.531
|
-4.59 percent change
Standard Deviation 28.248
|
-18.07 percent change
Standard Deviation 33.640
|
-23.02 percent change
Standard Deviation 33.524
|
-38.17 percent change
Standard Deviation 35.428
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 8
|
-0.35 percent change
Standard Deviation 34.144
|
-5.69 percent change
Standard Deviation 25.576
|
-17.87 percent change
Standard Deviation 34.789
|
-32.36 percent change
Standard Deviation 30.610
|
-43.13 percent change
Standard Deviation 38.684
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 9
|
-2.56 percent change
Standard Deviation 30.688
|
-8.61 percent change
Standard Deviation 27.803
|
-22.74 percent change
Standard Deviation 33.667
|
-31.82 percent change
Standard Deviation 30.951
|
-39.37 percent change
Standard Deviation 41.055
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 10
|
-3.32 percent change
Standard Deviation 29.885
|
-5.97 percent change
Standard Deviation 29.093
|
-22.90 percent change
Standard Deviation 41.573
|
-31.93 percent change
Standard Deviation 27.094
|
-39.60 percent change
Standard Deviation 56.607
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 11
|
-7.81 percent change
Standard Deviation 30.201
|
-5.94 percent change
Standard Deviation 31.028
|
-16.76 percent change
Standard Deviation 49.412
|
-33.13 percent change
Standard Deviation 27.902
|
-42.50 percent change
Standard Deviation 51.621
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 12
|
-11.12 percent change
Standard Deviation 30.087
|
-6.65 percent change
Standard Deviation 32.617
|
-27.84 percent change
Standard Deviation 33.416
|
-33.30 percent change
Standard Deviation 34.252
|
-46.40 percent change
Standard Deviation 46.241
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 13
|
-15.16 percent change
Standard Deviation 29.759
|
-7.43 percent change
Standard Deviation 27.374
|
-24.56 percent change
Standard Deviation 30.086
|
-35.89 percent change
Standard Deviation 35.651
|
-49.77 percent change
Standard Deviation 48.426
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 14
|
-13.61 percent change
Standard Deviation 30.153
|
-8.84 percent change
Standard Deviation 29.474
|
-26.70 percent change
Standard Deviation 29.805
|
-36.57 percent change
Standard Deviation 27.552
|
-55.45 percent change
Standard Deviation 34.331
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 15
|
-17.24 percent change
Standard Deviation 30.755
|
-7.28 percent change
Standard Deviation 28.058
|
-25.09 percent change
Standard Deviation 37.815
|
-35.41 percent change
Standard Deviation 29.140
|
-59.00 percent change
Standard Deviation 39.804
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 29
|
-19.43 percent change
Standard Deviation 35.575
|
-16.63 percent change
Standard Deviation 34.554
|
-28.41 percent change
Standard Deviation 36.183
|
-46.62 percent change
Standard Deviation 40.090
|
-68.09 percent change
Standard Deviation 31.214
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 43
|
-26.55 percent change
Standard Deviation 36.418
|
-27.15 percent change
Standard Deviation 39.550
|
-31.14 percent change
Standard Deviation 39.090
|
-49.49 percent change
Standard Deviation 46.279
|
-67.80 percent change
Standard Deviation 36.372
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 57
|
-25.54 percent change
Standard Deviation 39.577
|
-21.60 percent change
Standard Deviation 44.446
|
-29.60 percent change
Standard Deviation 39.606
|
-54.11 percent change
Standard Deviation 36.374
|
-70.13 percent change
Standard Deviation 36.338
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 85
|
-30.10 percent change
Standard Deviation 42.697
|
-22.47 percent change
Standard Deviation 48.291
|
-30.39 percent change
Standard Deviation 47.772
|
-56.51 percent change
Standard Deviation 41.955
|
-53.66 percent change
Standard Deviation 109.454
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 99
|
-19.24 percent change
Standard Deviation 43.251
|
-15.94 percent change
Standard Deviation 42.332
|
-11.46 percent change
Standard Deviation 39.959
|
-32.68 percent change
Standard Deviation 34.789
|
5.61 percent change
Standard Deviation 139.223
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Itching due to AD Day 113
|
-31.99 percent change
Standard Deviation 45.929
|
-14.07 percent change
Standard Deviation 47.186
|
-14.34 percent change
Standard Deviation 29.756
|
-28.47 percent change
Standard Deviation 41.027
|
24.61 percent change
Standard Deviation 190.848
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 2
|
6.72 percent change
Standard Deviation 45.759
|
-6.67 percent change
Standard Deviation 19.016
|
-10.14 percent change
Standard Deviation 28.184
|
-17.93 percent change
Standard Deviation 20.967
|
-10.52 percent change
Standard Deviation 79.180
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 3
|
2.59 percent change
Standard Deviation 45.541
|
0.30 percent change
Standard Deviation 24.330
|
-3.96 percent change
Standard Deviation 49.425
|
-19.98 percent change
Standard Deviation 22.910
|
-16.46 percent change
Standard Deviation 67.794
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 4
|
3.73 percent change
Standard Deviation 37.683
|
-3.25 percent change
Standard Deviation 15.230
|
-9.39 percent change
Standard Deviation 39.225
|
-20.71 percent change
Standard Deviation 24.391
|
-28.27 percent change
Standard Deviation 47.925
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 5
|
-0.70 percent change
Standard Deviation 34.834
|
-3.73 percent change
Standard Deviation 23.125
|
-17.72 percent change
Standard Deviation 38.967
|
-23.69 percent change
Standard Deviation 24.954
|
-35.45 percent change
Standard Deviation 37.436
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 6
|
4.04 percent change
Standard Deviation 52.799
|
-5.76 percent change
Standard Deviation 24.623
|
-14.84 percent change
Standard Deviation 38.256
|
-26.47 percent change
Standard Deviation 27.218
|
-44.31 percent change
Standard Deviation 36.476
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 7
|
-2.25 percent change
Standard Deviation 37.193
|
-3.56 percent change
Standard Deviation 25.414
|
-17.05 percent change
Standard Deviation 40.108
|
-27.80 percent change
Standard Deviation 32.466
|
-40.19 percent change
Standard Deviation 39.702
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 8
|
1.22 percent change
Standard Deviation 38.544
|
-3.90 percent change
Standard Deviation 25.515
|
-19.05 percent change
Standard Deviation 36.488
|
-35.44 percent change
Standard Deviation 29.791
|
-46.26 percent change
Standard Deviation 43.491
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 9
|
1.08 percent change
Standard Deviation 58.633
|
-8.79 percent change
Standard Deviation 26.589
|
-17.58 percent change
Standard Deviation 42.054
|
-35.17 percent change
Standard Deviation 29.637
|
-44.29 percent change
Standard Deviation 43.238
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 10
|
-3.47 percent change
Standard Deviation 53.518
|
-5.41 percent change
Standard Deviation 32.491
|
-19.84 percent change
Standard Deviation 47.884
|
-33.23 percent change
Standard Deviation 26.950
|
-49.78 percent change
Standard Deviation 37.349
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 11
|
-6.24 percent change
Standard Deviation 49.163
|
-5.88 percent change
Standard Deviation 32.750
|
-18.73 percent change
Standard Deviation 42.599
|
-34.93 percent change
Standard Deviation 27.181
|
-51.62 percent change
Standard Deviation 37.385
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 12
|
-8.41 percent change
Standard Deviation 49.918
|
-5.65 percent change
Standard Deviation 36.637
|
-25.00 percent change
Standard Deviation 31.695
|
-36.55 percent change
Standard Deviation 27.281
|
-51.92 percent change
Standard Deviation 40.010
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 13
|
-13.45 percent change
Standard Deviation 40.159
|
-10.46 percent change
Standard Deviation 31.103
|
-24.73 percent change
Standard Deviation 31.960
|
-35.75 percent change
Standard Deviation 32.757
|
-53.17 percent change
Standard Deviation 40.695
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 14
|
-10.26 percent change
Standard Deviation 46.126
|
-13.86 percent change
Standard Deviation 32.390
|
-27.70 percent change
Standard Deviation 30.476
|
-38.28 percent change
Standard Deviation 27.724
|
-57.50 percent change
Standard Deviation 39.073
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 15
|
-18.78 percent change
Standard Deviation 34.923
|
-11.34 percent change
Standard Deviation 28.494
|
-26.88 percent change
Standard Deviation 38.846
|
-38.87 percent change
Standard Deviation 29.184
|
-60.99 percent change
Standard Deviation 32.840
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 29
|
-16.05 percent change
Standard Deviation 39.630
|
-17.15 percent change
Standard Deviation 33.432
|
-28.55 percent change
Standard Deviation 43.421
|
-49.94 percent change
Standard Deviation 36.649
|
-67.84 percent change
Standard Deviation 29.918
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 43
|
-24.51 percent change
Standard Deviation 30.798
|
-32.19 percent change
Standard Deviation 37.806
|
-26.48 percent change
Standard Deviation 46.793
|
-53.95 percent change
Standard Deviation 41.772
|
-69.24 percent change
Standard Deviation 38.370
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 57
|
-24.94 percent change
Standard Deviation 35.662
|
-23.28 percent change
Standard Deviation 44.257
|
-27.91 percent change
Standard Deviation 39.142
|
-55.39 percent change
Standard Deviation 35.447
|
-73.50 percent change
Standard Deviation 30.583
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 85
|
-29.81 percent change
Standard Deviation 44.035
|
-25.76 percent change
Standard Deviation 43.273
|
-32.28 percent change
Standard Deviation 38.817
|
-54.51 percent change
Standard Deviation 43.354
|
-54.54 percent change
Standard Deviation 120.723
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 99
|
-17.46 percent change
Standard Deviation 43.552
|
-20.21 percent change
Standard Deviation 36.947
|
-3.36 percent change
Standard Deviation 52.153
|
-13.57 percent change
Standard Deviation 123.800
|
2.12 percent change
Standard Deviation 144.572
|
|
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Frequency of itching due to AD Day 113
|
-28.95 percent change
Standard Deviation 46.896
|
-16.22 percent change
Standard Deviation 38.055
|
-5.65 percent change
Standard Deviation 51.132
|
-12.62 percent change
Standard Deviation 113.423
|
27.77 percent change
Standard Deviation 203.937
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 2
|
-0.08 units on a scale
Standard Deviation 1.307
|
-0.20 units on a scale
Standard Deviation 1.217
|
-0.83 units on a scale
Standard Deviation 1.672
|
-0.85 units on a scale
Standard Deviation 1.607
|
-1.00 units on a scale
Standard Deviation 2.433
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 3
|
-0.22 units on a scale
Standard Deviation 1.418
|
0.02 units on a scale
Standard Deviation 1.357
|
-0.85 units on a scale
Standard Deviation 2.095
|
-1.21 units on a scale
Standard Deviation 1.702
|
-1.48 units on a scale
Standard Deviation 2.493
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 4
|
-0.22 units on a scale
Standard Deviation 1.389
|
-0.09 units on a scale
Standard Deviation 1.117
|
-1.09 units on a scale
Standard Deviation 2.263
|
-1.26 units on a scale
Standard Deviation 1.862
|
-2.12 units on a scale
Standard Deviation 2.590
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 5
|
-0.32 units on a scale
Standard Deviation 1.406
|
-0.27 units on a scale
Standard Deviation 1.264
|
-1.55 units on a scale
Standard Deviation 2.348
|
-1.58 units on a scale
Standard Deviation 1.865
|
-2.35 units on a scale
Standard Deviation 2.583
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 8
|
-0.30 units on a scale
Standard Deviation 2.215
|
-0.56 units on a scale
Standard Deviation 1.560
|
-1.65 units on a scale
Standard Deviation 2.514
|
-2.39 units on a scale
Standard Deviation 2.294
|
-3.22 units on a scale
Standard Deviation 3.039
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 9
|
-0.38 units on a scale
Standard Deviation 2.080
|
-0.75 units on a scale
Standard Deviation 1.844
|
-1.95 units on a scale
Standard Deviation 2.527
|
-2.40 units on a scale
Standard Deviation 2.154
|
-3.18 units on a scale
Standard Deviation 2.988
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 12
|
-0.92 units on a scale
Standard Deviation 1.988
|
-0.73 units on a scale
Standard Deviation 2.245
|
-2.28 units on a scale
Standard Deviation 2.271
|
-2.46 units on a scale
Standard Deviation 2.578
|
-3.63 units on a scale
Standard Deviation 3.154
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 13
|
-1.21 units on a scale
Standard Deviation 1.989
|
-0.68 units on a scale
Standard Deviation 1.801
|
-1.98 units on a scale
Standard Deviation 2.268
|
-2.84 units on a scale
Standard Deviation 2.164
|
-3.88 units on a scale
Standard Deviation 3.085
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 29
|
-1.63 units on a scale
Standard Deviation 2.453
|
-1.34 units on a scale
Standard Deviation 2.383
|
-2.17 units on a scale
Standard Deviation 2.519
|
-3.58 units on a scale
Standard Deviation 3.322
|
-5.00 units on a scale
Standard Deviation 2.880
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 43
|
-1.93 units on a scale
Standard Deviation 2.325
|
-2.24 units on a scale
Standard Deviation 2.929
|
-2.50 units on a scale
Standard Deviation 2.562
|
-3.77 units on a scale
Standard Deviation 3.778
|
-5.02 units on a scale
Standard Deviation 3.172
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 3
|
-0.38 units on a scale
Standard Deviation 1.894
|
-0.16 units on a scale
Standard Deviation 1.461
|
-0.79 units on a scale
Standard Deviation 2.331
|
-1.49 units on a scale
Standard Deviation 1.694
|
-1.92 units on a scale
Standard Deviation 2.300
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 4
|
-0.20 units on a scale
Standard Deviation 1.738
|
-0.32 units on a scale
Standard Deviation 1.073
|
-1.02 units on a scale
Standard Deviation 2.162
|
-1.40 units on a scale
Standard Deviation 2.069
|
-2.47 units on a scale
Standard Deviation 2.533
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 5
|
-0.42 units on a scale
Standard Deviation 1.727
|
-0.43 units on a scale
Standard Deviation 1.516
|
-1.49 units on a scale
Standard Deviation 2.349
|
-1.75 units on a scale
Standard Deviation 1.828
|
-2.73 units on a scale
Standard Deviation 2.515
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 6
|
-0.40 units on a scale
Standard Deviation 2.250
|
-0.55 units on a scale
Standard Deviation 1.606
|
-1.40 units on a scale
Standard Deviation 2.402
|
-1.77 units on a scale
Standard Deviation 2.326
|
-3.24 units on a scale
Standard Deviation 2.446
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 8
|
-0.42 units on a scale
Standard Deviation 2.205
|
-0.40 units on a scale
Standard Deviation 1.679
|
-1.74 units on a scale
Standard Deviation 2.542
|
-2.59 units on a scale
Standard Deviation 2.278
|
-3.69 units on a scale
Standard Deviation 2.808
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 9
|
-0.54 units on a scale
Standard Deviation 2.240
|
-0.75 units on a scale
Standard Deviation 2.036
|
-1.74 units on a scale
Standard Deviation 2.567
|
-2.62 units on a scale
Standard Deviation 2.268
|
-3.54 units on a scale
Standard Deviation 3.018
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 11
|
-0.96 units on a scale
Standard Deviation 2.336
|
-0.68 units on a scale
Standard Deviation 2.380
|
-1.79 units on a scale
Standard Deviation 2.541
|
-2.46 units on a scale
Standard Deviation 2.540
|
-3.74 units on a scale
Standard Deviation 2.633
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 15
|
-1.50 units on a scale
Standard Deviation 2.322
|
-0.97 units on a scale
Standard Deviation 2.135
|
-2.17 units on a scale
Standard Deviation 2.407
|
-3.02 units on a scale
Standard Deviation 2.464
|
-4.50 units on a scale
Standard Deviation 2.648
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 43
|
-1.70 units on a scale
Standard Deviation 1.990
|
-2.51 units on a scale
Standard Deviation 3.061
|
-2.28 units on a scale
Standard Deviation 2.953
|
-4.02 units on a scale
Standard Deviation 3.796
|
-5.30 units on a scale
Standard Deviation 2.957
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 57
|
-1.74 units on a scale
Standard Deviation 2.298
|
-2.00 units on a scale
Standard Deviation 3.499
|
-2.45 units on a scale
Standard Deviation 2.943
|
-4.02 units on a scale
Standard Deviation 3.467
|
-5.59 units on a scale
Standard Deviation 3.037
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 85
|
-2.23 units on a scale
Standard Deviation 3.209
|
-2.33 units on a scale
Standard Deviation 3.575
|
-2.61 units on a scale
Standard Deviation 2.692
|
-4.09 units on a scale
Standard Deviation 3.663
|
-5.14 units on a scale
Standard Deviation 3.645
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 99
|
-1.30 units on a scale
Standard Deviation 2.781
|
-1.56 units on a scale
Standard Deviation 2.736
|
-0.93 units on a scale
Standard Deviation 2.526
|
-2.03 units on a scale
Standard Deviation 3.378
|
-2.15 units on a scale
Standard Deviation 3.909
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 57
|
-1.84 units on a scale
Standard Deviation 2.594
|
-1.97 units on a scale
Standard Deviation 3.398
|
-2.55 units on a scale
Standard Deviation 2.943
|
-4.00 units on a scale
Standard Deviation 3.336
|
-5.26 units on a scale
Standard Deviation 3.130
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 6
|
-0.28 units on a scale
Standard Deviation 1.727
|
-0.55 units on a scale
Standard Deviation 1.405
|
-1.47 units on a scale
Standard Deviation 2.492
|
-1.49 units on a scale
Standard Deviation 2.317
|
-2.53 units on a scale
Standard Deviation 2.648
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 7
|
-0.53 units on a scale
Standard Deviation 2.023
|
-0.52 units on a scale
Standard Deviation 1.745
|
-1.51 units on a scale
Standard Deviation 2.422
|
-1.75 units on a scale
Standard Deviation 2.159
|
-2.77 units on a scale
Standard Deviation 2.795
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 10
|
-0.43 units on a scale
Standard Deviation 1.947
|
-0.61 units on a scale
Standard Deviation 1.967
|
-2.09 units on a scale
Standard Deviation 2.698
|
-2.21 units on a scale
Standard Deviation 2.412
|
-3.38 units on a scale
Standard Deviation 2.975
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 11
|
-0.73 units on a scale
Standard Deviation 1.955
|
-0.61 units on a scale
Standard Deviation 2.148
|
-1.72 units on a scale
Standard Deviation 2.462
|
-2.33 units on a scale
Standard Deviation 2.415
|
-3.40 units on a scale
Standard Deviation 3.071
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 85
|
-2.26 units on a scale
Standard Deviation 3.081
|
-2.13 units on a scale
Standard Deviation 3.711
|
-2.68 units on a scale
Standard Deviation 2.749
|
-4.21 units on a scale
Standard Deviation 3.529
|
-4.84 units on a scale
Standard Deviation 3.785
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 14
|
-1.11 units on a scale
Standard Deviation 2.003
|
-0.78 units on a scale
Standard Deviation 2.104
|
-2.10 units on a scale
Standard Deviation 2.211
|
-2.53 units on a scale
Standard Deviation 2.567
|
-4.06 units on a scale
Standard Deviation 2.793
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 15
|
-1.39 units on a scale
Standard Deviation 2.034
|
-0.69 units on a scale
Standard Deviation 1.937
|
-2.06 units on a scale
Standard Deviation 2.508
|
-2.79 units on a scale
Standard Deviation 2.290
|
-4.37 units on a scale
Standard Deviation 2.696
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 99
|
-1.57 units on a scale
Standard Deviation 3.025
|
-1.48 units on a scale
Standard Deviation 2.992
|
-1.37 units on a scale
Standard Deviation 2.452
|
-2.28 units on a scale
Standard Deviation 2.900
|
-1.90 units on a scale
Standard Deviation 3.767
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Itching due to AD Day 113
|
-2.43 units on a scale
Standard Deviation 3.259
|
-1.38 units on a scale
Standard Deviation 3.201
|
-1.32 units on a scale
Standard Deviation 2.410
|
-2.03 units on a scale
Standard Deviation 3.185
|
-1.50 units on a scale
Standard Deviation 3.736
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 2
|
-0.06 units on a scale
Standard Deviation 1.754
|
-0.44 units on a scale
Standard Deviation 1.198
|
-0.94 units on a scale
Standard Deviation 1.737
|
-1.35 units on a scale
Standard Deviation 1.556
|
-1.60 units on a scale
Standard Deviation 2.345
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 7
|
-0.63 units on a scale
Standard Deviation 2.181
|
-0.43 units on a scale
Standard Deviation 1.676
|
-1.53 units on a scale
Standard Deviation 2.466
|
-2.04 units on a scale
Standard Deviation 2.214
|
-3.15 units on a scale
Standard Deviation 2.739
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 10
|
-0.80 units on a scale
Standard Deviation 2.198
|
-0.64 units on a scale
Standard Deviation 2.200
|
-1.84 units on a scale
Standard Deviation 2.760
|
-2.33 units on a scale
Standard Deviation 2.565
|
-3.68 units on a scale
Standard Deviation 2.591
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 12
|
-1.06 units on a scale
Standard Deviation 2.322
|
-0.66 units on a scale
Standard Deviation 2.411
|
-2.00 units on a scale
Standard Deviation 2.182
|
-2.54 units on a scale
Standard Deviation 2.509
|
-3.84 units on a scale
Standard Deviation 2.932
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 13
|
-1.33 units on a scale
Standard Deviation 2.337
|
-0.91 units on a scale
Standard Deviation 2.133
|
-1.90 units on a scale
Standard Deviation 2.195
|
-2.78 units on a scale
Standard Deviation 2.275
|
-4.08 units on a scale
Standard Deviation 2.952
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 14
|
-1.17 units on a scale
Standard Deviation 2.417
|
-1.10 units on a scale
Standard Deviation 2.417
|
-2.00 units on a scale
Standard Deviation 2.225
|
-2.63 units on a scale
Standard Deviation 2.620
|
-4.28 units on a scale
Standard Deviation 2.841
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 29
|
-1.46 units on a scale
Standard Deviation 2.518
|
-1.34 units on a scale
Standard Deviation 2.425
|
-2.22 units on a scale
Standard Deviation 2.761
|
-3.77 units on a scale
Standard Deviation 3.317
|
-5.06 units on a scale
Standard Deviation 2.817
|
|
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Frequency of itching due to AD Day 113
|
-2.00 units on a scale
Standard Deviation 2.970
|
-1.42 units on a scale
Standard Deviation 3.035
|
-1.04 units on a scale
Standard Deviation 2.557
|
-1.81 units on a scale
Standard Deviation 3.188
|
-1.50 units on a scale
Standard Deviation 3.816
|
SECONDARY outcome
Timeframe: All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 1
|
9.3 percentage of participants
|
8.3 percentage of participants
|
14.0 percentage of participants
|
12.7 percentage of participants
|
40.7 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 4
|
27.3 percentage of participants
|
30.6 percentage of participants
|
36.0 percentage of participants
|
58.2 percentage of participants
|
85.2 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 6
|
36.4 percentage of participants
|
30.6 percentage of participants
|
40.0 percentage of participants
|
60.0 percentage of participants
|
90.7 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 12
|
26.9 percentage of participants
|
26.1 percentage of participants
|
33.3 percentage of participants
|
55.6 percentage of participants
|
79.2 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 2
|
27.3 percentage of participants
|
16.3 percentage of participants
|
24.0 percentage of participants
|
36.4 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 8
|
30.9 percentage of participants
|
36.7 percentage of participants
|
40.0 percentage of participants
|
60.0 percentage of participants
|
90.6 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 13
|
43.3 percentage of participants
|
41.4 percentage of participants
|
45.2 percentage of participants
|
55.3 percentage of participants
|
75.6 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 14
|
37.5 percentage of participants
|
42.9 percentage of participants
|
37.9 percentage of participants
|
50.0 percentage of participants
|
65.9 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Week 16
|
42.9 percentage of participants
|
42.3 percentage of participants
|
33.3 percentage of participants
|
41.7 percentage of participants
|
68.4 percentage of participants
|
SECONDARY outcome
Timeframe: All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 4
|
10.9 percentage of participants
|
18.4 percentage of participants
|
20.0 percentage of participants
|
27.3 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 13
|
26.7 percentage of participants
|
27.6 percentage of participants
|
12.9 percentage of participants
|
36.8 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 1
|
3.7 percentage of participants
|
2.1 percentage of participants
|
6.0 percentage of participants
|
3.6 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 2
|
5.5 percentage of participants
|
12.2 percentage of participants
|
6.0 percentage of participants
|
12.7 percentage of participants
|
36.5 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 6
|
16.4 percentage of participants
|
18.4 percentage of participants
|
18.0 percentage of participants
|
38.2 percentage of participants
|
68.5 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 8
|
20.0 percentage of participants
|
22.4 percentage of participants
|
22.0 percentage of participants
|
40.0 percentage of participants
|
73.6 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 12
|
15.4 percentage of participants
|
17.4 percentage of participants
|
13.3 percentage of participants
|
40.7 percentage of participants
|
64.6 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 14
|
31.3 percentage of participants
|
25.0 percentage of participants
|
6.9 percentage of participants
|
35.0 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Week 16
|
32.1 percentage of participants
|
38.5 percentage of participants
|
3.7 percentage of participants
|
25.0 percentage of participants
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 8
|
5.5 percentage of participants
|
12.2 percentage of participants
|
8.0 percentage of participants
|
23.6 percentage of participants
|
43.4 percentage of participants
|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 13
|
10.0 percentage of participants
|
13.8 percentage of participants
|
3.2 percentage of participants
|
23.7 percentage of participants
|
31.1 percentage of participants
|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 1
|
0.0 percentage of participants
|
2.1 percentage of participants
|
4.0 percentage of participants
|
0.0 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 2
|
0.0 percentage of participants
|
6.1 percentage of participants
|
4.0 percentage of participants
|
5.5 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 4
|
1.8 percentage of participants
|
8.2 percentage of participants
|
8.0 percentage of participants
|
10.9 percentage of participants
|
38.9 percentage of participants
|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 6
|
7.3 percentage of participants
|
14.3 percentage of participants
|
14.0 percentage of participants
|
16.4 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 12
|
9.6 percentage of participants
|
10.9 percentage of participants
|
0.0 percentage of participants
|
25.9 percentage of participants
|
52.1 percentage of participants
|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 14
|
15.6 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
17.5 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Week 16
|
14.3 percentage of participants
|
23.1 percentage of participants
|
3.7 percentage of participants
|
8.3 percentage of participants
|
10.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 1
|
-0.06 percentage of BSA
Standard Deviation 6.699
|
-3.76 percentage of BSA
Standard Deviation 13.940
|
-2.45 percentage of BSA
Standard Deviation 7.017
|
-4.63 percentage of BSA
Standard Deviation 12.144
|
-10.86 percentage of BSA
Standard Deviation 15.690
|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 4
|
-6.34 percentage of BSA
Standard Deviation 16.138
|
-8.93 percentage of BSA
Standard Deviation 15.960
|
-9.59 percentage of BSA
Standard Deviation 14.845
|
-17.77 percentage of BSA
Standard Deviation 19.956
|
-28.55 percentage of BSA
Standard Deviation 20.447
|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 6
|
-10.79 percentage of BSA
Standard Deviation 16.413
|
-11.80 percentage of BSA
Standard Deviation 22.324
|
-10.71 percentage of BSA
Standard Deviation 15.007
|
-18.80 percentage of BSA
Standard Deviation 23.387
|
-30.51 percentage of BSA
Standard Deviation 20.853
|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 16
|
-8.09 percentage of BSA
Standard Deviation 15.797
|
-14.64 percentage of BSA
Standard Deviation 20.948
|
-3.52 percentage of BSA
Standard Deviation 20.967
|
-5.55 percentage of BSA
Standard Deviation 21.079
|
-17.88 percentage of BSA
Standard Deviation 17.059
|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 2
|
-5.43 percentage of BSA
Standard Deviation 10.030
|
-4.84 percentage of BSA
Standard Deviation 16.179
|
-6.51 percentage of BSA
Standard Deviation 10.485
|
-10.80 percentage of BSA
Standard Deviation 16.432
|
-21.30 percentage of BSA
Standard Deviation 19.285
|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 8
|
-9.71 percentage of BSA
Standard Deviation 17.837
|
-12.98 percentage of BSA
Standard Deviation 25.552
|
-10.79 percentage of BSA
Standard Deviation 19.259
|
-19.41 percentage of BSA
Standard Deviation 23.596
|
-29.98 percentage of BSA
Standard Deviation 20.864
|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 12
|
-13.82 percentage of BSA
Standard Deviation 22.348
|
-11.59 percentage of BSA
Standard Deviation 27.112
|
-9.37 percentage of BSA
Standard Deviation 18.783
|
-22.21 percentage of BSA
Standard Deviation 22.199
|
-27.72 percentage of BSA
Standard Deviation 18.361
|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 13
|
-7.90 percentage of BSA
Standard Deviation 18.233
|
-11.07 percentage of BSA
Standard Deviation 25.457
|
-7.79 percentage of BSA
Standard Deviation 17.469
|
-17.88 percentage of BSA
Standard Deviation 20.905
|
-22.61 percentage of BSA
Standard Deviation 22.390
|
|
Change From Baseline in Affected BSA at All Scheduled Time Points
Week 14
|
-8.97 percentage of BSA
Standard Deviation 16.223
|
-10.46 percentage of BSA
Standard Deviation 26.130
|
-6.33 percentage of BSA
Standard Deviation 17.404
|
-12.75 percentage of BSA
Standard Deviation 22.492
|
-16.35 percentage of BSA
Standard Deviation 18.931
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 1
|
-7.910 units on a scale
Standard Deviation 12.4625
|
-5.000 units on a scale
Standard Deviation 13.3310
|
-8.388 units on a scale
Standard Deviation 14.6316
|
-12.024 units on a scale
Standard Deviation 12.4053
|
-21.326 units on a scale
Standard Deviation 15.8867
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 2
|
-10.905 units on a scale
Standard Deviation 15.4157
|
-8.795 units on a scale
Standard Deviation 16.3883
|
-13.266 units on a scale
Standard Deviation 14.5268
|
-20.286 units on a scale
Standard Deviation 15.2402
|
-32.152 units on a scale
Standard Deviation 14.4354
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 13
|
-16.603 units on a scale
Standard Deviation 21.3850
|
-16.895 units on a scale
Standard Deviation 22.1132
|
-15.023 units on a scale
Standard Deviation 16.1573
|
-24.261 units on a scale
Standard Deviation 19.4912
|
-29.884 units on a scale
Standard Deviation 19.1501
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 16
|
-19.408 units on a scale
Standard Deviation 22.1744
|
-18.925 units on a scale
Standard Deviation 21.5459
|
-12.716 units on a scale
Standard Deviation 15.9390
|
-17.753 units on a scale
Standard Deviation 19.1842
|
-21.024 units on a scale
Standard Deviation 18.1576
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 14
|
-17.987 units on a scale
Standard Deviation 22.0893
|
-15.842 units on a scale
Standard Deviation 19.5000
|
-12.768 units on a scale
Standard Deviation 13.6914
|
-20.211 units on a scale
Standard Deviation 20.2920
|
-21.292 units on a scale
Standard Deviation 17.7775
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 4
|
-14.555 units on a scale
Standard Deviation 16.6414
|
-14.116 units on a scale
Standard Deviation 19.1643
|
-15.496 units on a scale
Standard Deviation 16.4795
|
-28.058 units on a scale
Standard Deviation 16.6775
|
-39.567 units on a scale
Standard Deviation 14.7328
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 6
|
-19.527 units on a scale
Standard Deviation 16.7869
|
-16.667 units on a scale
Standard Deviation 21.8577
|
-19.930 units on a scale
Standard Deviation 17.5966
|
-29.729 units on a scale
Standard Deviation 21.6156
|
-41.458 units on a scale
Standard Deviation 14.3943
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 8
|
-19.052 units on a scale
Standard Deviation 18.5735
|
-18.853 units on a scale
Standard Deviation 21.7947
|
-19.534 units on a scale
Standard Deviation 18.7098
|
-30.148 units on a scale
Standard Deviation 20.7887
|
-42.604 units on a scale
Standard Deviation 13.9771
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Week 12
|
-18.647 units on a scale
Standard Deviation 20.0191
|
-17.986 units on a scale
Standard Deviation 23.1948
|
-21.211 units on a scale
Standard Deviation 17.6774
|
-33.145 units on a scale
Standard Deviation 21.4221
|
-41.384 units on a scale
Standard Deviation 15.4359
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 1
|
-11.547 percent change
Standard Deviation 19.7128
|
-7.287 percent change
Standard Deviation 20.6403
|
-13.068 percent change
Standard Deviation 21.0746
|
-19.185 percent change
Standard Deviation 20.0094
|
-34.660 percent change
Standard Deviation 25.0837
|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 2
|
-16.488 percent change
Standard Deviation 23.0011
|
-12.980 percent change
Standard Deviation 25.5198
|
-20.613 percent change
Standard Deviation 21.0283
|
-31.025 percent change
Standard Deviation 23.9881
|
-51.384 percent change
Standard Deviation 21.3581
|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 4
|
-22.476 percent change
Standard Deviation 26.5163
|
-20.751 percent change
Standard Deviation 29.0846
|
-24.866 percent change
Standard Deviation 25.3755
|
-43.846 percent change
Standard Deviation 26.2001
|
-63.970 percent change
Standard Deviation 21.6701
|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 6
|
-30.789 percent change
Standard Deviation 27.9424
|
-25.851 percent change
Standard Deviation 34.2950
|
-31.276 percent change
Standard Deviation 29.6517
|
-45.270 percent change
Standard Deviation 34.3893
|
-66.971 percent change
Standard Deviation 22.4343
|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 8
|
-29.624 percent change
Standard Deviation 30.5625
|
-28.599 percent change
Standard Deviation 33.1460
|
-30.480 percent change
Standard Deviation 29.4742
|
-46.187 percent change
Standard Deviation 32.7984
|
-69.736 percent change
Standard Deviation 21.4403
|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 12
|
-29.379 percent change
Standard Deviation 31.9081
|
-27.607 percent change
Standard Deviation 36.5015
|
-32.535 percent change
Standard Deviation 25.2711
|
-51.624 percent change
Standard Deviation 33.0106
|
-68.537 percent change
Standard Deviation 24.2392
|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 13
|
-26.794 percent change
Standard Deviation 34.3384
|
-26.905 percent change
Standard Deviation 34.1879
|
-24.232 percent change
Standard Deviation 26.2461
|
-38.193 percent change
Standard Deviation 32.3458
|
-48.428 percent change
Standard Deviation 30.1133
|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 14
|
-29.393 percent change
Standard Deviation 36.6642
|
-25.511 percent change
Standard Deviation 31.1985
|
-20.072 percent change
Standard Deviation 21.7399
|
-31.521 percent change
Standard Deviation 34.1268
|
-36.519 percent change
Standard Deviation 28.5404
|
|
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Week 16
|
-31.972 percent change
Standard Deviation 36.5058
|
-30.135 percent change
Standard Deviation 34.2361
|
-19.794 percent change
Standard Deviation 25.0550
|
-29.130 percent change
Standard Deviation 33.1868
|
-34.995 percent change
Standard Deviation 27.4996
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 1
|
3.7 percentage of participants
|
2.1 percentage of participants
|
6.0 percentage of participants
|
7.3 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 2
|
5.5 percentage of participants
|
10.2 percentage of participants
|
10.0 percentage of participants
|
18.2 percentage of participants
|
55.8 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 4
|
20.0 percentage of participants
|
12.2 percentage of participants
|
16.0 percentage of participants
|
43.6 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 6
|
21.8 percentage of participants
|
16.3 percentage of participants
|
26.0 percentage of participants
|
45.5 percentage of participants
|
74.1 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 8
|
23.6 percentage of participants
|
22.4 percentage of participants
|
30.0 percentage of participants
|
43.6 percentage of participants
|
73.6 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 12
|
19.2 percentage of participants
|
13.0 percentage of participants
|
15.6 percentage of participants
|
50.0 percentage of participants
|
72.9 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 13
|
26.7 percentage of participants
|
20.7 percentage of participants
|
16.1 percentage of participants
|
34.2 percentage of participants
|
48.9 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 14
|
31.3 percentage of participants
|
17.9 percentage of participants
|
3.4 percentage of participants
|
32.5 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Week 16
|
39.3 percentage of participants
|
30.8 percentage of participants
|
14.8 percentage of participants
|
25.0 percentage of participants
|
34.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 1
|
0.0 percentage of participants
|
2.1 percentage of participants
|
2.0 percentage of participants
|
1.8 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 2
|
0.0 percentage of participants
|
2.0 percentage of participants
|
2.0 percentage of participants
|
3.6 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 12
|
3.8 percentage of participants
|
10.9 percentage of participants
|
0.0 percentage of participants
|
18.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 4
|
1.8 percentage of participants
|
4.1 percentage of participants
|
4.0 percentage of participants
|
14.5 percentage of participants
|
27.8 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 6
|
5.5 percentage of participants
|
12.2 percentage of participants
|
4.0 percentage of participants
|
20.0 percentage of participants
|
37.0 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 8
|
3.6 percentage of participants
|
6.1 percentage of participants
|
2.0 percentage of participants
|
16.4 percentage of participants
|
35.8 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 13
|
13.3 percentage of participants
|
10.3 percentage of participants
|
0.0 percentage of participants
|
18.4 percentage of participants
|
15.6 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 14
|
15.6 percentage of participants
|
7.1 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Week 16
|
14.3 percentage of participants
|
11.5 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline till Week 16Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs)
|
32 participants
|
34 participants
|
34 participants
|
43 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
AEs of lipid profile
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
AEs of anemia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
AEs of neutropenia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
AEs of thrombocytopenia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
AEs of lymphopenia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
AEs of liver function tests
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
Week 16
|
11.1 percentage of participants
|
7.7 percentage of participants
|
0.0 percentage of participants
|
11.8 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
Week 1
|
0.0 percentage of participants
|
2.1 percentage of participants
|
4.1 percentage of participants
|
1.9 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
Week 2
|
5.6 percentage of participants
|
0.0 percentage of participants
|
6.1 percentage of participants
|
16.7 percentage of participants
|
32.7 percentage of participants
|
|
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
Week 4
|
3.8 percentage of participants
|
6.1 percentage of participants
|
8.2 percentage of participants
|
22.2 percentage of participants
|
54.7 percentage of participants
|
|
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
Week 6
|
3.8 percentage of participants
|
10.2 percentage of participants
|
8.2 percentage of participants
|
22.2 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
Week 8
|
1.9 percentage of participants
|
6.1 percentage of participants
|
6.1 percentage of participants
|
24.1 percentage of participants
|
56.6 percentage of participants
|
|
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
Week 12
|
7.4 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
25.9 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
Week 14
|
3.2 percentage of participants
|
10.3 percentage of participants
|
0.0 percentage of participants
|
15.8 percentage of participants
|
15.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Week 1
|
-1.4 units on a scale
Standard Deviation 6.04
|
-1.4 units on a scale
Standard Deviation 5.66
|
-3.4 units on a scale
Standard Deviation 6.28
|
-5.1 units on a scale
Standard Deviation 5.40
|
-6.3 units on a scale
Standard Deviation 5.55
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Week 2
|
-2.3 units on a scale
Standard Deviation 5.42
|
-1.9 units on a scale
Standard Deviation 6.58
|
-5.0 units on a scale
Standard Deviation 5.55
|
-7.5 units on a scale
Standard Deviation 6.39
|
-8.6 units on a scale
Standard Deviation 6.46
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Week 4
|
-2.6 units on a scale
Standard Deviation 6.77
|
-3.7 units on a scale
Standard Deviation 7.33
|
-4.7 units on a scale
Standard Deviation 5.62
|
-8.2 units on a scale
Standard Deviation 7.48
|
-9.7 units on a scale
Standard Deviation 6.82
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Week 6
|
-4.2 units on a scale
Standard Deviation 6.01
|
-4.6 units on a scale
Standard Deviation 7.30
|
-4.1 units on a scale
Standard Deviation 7.75
|
-9.1 units on a scale
Standard Deviation 6.75
|
-10.2 units on a scale
Standard Deviation 6.72
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Week 8
|
-3.7 units on a scale
Standard Deviation 7.67
|
-5.6 units on a scale
Standard Deviation 8.44
|
-4.8 units on a scale
Standard Deviation 8.52
|
-9.2 units on a scale
Standard Deviation 7.95
|
-9.8 units on a scale
Standard Deviation 7.10
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Week 12
|
-4.6 units on a scale
Standard Deviation 8.49
|
-4.5 units on a scale
Standard Deviation 8.90
|
-5.2 units on a scale
Standard Deviation 7.30
|
-9.8 units on a scale
Standard Deviation 8.18
|
-9.5 units on a scale
Standard Deviation 7.28
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Week 14
|
-3.1 units on a scale
Standard Deviation 8.24
|
-3.9 units on a scale
Standard Deviation 7.62
|
-3.6 units on a scale
Standard Deviation 6.60
|
-6.2 units on a scale
Standard Deviation 7.87
|
-4.4 units on a scale
Standard Deviation 8.78
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Week 16
|
-4.5 units on a scale
Standard Deviation 7.95
|
-4.5 units on a scale
Standard Deviation 7.14
|
-3.5 units on a scale
Standard Deviation 7.17
|
-4.6 units on a scale
Standard Deviation 7.62
|
-3.6 units on a scale
Standard Deviation 7.39
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Week 16
|
-3.0 units on a scale
Standard Deviation 7.76
|
-3.0 units on a scale
Standard Deviation 7.67
|
-2.2 units on a scale
Standard Deviation 6.80
|
-4.3 units on a scale
Standard Deviation 6.20
|
-5.9 units on a scale
Standard Deviation 5.93
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Week 1
|
-1.1 units on a scale
Standard Deviation 3.59
|
-0.6 units on a scale
Standard Deviation 4.17
|
-2.1 units on a scale
Standard Deviation 5.83
|
-3.9 units on a scale
Standard Deviation 4.67
|
-9.2 units on a scale
Standard Deviation 5.77
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Week 2
|
-2.2 units on a scale
Standard Deviation 4.20
|
-1.9 units on a scale
Standard Deviation 6.13
|
-4.1 units on a scale
Standard Deviation 6.04
|
-7.2 units on a scale
Standard Deviation 6.79
|
-11.9 units on a scale
Standard Deviation 5.95
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Week 4
|
-2.2 units on a scale
Standard Deviation 6.05
|
-3.6 units on a scale
Standard Deviation 6.35
|
-4.3 units on a scale
Standard Deviation 5.69
|
-8.7 units on a scale
Standard Deviation 8.30
|
-14.6 units on a scale
Standard Deviation 6.20
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Week 6
|
-3.5 units on a scale
Standard Deviation 5.24
|
-4.3 units on a scale
Standard Deviation 7.63
|
-3.9 units on a scale
Standard Deviation 7.43
|
-10.4 units on a scale
Standard Deviation 8.17
|
-15.0 units on a scale
Standard Deviation 5.92
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Week 8
|
-2.3 units on a scale
Standard Deviation 5.91
|
-4.3 units on a scale
Standard Deviation 8.94
|
-5.4 units on a scale
Standard Deviation 8.05
|
-10.6 units on a scale
Standard Deviation 8.47
|
-15.2 units on a scale
Standard Deviation 6.15
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Week 12
|
-3.8 units on a scale
Standard Deviation 8.21
|
-4.7 units on a scale
Standard Deviation 8.83
|
-5.3 units on a scale
Standard Deviation 7.60
|
-11.4 units on a scale
Standard Deviation 8.08
|
-15.1 units on a scale
Standard Deviation 6.99
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Week 14
|
-2.2 units on a scale
Standard Deviation 6.45
|
-3.9 units on a scale
Standard Deviation 8.04
|
-2.7 units on a scale
Standard Deviation 6.05
|
-6.3 units on a scale
Standard Deviation 7.12
|
-6.2 units on a scale
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16Population: "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 Participants
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 Participants
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 Participants
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 Participants
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Depression score Week 1
|
-0.5 units on a scale
Standard Deviation 2.71
|
0.0 units on a scale
Standard Deviation 2.38
|
-0.6 units on a scale
Standard Deviation 2.49
|
-0.9 units on a scale
Standard Deviation 2.94
|
-1.0 units on a scale
Standard Deviation 2.16
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Depression score Week 2
|
-0.5 units on a scale
Standard Deviation 2.78
|
0.4 units on a scale
Standard Deviation 2.99
|
-1.1 units on a scale
Standard Deviation 1.85
|
-1.2 units on a scale
Standard Deviation 2.93
|
-1.8 units on a scale
Standard Deviation 2.66
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Depression score Week 4
|
-0.5 units on a scale
Standard Deviation 3.00
|
-0.4 units on a scale
Standard Deviation 3.26
|
-0.8 units on a scale
Standard Deviation 2.05
|
-1.5 units on a scale
Standard Deviation 3.35
|
-2.1 units on a scale
Standard Deviation 3.30
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Depression score Week 8
|
-0.7 units on a scale
Standard Deviation 3.31
|
-1.3 units on a scale
Standard Deviation 3.76
|
-0.9 units on a scale
Standard Deviation 2.84
|
-2.1 units on a scale
Standard Deviation 3.35
|
-1.7 units on a scale
Standard Deviation 3.08
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Depression score Week 12
|
-0.9 units on a scale
Standard Deviation 3.96
|
-0.9 units on a scale
Standard Deviation 3.65
|
-0.5 units on a scale
Standard Deviation 2.83
|
-2.4 units on a scale
Standard Deviation 3.74
|
-1.8 units on a scale
Standard Deviation 3.90
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Depression score Week 14
|
0.1 units on a scale
Standard Deviation 3.41
|
-1.2 units on a scale
Standard Deviation 3.50
|
-0.9 units on a scale
Standard Deviation 1.53
|
-1.7 units on a scale
Standard Deviation 4.31
|
-0.1 units on a scale
Standard Deviation 4.18
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Depression score Week 16
|
-0.7 units on a scale
Standard Deviation 3.18
|
-1.1 units on a scale
Standard Deviation 3.59
|
-1.0 units on a scale
Standard Deviation 1.85
|
-1.4 units on a scale
Standard Deviation 3.93
|
-0.1 units on a scale
Standard Deviation 3.57
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Anxiety score Week 1
|
-1.0 units on a scale
Standard Deviation 2.66
|
0.2 units on a scale
Standard Deviation 2.41
|
-0.2 units on a scale
Standard Deviation 2.49
|
-1.1 units on a scale
Standard Deviation 2.26
|
-1.2 units on a scale
Standard Deviation 2.71
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Anxiety score Week 2
|
-1.5 units on a scale
Standard Deviation 2.87
|
-0.4 units on a scale
Standard Deviation 2.56
|
-0.9 units on a scale
Standard Deviation 2.88
|
-1.7 units on a scale
Standard Deviation 2.81
|
-2.4 units on a scale
Standard Deviation 3.15
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Anxiety score Week 4
|
-1.6 units on a scale
Standard Deviation 3.18
|
-1.0 units on a scale
Standard Deviation 2.80
|
-0.7 units on a scale
Standard Deviation 2.69
|
-1.7 units on a scale
Standard Deviation 2.95
|
-2.4 units on a scale
Standard Deviation 4.04
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Anxiety score Week 8
|
-1.7 units on a scale
Standard Deviation 2.33
|
-1.6 units on a scale
Standard Deviation 2.67
|
-1.4 units on a scale
Standard Deviation 3.21
|
-2.7 units on a scale
Standard Deviation 3.44
|
-2.5 units on a scale
Standard Deviation 3.31
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Anxiety score Week 12
|
-2.6 units on a scale
Standard Deviation 3.01
|
-1.5 units on a scale
Standard Deviation 2.85
|
-1.0 units on a scale
Standard Deviation 3.43
|
-2.8 units on a scale
Standard Deviation 3.71
|
-2.5 units on a scale
Standard Deviation 3.51
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Anxiety score Week 14
|
-2.3 units on a scale
Standard Deviation 3.43
|
-1.5 units on a scale
Standard Deviation 3.17
|
-1.4 units on a scale
Standard Deviation 2.96
|
-2.0 units on a scale
Standard Deviation 3.49
|
-1.5 units on a scale
Standard Deviation 3.93
|
|
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Anxiety score Week 16
|
-2.9 units on a scale
Standard Deviation 3.75
|
-2.2 units on a scale
Standard Deviation 3.38
|
-0.7 units on a scale
Standard Deviation 3.27
|
-1.4 units on a scale
Standard Deviation 3.85
|
-1.5 units on a scale
Standard Deviation 3.10
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
PF-04965842 10mg QD
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
PF-04965842 30mg QD
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
PF-04965842 100mg QD
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
PF-04965842 200mg QD
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=56 participants at risk
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 participants at risk
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 participants at risk
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 participants at risk
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 participants at risk
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.8%
1/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.0%
1/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.0%
1/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.8%
1/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Placebo
n=56 participants at risk
Participants received matching placebo tablets for a 12-week double-blind treatment period.
|
PF-04965842 10mg QD
n=49 participants at risk
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 30mg QD
n=51 participants at risk
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 100mg QD
n=56 participants at risk
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
|
PF-04965842 200mg QD
n=55 participants at risk
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.1%
3/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.0%
1/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
5/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.1%
3/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
3/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.8%
1/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.5%
8/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
5/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.1%
3/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.8%
5/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.4%
3/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
5/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.9%
5/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.2%
5/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
6/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.9%
10/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.7%
7/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.0%
1/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.5%
3/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
3.6%
2/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.1%
2/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.8%
5/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.9%
5/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.3%
4/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
10.7%
6/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.3%
8/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
9/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
7/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.7%
7/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/49 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.4%
3/56 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/55 • Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER