Trial Outcomes & Findings for Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis (NCT NCT03903822)

NCT ID: NCT03903822

Last Updated: 2021-03-29

Results Overview

EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

292 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2021-03-29

Participant Flow

Participant milestones

Participant milestones
Measure
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible atopic dermatitis (AD) areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 percent (%) cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Treatment Phase (6 Weeks)
STARTED
37
37
36
37
36
36
36
37
Treatment Phase (6 Weeks)
COMPLETED
28
27
33
32
31
25
31
33
Treatment Phase (6 Weeks)
NOT COMPLETED
9
10
3
5
5
11
5
4
Follow up Phase (4 Weeks)
STARTED
37
37
36
37
36
36
36
37
Follow up Phase (4 Weeks)
COMPLETED
29
29
32
33
32
28
31
31
Follow up Phase (4 Weeks)
NOT COMPLETED
8
8
4
4
4
8
5
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible atopic dermatitis (AD) areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 percent (%) cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Treatment Phase (6 Weeks)
Adverse Event
3
3
1
1
1
6
1
0
Treatment Phase (6 Weeks)
Lack of Efficacy
0
0
0
0
1
1
0
0
Treatment Phase (6 Weeks)
Lost to Follow-up
0
0
0
0
0
0
1
1
Treatment Phase (6 Weeks)
Physician Decision
0
2
0
0
0
0
0
0
Treatment Phase (6 Weeks)
Pregnancy
0
0
0
1
1
0
0
0
Treatment Phase (6 Weeks)
Protocol Violation
0
0
0
1
0
0
0
0
Treatment Phase (6 Weeks)
Withdrawal by Subject
2
4
2
2
1
2
3
3
Treatment Phase (6 Weeks)
Refused Further Treatment
2
0
0
0
0
1
0
0
Treatment Phase (6 Weeks)
Other
2
1
0
0
1
1
0
0
Follow up Phase (4 Weeks)
Adverse Event
3
2
1
1
0
5
1
0
Follow up Phase (4 Weeks)
Lack of Efficacy
0
0
0
0
1
0
0
0
Follow up Phase (4 Weeks)
Lost to Follow-up
2
0
0
0
0
0
1
3
Follow up Phase (4 Weeks)
Pregnancy
0
0
0
1
1
0
0
0
Follow up Phase (4 Weeks)
Withdrawal by Subject
2
5
3
2
2
2
3
3
Follow up Phase (4 Weeks)
Refused Further Study Procedures
0
0
0
0
0
1
0
0
Follow up Phase (4 Weeks)
Other
1
1
0
0
0
0
0
0

Baseline Characteristics

Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Total
n=292 Participants
Total of all reporting groups
Age, Continuous
39.1 Years
STANDARD_DEVIATION 16.80 • n=5 Participants
40.8 Years
STANDARD_DEVIATION 15.35 • n=7 Participants
43.4 Years
STANDARD_DEVIATION 16.43 • n=5 Participants
38.4 Years
STANDARD_DEVIATION 12.90 • n=4 Participants
40.5 Years
STANDARD_DEVIATION 12.30 • n=21 Participants
42.3 Years
STANDARD_DEVIATION 18.18 • n=8 Participants
39.4 Years
STANDARD_DEVIATION 17.27 • n=8 Participants
38.1 Years
STANDARD_DEVIATION 15.34 • n=24 Participants
40.2 Years
STANDARD_DEVIATION 15.59 • n=42 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
19 Participants
n=7 Participants
24 Participants
n=5 Participants
23 Participants
n=4 Participants
15 Participants
n=21 Participants
19 Participants
n=8 Participants
16 Participants
n=8 Participants
20 Participants
n=24 Participants
156 Participants
n=42 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
18 Participants
n=7 Participants
12 Participants
n=5 Participants
14 Participants
n=4 Participants
21 Participants
n=21 Participants
17 Participants
n=8 Participants
20 Participants
n=8 Participants
17 Participants
n=24 Participants
136 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
0 Participants
n=8 Participants
4 Participants
n=24 Participants
13 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
37 Participants
n=5 Participants
37 Participants
n=7 Participants
32 Participants
n=5 Participants
35 Participants
n=4 Participants
35 Participants
n=21 Participants
33 Participants
n=8 Participants
35 Participants
n=8 Participants
33 Participants
n=24 Participants
277 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
0 Participants
n=24 Participants
2 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
8 Participants
n=7 Participants
4 Participants
n=5 Participants
8 Participants
n=4 Participants
10 Participants
n=21 Participants
9 Participants
n=8 Participants
9 Participants
n=8 Participants
7 Participants
n=24 Participants
59 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
2 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=5 Participants
7 Participants
n=7 Participants
9 Participants
n=5 Participants
6 Participants
n=4 Participants
4 Participants
n=21 Participants
6 Participants
n=8 Participants
5 Participants
n=8 Participants
6 Participants
n=24 Participants
51 Participants
n=42 Participants
Race (NIH/OMB)
White
24 Participants
n=5 Participants
22 Participants
n=7 Participants
21 Participants
n=5 Participants
20 Participants
n=4 Participants
21 Participants
n=21 Participants
20 Participants
n=8 Participants
22 Participants
n=8 Participants
24 Participants
n=24 Participants
174 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
5 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method assuming responses are similar to the corresponding vehicle arm under the MAR assumption

EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
-44.4 Percent change
Interval -57.3 to -31.6
-58.3 Percent change
Interval -71.2 to -45.5
-64.6 Percent change
Interval -77.1 to -52.1
-70.1 Percent change
Interval -82.1 to -58.0
-67.9 Percent change
Interval -80.6 to -55.3
-47.6 Percent change
Interval -57.5 to -37.7
-58.6 Percent change
Interval -67.5 to -49.7
-75.0 Percent change
Interval -83.8 to -66.2

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.

IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation
10.8 Percentage of participants
Interval 4.8 to 22.2
29.7 Percentage of participants
Interval 18.5 to 43.3
33.3 Percentage of participants
Interval 21.3 to 47.0
40.5 Percentage of participants
Interval 28.0 to 54.4
44.4 Percentage of participants
Interval 30.2 to 59.1
13.9 Percentage of participants
Interval 6.9 to 25.4
33.3 Percentage of participants
Interval 21.3 to 47.0
27.0 Percentage of participants
Interval 15.5 to 40.2

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method assuming responses are similar to the corresponding vehicle arm under the MAR assumption

EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
-3.2 Units on a scale
Interval -4.1 to -2.3
-4.5 Units on a scale
Interval -5.4 to -3.6
-4.6 Units on a scale
Interval -5.5 to -3.7
-4.8 Units on a scale
Interval -5.7 to -3.9
-5.5 Units on a scale
Interval -6.4 to -4.7
-3.6 Units on a scale
Interval -4.3 to -3.0
-4.4 Units on a scale
Interval -5.0 to -3.8
-5.3 Units on a scale
Interval -5.9 to -4.7

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4 and 6

Population: Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. NRI method: participants with missing values were considered to be non-responders.

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 3
21.6 Percentage of participants
Interval 11.2 to 34.3
38.9 Percentage of participants
Interval 25.4 to 53.0
48.6 Percentage of participants
Interval 33.8 to 63.5
59.5 Percentage of participants
Interval 45.6 to 72.0
58.3 Percentage of participants
Interval 44.0 to 71.0
33.3 Percentage of participants
Interval 21.3 to 47.0
51.4 Percentage of participants
Interval 36.5 to 66.2
57.1 Percentage of participants
Interval 41.9 to 70.0
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 4
35.1 Percentage of participants
Interval 22.2 to 49.3
38.9 Percentage of participants
Interval 25.4 to 53.0
51.4 Percentage of participants
Interval 36.5 to 66.2
62.2 Percentage of participants
Interval 48.0 to 75.2
58.3 Percentage of participants
Interval 44.0 to 71.0
30.6 Percentage of participants
Interval 18.9 to 44.0
60.0 Percentage of participants
Interval 44.8 to 74.0
60.0 Percentage of participants
Interval 44.8 to 74.0
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 6
40.5 Percentage of participants
Interval 28.0 to 54.4
41.7 Percentage of participants
Interval 29.0 to 56.0
51.4 Percentage of participants
Interval 36.5 to 66.2
56.8 Percentage of participants
Interval 43.2 to 70.7
61.1 Percentage of participants
Interval 47.0 to 74.6
30.6 Percentage of participants
Interval 18.9 to 44.0
60.0 Percentage of participants
Interval 44.8 to 74.0
60.0 Percentage of participants
Interval 44.8 to 74.0
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 1
16.2 Percentage of participants
Interval 7.3 to 29.3
16.7 Percentage of participants
Interval 7.5 to 30.2
20.0 Percentage of participants
Interval 11.0 to 33.8
29.7 Percentage of participants
Interval 18.5 to 43.3
44.4 Percentage of participants
Interval 30.2 to 59.1
13.9 Percentage of participants
Interval 6.9 to 25.4
28.6 Percentage of participants
Interval 16.4 to 41.9
25.7 Percentage of participants
Interval 15.4 to 39.2
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 2
24.3 Percentage of participants
Interval 14.5 to 37.0
30.6 Percentage of participants
Interval 18.9 to 44.0
42.9 Percentage of participants
Interval 30.0 to 58.1
48.6 Percentage of participants
Interval 34.3 to 63.0
61.1 Percentage of participants
Interval 47.0 to 74.6
25.0 Percentage of participants
Interval 14.9 to 38.0
45.7 Percentage of participants
Interval 31.7 to 60.8
37.1 Percentage of participants
Interval 23.6 to 52.2

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. NRI method: participants with missing values were considered to be non-responders.

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=33 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=30 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=32 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=31 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=28 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=30 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=30 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=27 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
At Week 1
0.0 Percentage of participants
Interval 0.0 to 8.2
3.3 Percentage of participants
Interval 0.4 to 14.0
3.1 Percentage of participants
Interval 0.3 to 13.1
16.1 Percentage of participants
Interval 8.1 to 29.7
10.7 Percentage of participants
Interval 4.0 to 23.8
3.3 Percentage of participants
Interval 0.4 to 14.0
3.3 Percentage of participants
Interval 0.4 to 14.0
11.1 Percentage of participants
Interval 4.2 to 24.8
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
At Week 2
9.1 Percentage of participants
Interval 3.4 to 20.2
10.0 Percentage of participants
Interval 3.7 to 22.1
9.4 Percentage of participants
Interval 3.5 to 20.7
19.4 Percentage of participants
Interval 8.8 to 32.7
25.0 Percentage of participants
Interval 13.9 to 40.0
10.0 Percentage of participants
Interval 3.7 to 22.1
13.3 Percentage of participants
Interval 5.9 to 27.9
33.3 Percentage of participants
Interval 20.4 to 50.0
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
At Week 3
12.1 Percentage of participants
Interval 5.4 to 25.1
23.3 Percentage of participants
Interval 12.9 to 37.6
15.6 Percentage of participants
Interval 7.8 to 28.7
32.3 Percentage of participants
Interval 18.7 to 48.2
32.1 Percentage of participants
Interval 19.7 to 47.3
10.0 Percentage of participants
Interval 3.7 to 22.1
20.0 Percentage of participants
Interval 9.1 to 33.9
37.0 Percentage of participants
Interval 22.1 to 54.7
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
At Week 4
18.2 Percentage of participants
Interval 8.2 to 31.3
26.7 Percentage of participants
Interval 14.0 to 41.6
28.1 Percentage of participants
Interval 17.0 to 43.3
35.5 Percentage of participants
Interval 21.3 to 51.8
50.0 Percentage of participants
Interval 33.3 to 66.7
10.0 Percentage of participants
Interval 3.7 to 22.1
30.0 Percentage of participants
Interval 18.2 to 45.5
37.0 Percentage of participants
Interval 22.1 to 54.7
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
At Week 6
18.2 Percentage of participants
Interval 8.2 to 31.3
30.0 Percentage of participants
Interval 18.2 to 45.5
34.4 Percentage of participants
Interval 20.7 to 50.0
45.2 Percentage of participants
Interval 29.7 to 60.1
50.0 Percentage of participants
Interval 33.3 to 66.7
16.7 Percentage of participants
Interval 8.3 to 30.8
33.3 Percentage of participants
Interval 19.3 to 49.2
40.7 Percentage of participants
Interval 24.8 to 58.3
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
At Follow-up visit
9.1 Percentage of participants
Interval 3.4 to 20.2
30.0 Percentage of participants
Interval 18.2 to 45.5
21.9 Percentage of participants
Interval 12.1 to 36.2
19.4 Percentage of participants
Interval 8.8 to 32.7
21.4 Percentage of participants
Interval 9.8 to 36.6
20.0 Percentage of participants
Interval 9.1 to 33.9
20.0 Percentage of participants
Interval 9.1 to 33.9
7.4 Percentage of participants
Interval 2.0 to 20.4

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
At Week 1
-2.4 Percent change
Interval -12.2 to 7.4
-2.9 Percent change
Interval -12.5 to 6.8
-16.2 Percent change
Interval -26.2 to -6.2
-19.9 Percent change
Interval -29.6 to -10.2
-23.0 Percent change
Interval -32.8 to -13.1
8.5 Percent change
Interval -8.3 to 25.3
-16.5 Percent change
Interval -32.9 to -0.1
-17.0 Percent change
Interval -33.5 to -0.5
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
At Week 2
-15.3 Percent change
Interval -28.0 to -2.6
-7.2 Percent change
Interval -20.2 to 5.8
-38.1 Percent change
Interval -51.0 to -25.2
-43.6 Percent change
Interval -56.5 to -30.8
-39.0 Percent change
Interval -52.1 to -26.0
-2.5 Percent change
Interval -14.0 to 9.1
-34.2 Percent change
Interval -45.4 to -22.9
-43.1 Percent change
Interval -54.5 to -31.6
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
At Week 3
-17.1 Percent change
Interval -31.0 to -3.1
-13.1 Percent change
Interval -27.4 to 1.1
-50.6 Percent change
Interval -64.4 to -36.7
-55.9 Percent change
Interval -69.7 to -42.0
-49.2 Percent change
Interval -63.2 to -35.1
-25.2 Percent change
Interval -39.2 to -11.1
-39.8 Percent change
Interval -53.0 to -26.6
-44.0 Percent change
Interval -57.1 to -30.9
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
At Week 4
-25.9 Percent change
Interval -39.8 to -12.0
-20.1 Percent change
Interval -34.4 to -5.7
-55.8 Percent change
Interval -69.5 to -42.1
-57.9 Percent change
Interval -71.7 to -44.0
-56.7 Percent change
Interval -70.8 to -42.7
-34.7 Percent change
Interval -46.1 to -23.3
-46.4 Percent change
Interval -56.9 to -35.9
-57.7 Percent change
Interval -68.2 to -47.2
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
At Week 6
-21.6 Percent change
Interval -38.0 to -5.3
-39.4 Percent change
Interval -56.1 to -22.7
-59.4 Percent change
Interval -75.4 to -43.5
-63.6 Percent change
Interval -79.5 to -47.6
-60.3 Percent change
Interval -76.4 to -44.1
-31.2 Percent change
Interval -42.5 to -20.0
-48.9 Percent change
Interval -59.3 to -38.6
-65.0 Percent change
Interval -75.3 to -54.7
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
At Follow-up visit
-23.6 Percent change
Interval -39.5 to -7.6
-24.5 Percent change
Interval -41.0 to -8.0
-42.7 Percent change
Interval -58.1 to -27.2
-37.0 Percent change
Interval -52.6 to -21.4
-55.2 Percent change
Interval -71.8 to -38.6
-26.3 Percent change
Interval -47.5 to -5.2
-31.6 Percent change
Interval -52.0 to -11.3
-24.6 Percent change
Interval -45.2 to -4.1

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4 and 6

Population: Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. NRI method: participants with missing values were considered to be non-responders.

EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 1
5.4 Percentage of participants
Interval 1.4 to 15.5
0.0 Percentage of participants
Interval 0.0 to 7.3
19.4 Percentage of participants
Interval 10.7 to 32.8
5.4 Percentage of participants
Interval 1.4 to 15.5
16.7 Percentage of participants
Interval 7.5 to 30.2
0.0 Percentage of participants
Interval 0.0 to 7.5
13.9 Percentage of participants
Interval 6.9 to 25.4
21.6 Percentage of participants
Interval 11.2 to 34.3
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 2
8.1 Percentage of participants
Interval 3.0 to 18.5
10.8 Percentage of participants
Interval 4.8 to 22.2
27.8 Percentage of participants
Interval 15.9 to 40.9
24.3 Percentage of participants
Interval 14.5 to 37.0
38.9 Percentage of participants
Interval 25.4 to 53.0
13.9 Percentage of participants
Interval 6.9 to 25.4
25.0 Percentage of participants
Interval 14.9 to 38.0
32.4 Percentage of participants
Interval 20.6 to 46.4
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 3
5.4 Percentage of participants
Interval 1.4 to 15.5
16.2 Percentage of participants
Interval 7.3 to 29.3
36.1 Percentage of participants
Interval 22.9 to 50.0
43.2 Percentage of participants
Interval 29.3 to 56.8
41.7 Percentage of participants
Interval 29.0 to 56.0
19.4 Percentage of participants
Interval 10.7 to 32.8
19.4 Percentage of participants
Interval 10.7 to 32.8
43.2 Percentage of participants
Interval 29.3 to 56.8
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 4
24.3 Percentage of participants
Interval 14.5 to 37.0
21.6 Percentage of participants
Interval 11.2 to 34.3
38.9 Percentage of participants
Interval 25.4 to 53.0
43.2 Percentage of participants
Interval 29.3 to 56.8
50.0 Percentage of participants
Interval 35.3 to 64.7
22.2 Percentage of participants
Interval 11.6 to 35.3
36.1 Percentage of participants
Interval 22.9 to 50.0
48.6 Percentage of participants
Interval 34.3 to 63.0
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
At Week 6
35.1 Percentage of participants
Interval 22.2 to 49.3
32.4 Percentage of participants
Interval 20.6 to 46.4
52.8 Percentage of participants
Interval 38.0 to 67.2
54.1 Percentage of participants
Interval 40.2 to 68.2
50.0 Percentage of participants
Interval 35.3 to 64.7
16.7 Percentage of participants
Interval 7.5 to 30.2
36.1 Percentage of participants
Interval 22.9 to 50.0
51.4 Percentage of participants
Interval 37.0 to 65.7

SECONDARY outcome

Timeframe: Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs
18 Participants
17 Participants
11 Participants
12 Participants
10 Participants
17 Participants
9 Participants
14 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of \>= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of \>=20mmHg decrease, c) supine DBP: less than (\<) 50 mmHg, d) supine DBP: change of \>= 20mmHg increase, e) supine DBP: change of \>= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: \<90 mmHg, b) sitting SBP: change of \>=30mmHg increase, c) sitting SBP: change of \>=30mmHg decrease, d) supine SBP: change of \>=30mmHg increase, e) supine SBP: change of \>=30mmHg decrease and f) Supine SBP: value \<90mmHg.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=21 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=20 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=25 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=18 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=21 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=19 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=22 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=22 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Number of Participants With Pre-defined Criteria For Vital Signs
Sitting SBP: change >= 30mmHg decrease
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Supine SBP: Change >= 30mmHg increase
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
1 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Supine SBP: Change >= 30mmHg decrease
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Supine SBP: Value <90mmHg
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Sitting SBP: change >= 30mmHg increase
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Sitting DBP: Change >= 20 mm Hg increase
0 Participants
0 Participants
1 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Sitting DBP: Change >= 20mmHg decrease
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Supine DBP: Value <50 mmHg
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Supine DBP: Change >= 20mmHg increase
0 Participants
1 Participants
1 Participants
2 Participants
1 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Supine DBP: Change >= 20mmHg decrease
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Pre-defined Criteria For Vital Signs
Sitting SBP: <90mmHg
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Hemoglobin (HGB),hematocrit,erythrocytes (ery.),HDL cholesterol (chl.)\<0.8\*lower limit of normal(LLN);reticulocytes (ret.), ret./ery. (%)\<0.5\*LLN,\>1.5\*upper limit of normal (ULN);ery. mean corpuscular (EMC) volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN;platelets\<0.5\*LLN,\>1.75\*ULN;leukocytes (leu.),glucose\<0.6\*LLN,\>1.5\*ULN;lymphocytes (lym.), lym./leu.(%), neutrophils (neu.), neu./leu. (%), protein,albumin \<0.8\*LLN,\>1.2\*ULN;basophils (bas.), bas./leu.(%), eosinophils (eos.), eos./leu., monocytes (mon.), mon./leu.(%), urate \>1.2\*ULN;bilirubin (total, direct, indirect)\>1.5\*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\>3.0\*ULN;urea nitrogen, creatinine, triglycerides, chl.\>1.3\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; creatine kinase \>2.0\*ULN;Urine: pH\<4.5,\>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase\>=1;ery., leu.\>= 20;hyaline casts\>1;bacteria\>20.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Number of Participants With Laboratory Abnormalities
26 Participants
22 Participants
23 Participants
22 Participants
16 Participants
21 Participants
24 Participants
24 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Clinically significant ECG criteria included PR interval: value greater than (\>) 280 millisecond (msec), percentage change greater than equal to (\>=) 25/50 percentage, QRS interval: value \>120 msec, percentage change \>= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30\<=change\<60.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=8 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=6 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=7 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=9 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=10 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=6 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=7 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=7 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
PR interval : value >280 msec
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
PR interval : %change>=25/50%
0 Participants
1 Participants
1 Participants
0 Participants
1 Participants
0 Participants
2 Participants
0 Participants
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
QRS interval: value >120 msec
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
QRS interval: %Change>=50%
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
QTCF: 450 msec
0 Participants
0 Participants
1 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
QTCF: 30<=Change<60
0 Participants
1 Participants
1 Participants
1 Participants
1 Participants
2 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=32 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=32 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=32 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=32 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=32 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at week 1
0.4 Units per liter
Standard Deviation 25.99
-7.4 Units per liter
Standard Deviation 30.20
-5.3 Units per liter
Standard Deviation 16.99
-9.3 Units per liter
Standard Deviation 22.65
-18.4 Units per liter
Standard Deviation 33.42
-8.0 Units per liter
Standard Deviation 34.51
-8.0 Units per liter
Standard Deviation 19.37
-4.3 Units per liter
Standard Deviation 29.08
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at week 2
-8.8 Units per liter
Standard Deviation 21.56
-7.8 Units per liter
Standard Deviation 27.99
-1.9 Units per liter
Standard Deviation 18.18
-8.8 Units per liter
Standard Deviation 23.70
-15.8 Units per liter
Standard Deviation 42.19
-0.3 Units per liter
Standard Deviation 22.81
-8.0 Units per liter
Standard Deviation 22.31
-4.9 Units per liter
Standard Deviation 24.49
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at week 4
-8.6 Units per liter
Standard Deviation 23.93
-5.4 Units per liter
Standard Deviation 22.87
-9.3 Units per liter
Standard Deviation 19.61
-12.1 Units per liter
Standard Deviation 28.54
-16.3 Units per liter
Standard Deviation 33.97
-1.0 Units per liter
Standard Deviation 29.29
-19.5 Units per liter
Standard Deviation 19.94
-3.7 Units per liter
Standard Deviation 24.96
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at week 6
-8.8 Units per liter
Standard Deviation 18.25
-8.1 Units per liter
Standard Deviation 32.02
-1.5 Units per liter
Standard Deviation 32.42
-6.4 Units per liter
Standard Deviation 28.53
-18.2 Units per liter
Standard Deviation 33.86
-9.7 Units per liter
Standard Deviation 20.68
-11.2 Units per liter
Standard Deviation 22.34
-7.0 Units per liter
Standard Deviation 24.65
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at follow-up visit
-12.3 Units per liter
Standard Deviation 24.82
-12.0 Units per liter
Standard Deviation 28.83
4.0 Units per liter
Standard Deviation 43.45
-2.7 Units per liter
Standard Deviation 26.27
-15.1 Units per liter
Standard Deviation 38.23
-11.3 Units per liter
Standard Deviation 29.39
-13.3 Units per liter
Standard Deviation 25.37
0.2 Units per liter
Standard Deviation 16.48

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Albumin:change at week 6
-0.08 Gram per deciliter
Standard Deviation 0.259
0.08 Gram per deciliter
Standard Deviation 0.245
-0.14 Gram per deciliter
Standard Deviation 0.333
-0.02 Gram per deciliter
Standard Deviation 0.269
-0.00 Gram per deciliter
Standard Deviation 0.218
-0.03 Gram per deciliter
Standard Deviation 0.252
-0.07 Gram per deciliter
Standard Deviation 0.244
-0.05 Gram per deciliter
Standard Deviation 0.227
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Protein: change at week 1
-0.01 Gram per deciliter
Standard Deviation 0.439
-0.04 Gram per deciliter
Standard Deviation 0.294
-0.14 Gram per deciliter
Standard Deviation 0.433
-0.04 Gram per deciliter
Standard Deviation 0.264
-0.03 Gram per deciliter
Standard Deviation 0.421
-0.10 Gram per deciliter
Standard Deviation 0.360
-0.01 Gram per deciliter
Standard Deviation 0.344
-0.02 Gram per deciliter
Standard Deviation 0.301
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Protein:change at week 2
-0.09 Gram per deciliter
Standard Deviation 0.383
0.03 Gram per deciliter
Standard Deviation 0.303
-0.18 Gram per deciliter
Standard Deviation 0.402
-0.01 Gram per deciliter
Standard Deviation 0.275
0.01 Gram per deciliter
Standard Deviation 0.561
0.02 Gram per deciliter
Standard Deviation 0.503
-0.04 Gram per deciliter
Standard Deviation 0.286
-0.10 Gram per deciliter
Standard Deviation 0.299
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Protein: change at week 4
-0.10 Gram per deciliter
Standard Deviation 0.380
0.07 Gram per deciliter
Standard Deviation 0.315
-0.08 Gram per deciliter
Standard Deviation 0.429
-0.03 Gram per deciliter
Standard Deviation 0.341
-0.04 Gram per deciliter
Standard Deviation 0.465
-0.18 Gram per deciliter
Standard Deviation 0.292
-0.15 Gram per deciliter
Standard Deviation 0.242
0.03 Gram per deciliter
Standard Deviation 0.280
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Protein: change at week 6
-0.13 Gram per deciliter
Standard Deviation 0.403
0.13 Gram per deciliter
Standard Deviation 0.379
-0.19 Gram per deciliter
Standard Deviation 0.452
0.01 Gram per deciliter
Standard Deviation 0.368
-0.03 Gram per deciliter
Standard Deviation 0.405
-0.10 Gram per deciliter
Standard Deviation 0.424
-0.09 Gram per deciliter
Standard Deviation 0.368
-0.09 Gram per deciliter
Standard Deviation 0.310
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Protein: change at follow-up visit
-0.07 Gram per deciliter
Standard Deviation 0.341
0.05 Gram per deciliter
Standard Deviation 0.457
-0.15 Gram per deciliter
Standard Deviation 0.481
-0.04 Gram per deciliter
Standard Deviation 0.404
0.03 Gram per deciliter
Standard Deviation 0.481
-0.18 Gram per deciliter
Standard Deviation 0.471
-0.09 Gram per deciliter
Standard Deviation 0.398
0.02 Gram per deciliter
Standard Deviation 0.299
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Albumin:change at week 1
-0.04 Gram per deciliter
Standard Deviation 0.269
-0.05 Gram per deciliter
Standard Deviation 0.205
-0.10 Gram per deciliter
Standard Deviation 0.283
-0.02 Gram per deciliter
Standard Deviation 0.177
0.00 Gram per deciliter
Standard Deviation 0.256
-0.05 Gram per deciliter
Standard Deviation 0.218
-0.03 Gram per deciliter
Standard Deviation 0.246
0.00 Gram per deciliter
Standard Deviation 0.169
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Albumin:change at week 2
-0.06 Gram per deciliter
Standard Deviation 0.235
0.02 Gram per deciliter
Standard Deviation 0.201
-0.10 Gram per deciliter
Standard Deviation 0.256
-0.02 Gram per deciliter
Standard Deviation 0.204
-0.01 Gram per deciliter
Standard Deviation 0.283
0.02 Gram per deciliter
Standard Deviation 0.266
-0.03 Gram per deciliter
Standard Deviation 0.174
-0.06 Gram per deciliter
Standard Deviation 0.202
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Albumin: change at week 4
-0.08 Gram per deciliter
Standard Deviation 0.245
0.07 Gram per deciliter
Standard Deviation 0.172
-0.08 Gram per deciliter
Standard Deviation 0.285
0.01 Gram per deciliter
Standard Deviation 0.239
0.04 Gram per deciliter
Standard Deviation 0.292
-0.10 Gram per deciliter
Standard Deviation 0.232
-0.08 Gram per deciliter
Standard Deviation 0.180
0.03 Gram per deciliter
Standard Deviation 0.224
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Albumin: change at follow-up visit
-0.06 Gram per deciliter
Standard Deviation 0.247
0.10 Gram per deciliter
Standard Deviation 0.260
-0.09 Gram per deciliter
Standard Deviation 0.277
-0.04 Gram per deciliter
Standard Deviation 0.295
-0.01 Gram per deciliter
Standard Deviation 0.346
-0.09 Gram per deciliter
Standard Deviation 0.262
-0.02 Gram per deciliter
Standard Deviation 0.211
0.06 Gram per deciliter
Standard Deviation 0.181

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urea nitrogen: change at week 1
0.9 Microgram per deciliter
Standard Deviation 4.57
0.6 Microgram per deciliter
Standard Deviation 3.04
0.1 Microgram per deciliter
Standard Deviation 3.12
1.0 Microgram per deciliter
Standard Deviation 3.19
1.0 Microgram per deciliter
Standard Deviation 3.05
0.2 Microgram per deciliter
Standard Deviation 2.19
0.4 Microgram per deciliter
Standard Deviation 3.38
-0.1 Microgram per deciliter
Standard Deviation 2.65
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urea nitrogen: change at week 2
0.8 Microgram per deciliter
Standard Deviation 3.89
0.0 Microgram per deciliter
Standard Deviation 2.71
0.6 Microgram per deciliter
Standard Deviation 3.54
0.9 Microgram per deciliter
Standard Deviation 3.18
0.5 Microgram per deciliter
Standard Deviation 3.63
0.6 Microgram per deciliter
Standard Deviation 4.19
0.8 Microgram per deciliter
Standard Deviation 2.99
0.4 Microgram per deciliter
Standard Deviation 3.28
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urea nitrogen: change at week 4
0.6 Microgram per deciliter
Standard Deviation 3.39
0.0 Microgram per deciliter
Standard Deviation 3.04
-0.0 Microgram per deciliter
Standard Deviation 2.67
1.4 Microgram per deciliter
Standard Deviation 3.06
0.5 Microgram per deciliter
Standard Deviation 3.84
-0.7 Microgram per deciliter
Standard Deviation 2.96
1.3 Microgram per deciliter
Standard Deviation 2.81
-0.2 Microgram per deciliter
Standard Deviation 3.61
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urea nitrogen: change at week 6
0.7 Microgram per deciliter
Standard Deviation 2.84
-0.2 Microgram per deciliter
Standard Deviation 3.11
-0.6 Microgram per deciliter
Standard Deviation 3.61
0.9 Microgram per deciliter
Standard Deviation 3.27
0.3 Microgram per deciliter
Standard Deviation 3.82
-0.8 Microgram per deciliter
Standard Deviation 3.24
0.2 Microgram per deciliter
Standard Deviation 3.52
-0.4 Microgram per deciliter
Standard Deviation 3.69
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urea nitrogen: change at follow-up visit
0.0 Microgram per deciliter
Standard Deviation 3.17
-0.3 Microgram per deciliter
Standard Deviation 3.13
0.4 Microgram per deciliter
Standard Deviation 2.60
1.2 Microgram per deciliter
Standard Deviation 4.22
0.2 Microgram per deciliter
Standard Deviation 2.87
0.8 Microgram per deciliter
Standard Deviation 3.78
0.5 Microgram per deciliter
Standard Deviation 3.42
0.1 Microgram per deciliter
Standard Deviation 3.78
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urate:change at week 1
0.16 Microgram per deciliter
Standard Deviation 0.807
0.01 Microgram per deciliter
Standard Deviation 0.606
0.16 Microgram per deciliter
Standard Deviation 0.678
-0.01 Microgram per deciliter
Standard Deviation 0.561
0.00 Microgram per deciliter
Standard Deviation 0.739
0.05 Microgram per deciliter
Standard Deviation 0.661
-0.02 Microgram per deciliter
Standard Deviation 0.704
-0.14 Microgram per deciliter
Standard Deviation 0.890
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urate: change at week 2
0.30 Microgram per deciliter
Standard Deviation 0.990
-0.11 Microgram per deciliter
Standard Deviation 0.655
0.12 Microgram per deciliter
Standard Deviation 0.617
-0.03 Microgram per deciliter
Standard Deviation 0.649
-0.15 Microgram per deciliter
Standard Deviation 0.842
0.27 Microgram per deciliter
Standard Deviation 1.025
-0.03 Microgram per deciliter
Standard Deviation 0.718
-0.37 Microgram per deciliter
Standard Deviation 1.059
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urate: change at week 4
0.21 Microgram per deciliter
Standard Deviation 0.497
0.14 Microgram per deciliter
Standard Deviation 0.731
0.06 Microgram per deciliter
Standard Deviation 0.756
-0.06 Microgram per deciliter
Standard Deviation 0.621
-0.14 Microgram per deciliter
Standard Deviation 0.856
0.22 Microgram per deciliter
Standard Deviation 0.806
-0.21 Microgram per deciliter
Standard Deviation 0.663
-0.16 Microgram per deciliter
Standard Deviation 0.713
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urate: change at week 6
0.13 Microgram per deciliter
Standard Deviation 0.728
0.07 Microgram per deciliter
Standard Deviation 0.984
-0.02 Microgram per deciliter
Standard Deviation 0.831
0.06 Microgram per deciliter
Standard Deviation 0.630
-0.02 Microgram per deciliter
Standard Deviation 0.649
0.06 Microgram per deciliter
Standard Deviation 0.534
-0.11 Microgram per deciliter
Standard Deviation 0.827
-0.21 Microgram per deciliter
Standard Deviation 1.084
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Urate: change at follow- up visit
-0.11 Microgram per deciliter
Standard Deviation 0.721
-0.33 Microgram per deciliter
Standard Deviation 0.753
0.05 Microgram per deciliter
Standard Deviation 0.763
-0.21 Microgram per deciliter
Standard Deviation 0.554
-0.02 Microgram per deciliter
Standard Deviation 0.810
0.02 Microgram per deciliter
Standard Deviation 0.590
-0.08 Microgram per deciliter
Standard Deviation 0.677
-0.20 Microgram per deciliter
Standard Deviation 0.989
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Calcium:change at week 1
0.01 Microgram per deciliter
Standard Deviation 0.419
0.01 Microgram per deciliter
Standard Deviation 0.259
-0.06 Microgram per deciliter
Standard Deviation 0.377
-0.02 Microgram per deciliter
Standard Deviation 0.248
0.07 Microgram per deciliter
Standard Deviation 0.386
-0.02 Microgram per deciliter
Standard Deviation 0.303
-0.01 Microgram per deciliter
Standard Deviation 0.295
0.09 Microgram per deciliter
Standard Deviation 0.318
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Calcium: change at week 2
-0.08 Microgram per deciliter
Standard Deviation 0.417
0.00 Microgram per deciliter
Standard Deviation 0.268
-0.10 Microgram per deciliter
Standard Deviation 0.362
0.05 Microgram per deciliter
Standard Deviation 0.296
0.07 Microgram per deciliter
Standard Deviation 0.423
0.03 Microgram per deciliter
Standard Deviation 0.389
-0.10 Microgram per deciliter
Standard Deviation 0.293
-0.01 Microgram per deciliter
Standard Deviation 0.244
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Calcium: change at week 4
-0.04 Microgram per deciliter
Standard Deviation 0.354
0.11 Microgram per deciliter
Standard Deviation 0.329
-0.07 Microgram per deciliter
Standard Deviation 0.345
0.05 Microgram per deciliter
Standard Deviation 0.272
0.00 Microgram per deciliter
Standard Deviation 0.376
-0.08 Microgram per deciliter
Standard Deviation 0.309
-0.03 Microgram per deciliter
Standard Deviation 0.257
0.10 Microgram per deciliter
Standard Deviation 0.341
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Calcium: change at week 6
-0.04 Microgram per deciliter
Standard Deviation 0.355
0.10 Microgram per deciliter
Standard Deviation 0.303
-0.21 Microgram per deciliter
Standard Deviation 0.393
0.03 Microgram per deciliter
Standard Deviation 0.315
0.00 Microgram per deciliter
Standard Deviation 0.397
-0.05 Microgram per deciliter
Standard Deviation 0.335
-0.05 Microgram per deciliter
Standard Deviation 0.464
-0.04 Microgram per deciliter
Standard Deviation 0.337
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Calcium: change at follow-up visit
0.00 Microgram per deciliter
Standard Deviation 0.317
-0.01 Microgram per deciliter
Standard Deviation 0.345
-0.08 Microgram per deciliter
Standard Deviation 0.409
0.00 Microgram per deciliter
Standard Deviation 0.323
0.10 Microgram per deciliter
Standard Deviation 0.441
-0.05 Microgram per deciliter
Standard Deviation 0.419
0.01 Microgram per deciliter
Standard Deviation 0.378
0.05 Microgram per deciliter
Standard Deviation 0.356
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Glucose:change at week 1
4.9 Microgram per deciliter
Standard Deviation 8.73
5.7 Microgram per deciliter
Standard Deviation 13.97
3.4 Microgram per deciliter
Standard Deviation 14.62
4.5 Microgram per deciliter
Standard Deviation 8.60
4.4 Microgram per deciliter
Standard Deviation 16.14
4.5 Microgram per deciliter
Standard Deviation 29.90
5.6 Microgram per deciliter
Standard Deviation 13.14
3.3 Microgram per deciliter
Standard Deviation 13.58
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Glucose: change at week 2
9.7 Microgram per deciliter
Standard Deviation 23.71
1.2 Microgram per deciliter
Standard Deviation 17.34
0.6 Microgram per deciliter
Standard Deviation 10.97
3.2 Microgram per deciliter
Standard Deviation 12.63
3.1 Microgram per deciliter
Standard Deviation 10.00
-1.9 Microgram per deciliter
Standard Deviation 13.51
7.9 Microgram per deciliter
Standard Deviation 16.67
2.7 Microgram per deciliter
Standard Deviation 18.07
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Glucose: change at week 4
7.3 Microgram per deciliter
Standard Deviation 15.60
0.5 Microgram per deciliter
Standard Deviation 12.50
-1.2 Microgram per deciliter
Standard Deviation 15.86
4.5 Microgram per deciliter
Standard Deviation 13.99
2.8 Microgram per deciliter
Standard Deviation 20.20
1.3 Microgram per deciliter
Standard Deviation 24.01
10.7 Microgram per deciliter
Standard Deviation 26.13
3.4 Microgram per deciliter
Standard Deviation 18.33
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Glucose: change at week 6
3.5 Microgram per deciliter
Standard Deviation 9.19
2.4 Microgram per deciliter
Standard Deviation 17.55
-1.7 Microgram per deciliter
Standard Deviation 10.62
2.1 Microgram per deciliter
Standard Deviation 13.80
-0.5 Microgram per deciliter
Standard Deviation 9.77
-3.4 Microgram per deciliter
Standard Deviation 16.37
4.3 Microgram per deciliter
Standard Deviation 12.23
1.5 Microgram per deciliter
Standard Deviation 12.62
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Glucose: change at follow -up visit
4.5 Microgram per deciliter
Standard Deviation 11.58
2.2 Microgram per deciliter
Standard Deviation 11.45
4.8 Microgram per deciliter
Standard Deviation 13.28
4.6 Microgram per deciliter
Standard Deviation 14.77
6.0 Microgram per deciliter
Standard Deviation 13.79
6.2 Microgram per deciliter
Standard Deviation 16.75
9.1 Microgram per deciliter
Standard Deviation 17.21
2.0 Microgram per deciliter
Standard Deviation 22.43

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Sodium: change at week 1
0.1 Milliequivalents per liter
Standard Deviation 2.34
-0.0 Milliequivalents per liter
Standard Deviation 1.77
-0.7 Milliequivalents per liter
Standard Deviation 2.04
-0.6 Milliequivalents per liter
Standard Deviation 2.17
-0.4 Milliequivalents per liter
Standard Deviation 3.50
0.4 Milliequivalents per liter
Standard Deviation 1.97
0.0 Milliequivalents per liter
Standard Deviation 2.08
-0.1 Milliequivalents per liter
Standard Deviation 3.39
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Sodium: change at week 2
-0.5 Milliequivalents per liter
Standard Deviation 2.23
-0.3 Milliequivalents per liter
Standard Deviation 1.89
-0.1 Milliequivalents per liter
Standard Deviation 2.39
-0.2 Milliequivalents per liter
Standard Deviation 2.18
-0.4 Milliequivalents per liter
Standard Deviation 3.61
-0.2 Milliequivalents per liter
Standard Deviation 2.61
-0.5 Milliequivalents per liter
Standard Deviation 2.20
-0.3 Milliequivalents per liter
Standard Deviation 3.45
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Sodium:change at week 4
-0.3 Milliequivalents per liter
Standard Deviation 2.70
0.6 Milliequivalents per liter
Standard Deviation 1.83
-0.2 Milliequivalents per liter
Standard Deviation 2.44
-0.7 Milliequivalents per liter
Standard Deviation 2.71
-0.4 Milliequivalents per liter
Standard Deviation 3.08
-0.4 Milliequivalents per liter
Standard Deviation 2.72
-0.1 Milliequivalents per liter
Standard Deviation 1.77
-0.3 Milliequivalents per liter
Standard Deviation 3.28
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Sodium:change at week 6
-0.8 Milliequivalents per liter
Standard Deviation 2.31
0.0 Milliequivalents per liter
Standard Deviation 2.39
-0.2 Milliequivalents per liter
Standard Deviation 2.23
-0.9 Milliequivalents per liter
Standard Deviation 2.40
-0.9 Milliequivalents per liter
Standard Deviation 3.55
0.9 Milliequivalents per liter
Standard Deviation 2.50
-0.1 Milliequivalents per liter
Standard Deviation 2.23
-0.5 Milliequivalents per liter
Standard Deviation 2.49
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Sodium: change at follow up
-0.4 Milliequivalents per liter
Standard Deviation 3.26
0.5 Milliequivalents per liter
Standard Deviation 2.50
-0.1 Milliequivalents per liter
Standard Deviation 2.45
-0.3 Milliequivalents per liter
Standard Deviation 2.41
-0.8 Milliequivalents per liter
Standard Deviation 3.59
0.7 Milliequivalents per liter
Standard Deviation 1.94
-0.1 Milliequivalents per liter
Standard Deviation 2.46
0.1 Milliequivalents per liter
Standard Deviation 3.32
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Potassium: change at week 1
-0.00 Milliequivalents per liter
Standard Deviation 0.363
0.08 Milliequivalents per liter
Standard Deviation 0.282
0.03 Milliequivalents per liter
Standard Deviation 0.372
0.02 Milliequivalents per liter
Standard Deviation 0.347
0.07 Milliequivalents per liter
Standard Deviation 0.343
0.01 Milliequivalents per liter
Standard Deviation 0.337
0.00 Milliequivalents per liter
Standard Deviation 0.429
0.20 Milliequivalents per liter
Standard Deviation 0.464
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Potassium:change at week 2
-0.14 Milliequivalents per liter
Standard Deviation 0.367
0.04 Milliequivalents per liter
Standard Deviation 0.298
-0.07 Milliequivalents per liter
Standard Deviation 0.338
0.04 Milliequivalents per liter
Standard Deviation 0.359
0.07 Milliequivalents per liter
Standard Deviation 0.346
0.00 Milliequivalents per liter
Standard Deviation 0.245
-0.16 Milliequivalents per liter
Standard Deviation 0.438
-0.02 Milliequivalents per liter
Standard Deviation 0.322
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Potassium: change at week 4
0.01 Milliequivalents per liter
Standard Deviation 0.389
-0.06 Milliequivalents per liter
Standard Deviation 0.285
-0.02 Milliequivalents per liter
Standard Deviation 0.350
-0.01 Milliequivalents per liter
Standard Deviation 0.327
0.05 Milliequivalents per liter
Standard Deviation 0.375
-0.09 Milliequivalents per liter
Standard Deviation 0.300
-0.03 Milliequivalents per liter
Standard Deviation 0.415
0.26 Milliequivalents per liter
Standard Deviation 0.350
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Potassium: change at week 6
-0.09 Milliequivalents per liter
Standard Deviation 0.373
0.03 Milliequivalents per liter
Standard Deviation 0.295
-0.06 Milliequivalents per liter
Standard Deviation 0.332
0.03 Milliequivalents per liter
Standard Deviation 0.407
-0.06 Milliequivalents per liter
Standard Deviation 0.262
-0.06 Milliequivalents per liter
Standard Deviation 0.309
-0.10 Milliequivalents per liter
Standard Deviation 0.355
0.09 Milliequivalents per liter
Standard Deviation 0.388
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Potassium: change at follow-up visit
-0.11 Milliequivalents per liter
Standard Deviation 0.379
0.10 Milliequivalents per liter
Standard Deviation 0.375
0.03 Milliequivalents per liter
Standard Deviation 0.394
0.04 Milliequivalents per liter
Standard Deviation 0.351
0.12 Milliequivalents per liter
Standard Deviation 0.358
0.05 Milliequivalents per liter
Standard Deviation 0.293
-0.09 Milliequivalents per liter
Standard Deviation 0.475
0.26 Milliequivalents per liter
Standard Deviation 0.460
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Chloride: change at week 1
0.1 Milliequivalents per liter
Standard Deviation 2.11
0.3 Milliequivalents per liter
Standard Deviation 1.86
0.3 Milliequivalents per liter
Standard Deviation 1.57
0.0 Milliequivalents per liter
Standard Deviation 2.54
0.0 Milliequivalents per liter
Standard Deviation 2.66
0.6 Milliequivalents per liter
Standard Deviation 2.11
0.5 Milliequivalents per liter
Standard Deviation 2.02
0.5 Milliequivalents per liter
Standard Deviation 2.83
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Chloride: change at week 2
-0.2 Milliequivalents per liter
Standard Deviation 2.52
-0.2 Milliequivalents per liter
Standard Deviation 2.08
0.7 Milliequivalents per liter
Standard Deviation 2.03
0.2 Milliequivalents per liter
Standard Deviation 2.50
-0.2 Milliequivalents per liter
Standard Deviation 2.87
0.4 Milliequivalents per liter
Standard Deviation 2.70
0.4 Milliequivalents per liter
Standard Deviation 2.15
0.2 Milliequivalents per liter
Standard Deviation 2.99
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Chloride: change at week 4
0.3 Milliequivalents per liter
Standard Deviation 2.05
0.6 Milliequivalents per liter
Standard Deviation 1.89
0.2 Milliequivalents per liter
Standard Deviation 2.68
-0.4 Milliequivalents per liter
Standard Deviation 2.23
-0.3 Milliequivalents per liter
Standard Deviation 2.16
0.3 Milliequivalents per liter
Standard Deviation 3.28
1.0 Milliequivalents per liter
Standard Deviation 2.21
-0.2 Milliequivalents per liter
Standard Deviation 2.57
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Chloride:change at week 6
-0.6 Milliequivalents per liter
Standard Deviation 1.98
0.1 Milliequivalents per liter
Standard Deviation 2.27
0.0 Milliequivalents per liter
Standard Deviation 2.34
-0.5 Milliequivalents per liter
Standard Deviation 2.44
-0.4 Milliequivalents per liter
Standard Deviation 3.05
0.5 Milliequivalents per liter
Standard Deviation 2.93
0.9 Milliequivalents per liter
Standard Deviation 2.73
0.0 Milliequivalents per liter
Standard Deviation 2.32
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Chloride: change at follow-up visit
0.6 Milliequivalents per liter
Standard Deviation 2.97
-0.3 Milliequivalents per liter
Standard Deviation 2.16
0.8 Milliequivalents per liter
Standard Deviation 2.64
0.1 Milliequivalents per liter
Standard Deviation 2.41
-0.4 Milliequivalents per liter
Standard Deviation 2.90
1.3 Milliequivalents per liter
Standard Deviation 2.11
0.3 Milliequivalents per liter
Standard Deviation 2.35
0.4 Milliequivalents per liter
Standard Deviation 3.16
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Bicarbonate: change at week 1
0.13 Milliequivalents per liter
Standard Deviation 2.548
-0.38 Milliequivalents per liter
Standard Deviation 1.759
-0.20 Milliequivalents per liter
Standard Deviation 1.965
-0.18 Milliequivalents per liter
Standard Deviation 1.768
0.28 Milliequivalents per liter
Standard Deviation 1.638
0.09 Milliequivalents per liter
Standard Deviation 2.209
-0.21 Milliequivalents per liter
Standard Deviation 2.388
-0.02 Milliequivalents per liter
Standard Deviation 1.651
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Bicarbonate: change at week 2
0.08 Milliequivalents per liter
Standard Deviation 2.229
-0.40 Milliequivalents per liter
Standard Deviation 2.151
-0.51 Milliequivalents per liter
Standard Deviation 1.956
0.10 Milliequivalents per liter
Standard Deviation 2.129
-0.13 Milliequivalents per liter
Standard Deviation 1.931
-0.15 Milliequivalents per liter
Standard Deviation 2.341
-0.60 Milliequivalents per liter
Standard Deviation 2.354
-0.07 Milliequivalents per liter
Standard Deviation 1.828
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Bicarbonate: change at week 4
0.21 Milliequivalents per liter
Standard Deviation 2.739
0.05 Milliequivalents per liter
Standard Deviation 2.128
-0.24 Milliequivalents per liter
Standard Deviation 2.484
0.34 Milliequivalents per liter
Standard Deviation 1.868
0.02 Milliequivalents per liter
Standard Deviation 2.011
0.14 Milliequivalents per liter
Standard Deviation 1.286
-0.00 Milliequivalents per liter
Standard Deviation 2.695
0.02 Milliequivalents per liter
Standard Deviation 1.704
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Bicarbonate: change at week 6
0.52 Milliequivalents per liter
Standard Deviation 2.560
-0.44 Milliequivalents per liter
Standard Deviation 2.598
0.66 Milliequivalents per liter
Standard Deviation 2.132
0.27 Milliequivalents per liter
Standard Deviation 2.204
0.12 Milliequivalents per liter
Standard Deviation 2.407
0.63 Milliequivalents per liter
Standard Deviation 2.096
-0.19 Milliequivalents per liter
Standard Deviation 2.038
-0.20 Milliequivalents per liter
Standard Deviation 2.217
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Bicarbonate: change at follow-up visit
-0.02 Milliequivalents per liter
Standard Deviation 2.916
0.66 Milliequivalents per liter
Standard Deviation 2.209
0.41 Milliequivalents per liter
Standard Deviation 2.056
0.75 Milliequivalents per liter
Standard Deviation 2.386
0.43 Milliequivalents per liter
Standard Deviation 2.162
0.08 Milliequivalents per liter
Standard Deviation 1.643
0.18 Milliequivalents per liter
Standard Deviation 2.300
1.09 Milliequivalents per liter
Standard Deviation 2.049

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=33 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at week 1
-0.01 Gram per deciliter
Standard Deviation 0.790
-0.22 Gram per deciliter
Standard Deviation 0.620
-0.36 Gram per deciliter
Standard Deviation 0.775
-0.12 Gram per deciliter
Standard Deviation 0.678
-0.26 Gram per deciliter
Standard Deviation 0.726
-0.19 Gram per deciliter
Standard Deviation 0.698
-0.21 Gram per deciliter
Standard Deviation 0.584
-0.27 Gram per deciliter
Standard Deviation 0.679
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at week 2
-0.16 Gram per deciliter
Standard Deviation 0.636
-0.09 Gram per deciliter
Standard Deviation 0.566
-0.64 Gram per deciliter
Standard Deviation 0.715
-0.24 Gram per deciliter
Standard Deviation 0.657
-0.22 Gram per deciliter
Standard Deviation 0.798
-0.16 Gram per deciliter
Standard Deviation 0.830
-0.25 Gram per deciliter
Standard Deviation 0.625
-0.32 Gram per deciliter
Standard Deviation 0.793
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at week 4
0.03 Gram per deciliter
Standard Deviation 0.725
-0.17 Gram per deciliter
Standard Deviation 0.630
-0.48 Gram per deciliter
Standard Deviation 0.659
-0.25 Gram per deciliter
Standard Deviation 0.628
-0.06 Gram per deciliter
Standard Deviation 0.821
-0.27 Gram per deciliter
Standard Deviation 0.789
-0.32 Gram per deciliter
Standard Deviation 0.701
-0.20 Gram per deciliter
Standard Deviation 0.658
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at week 6
-0.13 Gram per deciliter
Standard Deviation 0.832
-0.06 Gram per deciliter
Standard Deviation 0.614
-0.48 Gram per deciliter
Standard Deviation 0.767
-0.03 Gram per deciliter
Standard Deviation 0.617
-0.11 Gram per deciliter
Standard Deviation 0.775
-0.22 Gram per deciliter
Standard Deviation 0.724
-0.21 Gram per deciliter
Standard Deviation 0.833
-0.28 Gram per deciliter
Standard Deviation 0.683
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change at follow-up visit
0.05 Gram per deciliter
Standard Deviation 0.613
-0.04 Gram per deciliter
Standard Deviation 0.717
-0.49 Gram per deciliter
Standard Deviation 0.777
-0.09 Gram per deciliter
Standard Deviation 0.784
0.00 Gram per deciliter
Standard Deviation 0.773
-0.27 Gram per deciliter
Standard Deviation 0.756
-0.12 Gram per deciliter
Standard Deviation 0.826
-0.18 Gram per deciliter
Standard Deviation 0.740

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=33 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Hematocrit: change at week 4
0.0 Percentage of cells
Standard Deviation 2.45
-0.8 Percentage of cells
Standard Deviation 1.96
-1.8 Percentage of cells
Standard Deviation 2.06
-0.8 Percentage of cells
Standard Deviation 2.34
0.0 Percentage of cells
Standard Deviation 2.73
-1.0 Percentage of cells
Standard Deviation 2.34
-0.9 Percentage of cells
Standard Deviation 2.29
-0.5 Percentage of cells
Standard Deviation 2.56
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Hematocrit: change at week 6
-0.6 Percentage of cells
Standard Deviation 2.47
-0.9 Percentage of cells
Standard Deviation 1.93
-1.6 Percentage of cells
Standard Deviation 2.64
-0.7 Percentage of cells
Standard Deviation 2.23
-0.6 Percentage of cells
Standard Deviation 2.51
-1.1 Percentage of cells
Standard Deviation 1.98
-1.1 Percentage of cells
Standard Deviation 2.84
-0.8 Percentage of cells
Standard Deviation 2.60
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Hematocrit: change at week 1
0.2 Percentage of cells
Standard Deviation 2.51
-0.8 Percentage of cells
Standard Deviation 2.11
-1.3 Percentage of cells
Standard Deviation 2.61
-0.4 Percentage of cells
Standard Deviation 2.27
-0.8 Percentage of cells
Standard Deviation 2.41
-0.5 Percentage of cells
Standard Deviation 1.97
-0.9 Percentage of cells
Standard Deviation 2.04
-0.9 Percentage of cells
Standard Deviation 2.30
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Hematocrit: change at week 2
-0.5 Percentage of cells
Standard Deviation 2.19
-0.8 Percentage of cells
Standard Deviation 2.12
-1.8 Percentage of cells
Standard Deviation 2.42
-0.9 Percentage of cells
Standard Deviation 2.32
-0.7 Percentage of cells
Standard Deviation 2.58
-0.9 Percentage of cells
Standard Deviation 2.55
-0.7 Percentage of cells
Standard Deviation 2.24
-1.0 Percentage of cells
Standard Deviation 2.61
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Hematocrit: change at follow-up (FU) visit
0.3 Percentage of cells
Standard Deviation 2.49
-0.7 Percentage of cells
Standard Deviation 2.24
-1.4 Percentage of cells
Standard Deviation 3.05
-0.7 Percentage of cells
Standard Deviation 2.39
-0.2 Percentage of cells
Standard Deviation 2.50
-0.6 Percentage of cells
Standard Deviation 2.20
-0.6 Percentage of cells
Standard Deviation 2.73
-0.3 Percentage of cells
Standard Deviation 2.78
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes/Erythrocytes change at week 1
0.03 Percentage of cells
Standard Deviation 0.317
0.14 Percentage of cells
Standard Deviation 0.378
0.02 Percentage of cells
Standard Deviation 0.483
0.06 Percentage of cells
Standard Deviation 0.364
0.11 Percentage of cells
Standard Deviation 0.318
0.01 Percentage of cells
Standard Deviation 0.320
0.04 Percentage of cells
Standard Deviation 0.355
0.01 Percentage of cells
Standard Deviation 0.329
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes/Erythrocytes: change at week 2
-0.03 Percentage of cells
Standard Deviation 0.382
0.17 Percentage of cells
Standard Deviation 0.325
0.09 Percentage of cells
Standard Deviation 0.413
-0.02 Percentage of cells
Standard Deviation 0.473
0.19 Percentage of cells
Standard Deviation 0.443
-0.10 Percentage of cells
Standard Deviation 0.318
0.06 Percentage of cells
Standard Deviation 0.315
-0.01 Percentage of cells
Standard Deviation 0.389
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes/Erythrocytes: change at week 4
0.16 Percentage of cells
Standard Deviation 0.596
-0.08 Percentage of cells
Standard Deviation 0.359
0.01 Percentage of cells
Standard Deviation 0.460
0.19 Percentage of cells
Standard Deviation 0.429
0.10 Percentage of cells
Standard Deviation 0.409
0.03 Percentage of cells
Standard Deviation 0.290
0.04 Percentage of cells
Standard Deviation 0.446
0.05 Percentage of cells
Standard Deviation 0.374
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes/Erythrocytes: change at week 6
-0.06 Percentage of cells
Standard Deviation 0.382
0.02 Percentage of cells
Standard Deviation 0.361
0.02 Percentage of cells
Standard Deviation 0.473
0.01 Percentage of cells
Standard Deviation 0.486
0.15 Percentage of cells
Standard Deviation 0.399
-0.15 Percentage of cells
Standard Deviation 0.310
-0.01 Percentage of cells
Standard Deviation 0.355
0.01 Percentage of cells
Standard Deviation 0.463
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes/Erythrocytes:change at FU visit
-0.11 Percentage of cells
Standard Deviation 0.396
-0.02 Percentage of cells
Standard Deviation 0.384
0.10 Percentage of cells
Standard Deviation 0.435
-0.10 Percentage of cells
Standard Deviation 0.398
-0.03 Percentage of cells
Standard Deviation 0.298
-0.09 Percentage of cells
Standard Deviation 0.331
-0.19 Percentage of cells
Standard Deviation 0.395
0.11 Percentage of cells
Standard Deviation 0.448
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes/Leukocytes: change at week 1
-0.43 Percentage of cells
Standard Deviation 6.772
0.68 Percentage of cells
Standard Deviation 5.814
2.33 Percentage of cells
Standard Deviation 5.616
0.06 Percentage of cells
Standard Deviation 4.765
1.31 Percentage of cells
Standard Deviation 6.259
0.59 Percentage of cells
Standard Deviation 5.179
0.49 Percentage of cells
Standard Deviation 5.509
1.79 Percentage of cells
Standard Deviation 6.269
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes/Leukocytes: change at week 2
0.20 Percentage of cells
Standard Deviation 6.175
0.84 Percentage of cells
Standard Deviation 7.544
1.68 Percentage of cells
Standard Deviation 5.208
1.50 Percentage of cells
Standard Deviation 5.639
0.23 Percentage of cells
Standard Deviation 6.175
0.50 Percentage of cells
Standard Deviation 5.405
0.72 Percentage of cells
Standard Deviation 6.638
0.86 Percentage of cells
Standard Deviation 7.264
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes/Leukocytes: change at week 4
1.58 Percentage of cells
Standard Deviation 7.591
0.51 Percentage of cells
Standard Deviation 7.297
1.43 Percentage of cells
Standard Deviation 5.298
0.43 Percentage of cells
Standard Deviation 7.586
2.41 Percentage of cells
Standard Deviation 6.577
-1.38 Percentage of cells
Standard Deviation 5.415
1.07 Percentage of cells
Standard Deviation 5.739
0.56 Percentage of cells
Standard Deviation 7.264
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes/Leukocytes: change at week 6
-0.92 Percentage of cells
Standard Deviation 6.701
-0.06 Percentage of cells
Standard Deviation 5.461
0.82 Percentage of cells
Standard Deviation 6.685
1.28 Percentage of cells
Standard Deviation 5.881
1.65 Percentage of cells
Standard Deviation 5.818
0.50 Percentage of cells
Standard Deviation 4.452
-0.04 Percentage of cells
Standard Deviation 5.300
1.52 Percentage of cells
Standard Deviation 7.266
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes/Leukocytes: change at follow-up visit
1.53 Percentage of cells
Standard Deviation 6.219
1.25 Percentage of cells
Standard Deviation 4.974
1.61 Percentage of cells
Standard Deviation 6.597
-0.85 Percentage of cells
Standard Deviation 6.367
1.34 Percentage of cells
Standard Deviation 6.165
0.22 Percentage of cells
Standard Deviation 6.315
0.07 Percentage of cells
Standard Deviation 5.103
2.48 Percentage of cells
Standard Deviation 6.914
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils/Leukocytes: change at week 1
0.57 Percentage of cells
Standard Deviation 7.515
-0.95 Percentage of cells
Standard Deviation 6.957
-2.93 Percentage of cells
Standard Deviation 6.191
0.30 Percentage of cells
Standard Deviation 5.755
-0.96 Percentage of cells
Standard Deviation 7.843
-0.17 Percentage of cells
Standard Deviation 5.769
-1.87 Percentage of cells
Standard Deviation 6.873
-1.44 Percentage of cells
Standard Deviation 6.580
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils/Leukocytes: change at week 2
-0.12 Percentage of cells
Standard Deviation 7.827
-0.34 Percentage of cells
Standard Deviation 8.219
-1.70 Percentage of cells
Standard Deviation 6.037
-1.50 Percentage of cells
Standard Deviation 6.578
-0.24 Percentage of cells
Standard Deviation 6.146
-0.49 Percentage of cells
Standard Deviation 6.665
-1.04 Percentage of cells
Standard Deviation 7.376
-0.56 Percentage of cells
Standard Deviation 8.017
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils/Leukocytes: change at week 4
-1.42 Percentage of cells
Standard Deviation 8.812
-0.30 Percentage of cells
Standard Deviation 7.754
-1.52 Percentage of cells
Standard Deviation 6.661
0.06 Percentage of cells
Standard Deviation 8.536
-2.25 Percentage of cells
Standard Deviation 7.468
1.65 Percentage of cells
Standard Deviation 6.622
-1.42 Percentage of cells
Standard Deviation 6.498
-0.45 Percentage of cells
Standard Deviation 7.362
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils/Leukocytes: change at week 6
0.95 Percentage of cells
Standard Deviation 8.648
-0.58 Percentage of cells
Standard Deviation 7.009
-0.64 Percentage of cells
Standard Deviation 6.833
-1.14 Percentage of cells
Standard Deviation 6.872
-1.15 Percentage of cells
Standard Deviation 6.969
-0.56 Percentage of cells
Standard Deviation 5.699
0.13 Percentage of cells
Standard Deviation 6.029
-1.01 Percentage of cells
Standard Deviation 8.445
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils/Leukocytes: change at follow-up visit
-1.71 Percentage of cells
Standard Deviation 7.046
-0.65 Percentage of cells
Standard Deviation 6.057
-1.86 Percentage of cells
Standard Deviation 6.892
1.32 Percentage of cells
Standard Deviation 7.355
-1.32 Percentage of cells
Standard Deviation 6.559
-0.41 Percentage of cells
Standard Deviation 6.961
-0.71 Percentage of cells
Standard Deviation 6.590
-2.04 Percentage of cells
Standard Deviation 7.700
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils/Leukocytes: change at week 1
-0.06 Percentage of cells
Standard Deviation 0.431
-0.02 Percentage of cells
Standard Deviation 0.690
-0.06 Percentage of cells
Standard Deviation 0.524
0.08 Percentage of cells
Standard Deviation 0.319
0.03 Percentage of cells
Standard Deviation 0.515
-0.03 Percentage of cells
Standard Deviation 0.291
-0.01 Percentage of cells
Standard Deviation 0.411
-0.01 Percentage of cells
Standard Deviation 0.570
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils/Leukocytes: change at week 2
-0.02 Percentage of cells
Standard Deviation 0.304
0.01 Percentage of cells
Standard Deviation 0.493
-0.09 Percentage of cells
Standard Deviation 0.342
0.02 Percentage of cells
Standard Deviation 0.323
-0.03 Percentage of cells
Standard Deviation 0.532
0.03 Percentage of cells
Standard Deviation 0.355
-0.06 Percentage of cells
Standard Deviation 0.624
-0.24 Percentage of cells
Standard Deviation 0.709
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils/Leukocytes: change at week 4
-0.07 Percentage of cells
Standard Deviation 0.485
0.06 Percentage of cells
Standard Deviation 0.651
-0.03 Percentage of cells
Standard Deviation 0.420
0.01 Percentage of cells
Standard Deviation 0.402
-0.08 Percentage of cells
Standard Deviation 0.712
-0.05 Percentage of cells
Standard Deviation 0.362
-0.01 Percentage of cells
Standard Deviation 0.465
-0.10 Percentage of cells
Standard Deviation 0.464
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils/Leukocytes: change at week 6
-0.07 Percentage of cells
Standard Deviation 0.272
0.11 Percentage of cells
Standard Deviation 0.809
-0.12 Percentage of cells
Standard Deviation 0.480
0.08 Percentage of cells
Standard Deviation 0.458
-0.16 Percentage of cells
Standard Deviation 0.557
-0.05 Percentage of cells
Standard Deviation 0.296
-0.12 Percentage of cells
Standard Deviation 0.576
-0.17 Percentage of cells
Standard Deviation 0.750
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils/Leukocytes: change at follow-up visit
-0.04 Percentage of cells
Standard Deviation 0.360
-0.15 Percentage of cells
Standard Deviation 0.476
-0.13 Percentage of cells
Standard Deviation 0.443
0.02 Percentage of cells
Standard Deviation 0.512
-0.25 Percentage of cells
Standard Deviation 0.541
-0.05 Percentage of cells
Standard Deviation 0.449
0.01 Percentage of cells
Standard Deviation 0.472
-0.25 Percentage of cells
Standard Deviation 0.572
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils/Leukocytes: change at week 1
-0.09 Percentage of cells
Standard Deviation 1.390
0.17 Percentage of cells
Standard Deviation 1.840
0.17 Percentage of cells
Standard Deviation 0.934
-0.37 Percentage of cells
Standard Deviation 1.549
-0.31 Percentage of cells
Standard Deviation 1.607
-0.19 Percentage of cells
Standard Deviation 1.410
0.89 Percentage of cells
Standard Deviation 1.850
-0.23 Percentage of cells
Standard Deviation 1.339
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils/Leukocytes: change at week 2
-0.11 Percentage of cells
Standard Deviation 1.801
-0.20 Percentage of cells
Standard Deviation 1.298
-0.16 Percentage of cells
Standard Deviation 1.284
0.11 Percentage of cells
Standard Deviation 1.460
-0.27 Percentage of cells
Standard Deviation 1.131
-0.14 Percentage of cells
Standard Deviation 1.199
0.16 Percentage of cells
Standard Deviation 1.304
-0.05 Percentage of cells
Standard Deviation 1.531
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils/Leukocytes: change at week 4
0.42 Percentage of cells
Standard Deviation 1.982
-0.12 Percentage of cells
Standard Deviation 1.725
0.15 Percentage of cells
Standard Deviation 1.884
-0.37 Percentage of cells
Standard Deviation 1.729
-0.35 Percentage of cells
Standard Deviation 1.431
-0.34 Percentage of cells
Standard Deviation 1.258
0.40 Percentage of cells
Standard Deviation 1.468
-0.37 Percentage of cells
Standard Deviation 1.747
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils/Leukocytes: change at week 6
-0.03 Percentage of cells
Standard Deviation 1.522
0.22 Percentage of cells
Standard Deviation 1.570
-0.04 Percentage of cells
Standard Deviation 1.213
0.02 Percentage of cells
Standard Deviation 2.126
-0.15 Percentage of cells
Standard Deviation 1.714
-0.01 Percentage of cells
Standard Deviation 1.767
0.05 Percentage of cells
Standard Deviation 1.229
-0.19 Percentage of cells
Standard Deviation 1.840
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils/Leukocytes: change at follow-up visit
0.16 Percentage of cells
Standard Deviation 1.754
-0.24 Percentage of cells
Standard Deviation 1.860
-0.09 Percentage of cells
Standard Deviation 1.155
-0.41 Percentage of cells
Standard Deviation 2.188
0.12 Percentage of cells
Standard Deviation 1.954
-0.05 Percentage of cells
Standard Deviation 2.805
0.50 Percentage of cells
Standard Deviation 1.986
-0.13 Percentage of cells
Standard Deviation 2.021
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes/Leukocytes: change at week 1
0.02 Percentage of cells
Standard Deviation 1.913
0.12 Percentage of cells
Standard Deviation 1.391
0.50 Percentage of cells
Standard Deviation 1.428
-0.06 Percentage of cells
Standard Deviation 1.409
-0.01 Percentage of cells
Standard Deviation 1.593
-0.19 Percentage of cells
Standard Deviation 1.043
0.51 Percentage of cells
Standard Deviation 1.275
-0.11 Percentage of cells
Standard Deviation 1.251
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes/Leukocytes: change at week 2
0.04 Percentage of cells
Standard Deviation 2.055
-0.31 Percentage of cells
Standard Deviation 1.502
0.30 Percentage of cells
Standard Deviation 1.522
-0.13 Percentage of cells
Standard Deviation 1.267
0.38 Percentage of cells
Standard Deviation 1.362
0.11 Percentage of cells
Standard Deviation 1.318
0.22 Percentage of cells
Standard Deviation 1.414
-0.01 Percentage of cells
Standard Deviation 1.755
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes/Leukocytes : change at week 4
-0.51 Percentage of cells
Standard Deviation 2.509
-0.17 Percentage of cells
Standard Deviation 1.966
-0.02 Percentage of cells
Standard Deviation 2.072
-0.10 Percentage of cells
Standard Deviation 1.582
0.22 Percentage of cells
Standard Deviation 1.323
0.14 Percentage of cells
Standard Deviation 1.323
-0.03 Percentage of cells
Standard Deviation 1.039
0.33 Percentage of cells
Standard Deviation 1.695
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes/Leukocytes : change at week 6
0.06 Percentage of cells
Standard Deviation 2.488
0.33 Percentage of cells
Standard Deviation 2.257
-0.00 Percentage of cells
Standard Deviation 1.813
-0.24 Percentage of cells
Standard Deviation 1.217
-0.12 Percentage of cells
Standard Deviation 1.030
0.13 Percentage of cells
Standard Deviation 0.807
-0.02 Percentage of cells
Standard Deviation 1.324
-0.16 Percentage of cells
Standard Deviation 1.516
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes/Leukocytes : change at follow-up visit
0.06 Percentage of cells
Standard Deviation 2.105
-0.22 Percentage of cells
Standard Deviation 1.304
0.50 Percentage of cells
Standard Deviation 1.463
-0.07 Percentage of cells
Standard Deviation 1.226
0.13 Percentage of cells
Standard Deviation 1.205
0.26 Percentage of cells
Standard Deviation 1.543
0.15 Percentage of cells
Standard Deviation 1.599
-0.04 Percentage of cells
Standard Deviation 1.047

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=33 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes: change at week 1
0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.01
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes: change at week 2
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Erythrocytes: change at week 1
0.03 10^12*cells per liter
Standard Deviation 0.261
-0.07 10^12*cells per liter
Standard Deviation 0.232
-0.12 10^12*cells per liter
Standard Deviation 0.264
-0.04 10^12*cells per liter
Standard Deviation 0.252
-0.08 10^12*cells per liter
Standard Deviation 0.254
-0.08 10^12*cells per liter
Standard Deviation 0.298
-0.08 10^12*cells per liter
Standard Deviation 0.192
-0.09 10^12*cells per liter
Standard Deviation 0.240
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Erythrocytes: change at week 2
-0.05 10^12*cells per liter
Standard Deviation 0.234
-0.03 10^12*cells per liter
Standard Deviation 0.212
-0.18 10^12*cells per liter
Standard Deviation 0.251
-0.10 10^12*cells per liter
Standard Deviation 0.208
-0.07 10^12*cells per liter
Standard Deviation 0.242
-0.10 10^12*cells per liter
Standard Deviation 0.366
-0.06 10^12*cells per liter
Standard Deviation 0.229
-0.11 10^12*cells per liter
Standard Deviation 0.232
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Erythrocytes: change at week 4
-0.01 10^12*cells per liter
Standard Deviation 0.216
-0.05 10^12*cells per liter
Standard Deviation 0.221
-0.16 10^12*cells per liter
Standard Deviation 0.251
-0.10 10^12*cells per liter
Standard Deviation 0.233
0.01 10^12*cells per liter
Standard Deviation 0.275
-0.12 10^12*cells per liter
Standard Deviation 0.271
-0.08 10^12*cells per liter
Standard Deviation 0.248
-0.06 10^12*cells per liter
Standard Deviation 0.219
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Erythrocytes: change at week 6
-0.04 10^12*cells per liter
Standard Deviation 0.247
-0.01 10^12*cells per liter
Standard Deviation 0.180
-0.17 10^12*cells per liter
Standard Deviation 0.265
-0.04 10^12*cells per liter
Standard Deviation 0.238
-0.02 10^12*cells per liter
Standard Deviation 0.262
-0.10 10^12*cells per liter
Standard Deviation 0.256
-0.07 10^12*cells per liter
Standard Deviation 0.303
-0.08 10^12*cells per liter
Standard Deviation 0.239
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Erythrocytes: change at follow-up visit
0.03 10^12*cells per liter
Standard Deviation 0.220
0.02 10^12*cells per liter
Standard Deviation 0.244
-0.15 10^12*cells per liter
Standard Deviation 0.266
-0.03 10^12*cells per liter
Standard Deviation 0.254
0.04 10^12*cells per liter
Standard Deviation 0.300
-0.08 10^12*cells per liter
Standard Deviation 0.280
-0.03 10^12*cells per liter
Standard Deviation 0.308
-0.05 10^12*cells per liter
Standard Deviation 0.262
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes: change at week 4
0.0 10^12*cells per liter
Standard Deviation 0.03
-0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.01
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes: change at week 6
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.01
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Reticulocytes: change at follow-up visit
-0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.01
-0.0 10^12*cells per liter
Standard Deviation 0.02
-0.0 10^12*cells per liter
Standard Deviation 0.02
0.0 10^12*cells per liter
Standard Deviation 0.02

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=34 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=33 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=33 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=35 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=34 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Platelets: change at week 1
0.9 10^9 *cells per liter
Standard Deviation 60.03
6.8 10^9 *cells per liter
Standard Deviation 34.08
-3.3 10^9 *cells per liter
Standard Deviation 32.39
1.0 10^9 *cells per liter
Standard Deviation 25.76
8.5 10^9 *cells per liter
Standard Deviation 41.61
6.6 10^9 *cells per liter
Standard Deviation 33.40
-2.1 10^9 *cells per liter
Standard Deviation 31.94
12.6 10^9 *cells per liter
Standard Deviation 44.08
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Platelets: change at week 2
-4.9 10^9 *cells per liter
Standard Deviation 58.16
7.1 10^9 *cells per liter
Standard Deviation 43.34
-8.1 10^9 *cells per liter
Standard Deviation 41.92
-0.1 10^9 *cells per liter
Standard Deviation 32.45
5.0 10^9 *cells per liter
Standard Deviation 31.39
-4.9 10^9 *cells per liter
Standard Deviation 31.84
7.5 10^9 *cells per liter
Standard Deviation 37.94
14.8 10^9 *cells per liter
Standard Deviation 50.99
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Platelets: change at week 4
10.5 10^9 *cells per liter
Standard Deviation 36.42
10.1 10^9 *cells per liter
Standard Deviation 37.55
-2.4 10^9 *cells per liter
Standard Deviation 37.68
-0.3 10^9 *cells per liter
Standard Deviation 36.27
-5.9 10^9 *cells per liter
Standard Deviation 37.47
4.4 10^9 *cells per liter
Standard Deviation 37.79
0.7 10^9 *cells per liter
Standard Deviation 36.51
11.0 10^9 *cells per liter
Standard Deviation 46.26
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Platelets: change at week 6
4.9 10^9 *cells per liter
Standard Deviation 35.17
-3.3 10^9 *cells per liter
Standard Deviation 32.76
-6.6 10^9 *cells per liter
Standard Deviation 41.66
-2.3 10^9 *cells per liter
Standard Deviation 32.70
-5.2 10^9 *cells per liter
Standard Deviation 38.53
0.2 10^9 *cells per liter
Standard Deviation 37.28
-1.8 10^9 *cells per liter
Standard Deviation 37.05
8.6 10^9 *cells per liter
Standard Deviation 47.85
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Platelets: change at follow-up visit
1.3 10^9 *cells per liter
Standard Deviation 30.48
16.3 10^9 *cells per liter
Standard Deviation 37.13
-8.5 10^9 *cells per liter
Standard Deviation 30.15
0.1 10^9 *cells per liter
Standard Deviation 32.36
10.2 10^9 *cells per liter
Standard Deviation 47.30
-5.2 10^9 *cells per liter
Standard Deviation 40.70
5.8 10^9 *cells per liter
Standard Deviation 48.55
2.5 10^9 *cells per liter
Standard Deviation 58.75
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Leukocytes: change at week 1
0.027 10^9 *cells per liter
Standard Deviation 1.8740
0.395 10^9 *cells per liter
Standard Deviation 1.0940
-0.051 10^9 *cells per liter
Standard Deviation 1.2403
0.407 10^9 *cells per liter
Standard Deviation 1.2225
0.259 10^9 *cells per liter
Standard Deviation 1.1290
0.068 10^9 *cells per liter
Standard Deviation 1.2929
0.238 10^9 *cells per liter
Standard Deviation 1.4993
-0.025 10^9 *cells per liter
Standard Deviation 2.3529
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Leukocytes: change at week 2
-0.206 10^9 *cells per liter
Standard Deviation 1.8886
0.459 10^9 *cells per liter
Standard Deviation 1.5567
-0.288 10^9 *cells per liter
Standard Deviation 1.6842
-0.094 10^9 *cells per liter
Standard Deviation 1.2877
-0.116 10^9 *cells per liter
Standard Deviation 1.0364
-0.007 10^9 *cells per liter
Standard Deviation 1.2637
0.422 10^9 *cells per liter
Standard Deviation 1.8986
-0.006 10^9 *cells per liter
Standard Deviation 2.3428
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Leukocytes: change at week 4
-0.203 10^9 *cells per liter
Standard Deviation 1.7390
0.729 10^9 *cells per liter
Standard Deviation 1.3199
0.189 10^9 *cells per liter
Standard Deviation 1.3534
0.085 10^9 *cells per liter
Standard Deviation 1.3541
-0.074 10^9 *cells per liter
Standard Deviation 1.0641
0.398 10^9 *cells per liter
Standard Deviation 1.5999
0.168 10^9 *cells per liter
Standard Deviation 1.0902
0.041 10^9 *cells per liter
Standard Deviation 2.1647
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Leukocytes: change at week 6
0.160 10^9 *cells per liter
Standard Deviation 1.7059
0.066 10^9 *cells per liter
Standard Deviation 1.0672
-0.505 10^9 *cells per liter
Standard Deviation 1.6474
0.237 10^9 *cells per liter
Standard Deviation 1.4501
-0.244 10^9 *cells per liter
Standard Deviation 1.2763
-0.269 10^9 *cells per liter
Standard Deviation 1.0761
-0.048 10^9 *cells per liter
Standard Deviation 1.3823
-0.347 10^9 *cells per liter
Standard Deviation 2.1442
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Leukocytes: change at follow-up visit
-0.066 10^9 *cells per liter
Standard Deviation 1.5744
0.479 10^9 *cells per liter
Standard Deviation 1.0939
-0.048 10^9 *cells per liter
Standard Deviation 2.0206
0.329 10^9 *cells per liter
Standard Deviation 1.3938
0.123 10^9 *cells per liter
Standard Deviation 0.8496
-0.117 10^9 *cells per liter
Standard Deviation 1.4856
0.210 10^9 *cells per liter
Standard Deviation 1.7456
-0.404 10^9 *cells per liter
Standard Deviation 2.4817
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes: change at week 1
-0.008 10^9 *cells per liter
Standard Deviation 0.5539
0.124 10^9 *cells per liter
Standard Deviation 0.3659
0.107 10^9 *cells per liter
Standard Deviation 0.3130
0.081 10^9 *cells per liter
Standard Deviation 0.3839
0.186 10^9 *cells per liter
Standard Deviation 0.3840
0.051 10^9 *cells per liter
Standard Deviation 0.3557
0.089 10^9 *cells per liter
Standard Deviation 0.4320
0.223 10^9 *cells per liter
Standard Deviation 0.3849
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes: change at week 2
-0.061 10^9 *cells per liter
Standard Deviation 0.5558
0.145 10^9 *cells per liter
Standard Deviation 0.3735
0.010 10^9 *cells per liter
Standard Deviation 0.4115
0.044 10^9 *cells per liter
Standard Deviation 0.4225
0.012 10^9 *cells per liter
Standard Deviation 0.4251
-0.003 10^9 *cells per liter
Standard Deviation 0.3165
0.070 10^9 *cells per liter
Standard Deviation 0.4603
0.169 10^9 *cells per liter
Standard Deviation 0.5319
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes: change at week 4
0.107 10^9 *cells per liter
Standard Deviation 0.4302
0.229 10^9 *cells per liter
Standard Deviation 0.3998
0.135 10^9 *cells per liter
Standard Deviation 0.4400
0.012 10^9 *cells per liter
Standard Deviation 0.4596
0.139 10^9 *cells per liter
Standard Deviation 0.3977
0.039 10^9 *cells per liter
Standard Deviation 0.4169
0.127 10^9 *cells per liter
Standard Deviation 0.2630
0.176 10^9 *cells per liter
Standard Deviation 0.6274
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes: change at week 6
0.033 10^9 *cells per liter
Standard Deviation 0.3375
0.016 10^9 *cells per liter
Standard Deviation 0.3437
-0.079 10^9 *cells per liter
Standard Deviation 0.4826
0.104 10^9 *cells per liter
Standard Deviation 0.4337
0.068 10^9 *cells per liter
Standard Deviation 0.3168
-0.033 10^9 *cells per liter
Standard Deviation 0.3092
0.027 10^9 *cells per liter
Standard Deviation 0.2455
0.079 10^9 *cells per liter
Standard Deviation 0.3846
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Lymphocytes: change at follow-up visit
0.134 10^9 *cells per liter
Standard Deviation 0.3256
0.194 10^9 *cells per liter
Standard Deviation 0.3533
0.065 10^9 *cells per liter
Standard Deviation 0.6042
-0.022 10^9 *cells per liter
Standard Deviation 0.4419
0.130 10^9 *cells per liter
Standard Deviation 0.4277
-0.035 10^9 *cells per liter
Standard Deviation 0.4054
0.050 10^9 *cells per liter
Standard Deviation 0.4699
0.195 10^9 *cells per liter
Standard Deviation 0.4663
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils: change at week 1
0.027 10^9 *cells per liter
Standard Deviation 1.6137
0.205 10^9 *cells per liter
Standard Deviation 0.9185
-0.177 10^9 *cells per liter
Standard Deviation 1.0805
0.319 10^9 *cells per liter
Standard Deviation 1.0276
0.069 10^9 *cells per liter
Standard Deviation 1.0706
0.017 10^9 *cells per liter
Standard Deviation 1.1291
0.030 10^9 *cells per liter
Standard Deviation 1.3015
-0.251 10^9 *cells per liter
Standard Deviation 2.2421
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils: change at week 2
-0.119 10^9 *cells per liter
Standard Deviation 1.5672
0.293 10^9 *cells per liter
Standard Deviation 1.5459
-0.261 10^9 *cells per liter
Standard Deviation 1.3969
-0.136 10^9 *cells per liter
Standard Deviation 1.0669
-0.109 10^9 *cells per liter
Standard Deviation 0.9653
-0.015 10^9 *cells per liter
Standard Deviation 1.1305
0.288 10^9 *cells per liter
Standard Deviation 1.7822
-0.190 10^9 *cells per liter
Standard Deviation 2.0749
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils: change at week 4
-0.304 10^9 *cells per liter
Standard Deviation 1.6117
0.441 10^9 *cells per liter
Standard Deviation 1.2814
0.036 10^9 *cells per liter
Standard Deviation 1.1595
0.096 10^9 *cells per liter
Standard Deviation 1.3199
-0.190 10^9 *cells per liter
Standard Deviation 1.0404
0.338 10^9 *cells per liter
Standard Deviation 1.3577
-0.005 10^9 *cells per liter
Standard Deviation 0.9958
-0.158 10^9 *cells per liter
Standard Deviation 2.0005
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils: change at week 6
0.112 10^9 *cells per liter
Standard Deviation 1.6282
-0.001 10^9 *cells per liter
Standard Deviation 0.8996
-0.362 10^9 *cells per liter
Standard Deviation 1.3154
0.112 10^9 *cells per liter
Standard Deviation 1.2240
-0.250 10^9 *cells per liter
Standard Deviation 1.1720
-0.228 10^9 *cells per liter
Standard Deviation 0.9681
-0.064 10^9 *cells per liter
Standard Deviation 1.2422
-0.376 10^9 *cells per liter
Standard Deviation 2.1125
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Neutrophils: change at follow-up visit
-0.229 10^9 *cells per liter
Standard Deviation 1.3379
0.261 10^9 *cells per liter
Standard Deviation 0.8874
-0.114 10^9 *cells per liter
Standard Deviation 1.4545
0.343 10^9 *cells per liter
Standard Deviation 1.3049
-0.020 10^9 *cells per liter
Standard Deviation 0.7731
-0.093 10^9 *cells per liter
Standard Deviation 1.2340
0.088 10^9 *cells per liter
Standard Deviation 1.4614
-0.562 10^9 *cells per liter
Standard Deviation 2.3227
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils: change at week 1
-0.006 10^9 *cells per liter
Standard Deviation 0.0319
0.004 10^9 *cells per liter
Standard Deviation 0.0445
-0.007 10^9 *cells per liter
Standard Deviation 0.0349
0.010 10^9 *cells per liter
Standard Deviation 0.0258
0.003 10^9 *cells per liter
Standard Deviation 0.0361
0.001 10^9 *cells per liter
Standard Deviation 0.0191
0.002 10^9 *cells per liter
Standard Deviation 0.0299
0.002 10^9 *cells per liter
Standard Deviation 0.0343
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils: change at week 2
-0.002 10^9 *cells per liter
Standard Deviation 0.0179
0.004 10^9 *cells per liter
Standard Deviation 0.0261
-0.009 10^9 *cells per liter
Standard Deviation 0.0276
0.001 10^9 *cells per liter
Standard Deviation 0.0197
-0.005 10^9 *cells per liter
Standard Deviation 0.0394
0.003 10^9 *cells per liter
Standard Deviation 0.0244
-0.003 10^9 *cells per liter
Standard Deviation 0.0433
-0.012 10^9 *cells per liter
Standard Deviation 0.0428
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils: change at week 4
-0.006 10^9 *cells per liter
Standard Deviation 0.0328
0.011 10^9 *cells per liter
Standard Deviation 0.0404
-0.002 10^9 *cells per liter
Standard Deviation 0.0300
0.001 10^9 *cells per liter
Standard Deviation 0.0256
-0.007 10^9 *cells per liter
Standard Deviation 0.0495
-0.001 10^9 *cells per liter
Standard Deviation 0.0255
-0.001 10^9 *cells per liter
Standard Deviation 0.0337
-0.004 10^9 *cells per liter
Standard Deviation 0.0323
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils: change at week 6
-0.005 10^9 *cells per liter
Standard Deviation 0.0186
0.009 10^9 *cells per liter
Standard Deviation 0.0489
-0.012 10^9 *cells per liter
Standard Deviation 0.0313
0.008 10^9 *cells per liter
Standard Deviation 0.0344
-0.015 10^9 *cells per liter
Standard Deviation 0.0415
-0.004 10^9 *cells per liter
Standard Deviation 0.0188
-0.009 10^9 *cells per liter
Standard Deviation 0.0373
-0.015 10^9 *cells per liter
Standard Deviation 0.0383
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Basophils: change at follow-up visit
-0.004 10^9 *cells per liter
Standard Deviation 0.0265
-0.003 10^9 *cells per liter
Standard Deviation 0.0259
-0.007 10^9 *cells per liter
Standard Deviation 0.0321
0.007 10^9 *cells per liter
Standard Deviation 0.0407
-0.015 10^9 *cells per liter
Standard Deviation 0.0426
-0.005 10^9 *cells per liter
Standard Deviation 0.0269
0.001 10^9 *cells per liter
Standard Deviation 0.0295
-0.019 10^9 *cells per liter
Standard Deviation 0.0361
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils: change at week 1
0.007 10^9 *cells per liter
Standard Deviation 0.0964
0.036 10^9 *cells per liter
Standard Deviation 0.0963
-0.004 10^9 *cells per liter
Standard Deviation 0.1092
-0.011 10^9 *cells per liter
Standard Deviation 0.0930
-0.014 10^9 *cells per liter
Standard Deviation 0.1216
-0.008 10^9 *cells per liter
Standard Deviation 0.1148
0.068 10^9 *cells per liter
Standard Deviation 0.0959
-0.006 10^9 *cells per liter
Standard Deviation 0.1165
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils: change at week 2
-0.019 10^9 *cells per liter
Standard Deviation 0.1087
-0.000 10^9 *cells per liter
Standard Deviation 0.0734
-0.023 10^9 *cells per liter
Standard Deviation 0.0809
0.009 10^9 *cells per liter
Standard Deviation 0.0980
-0.029 10^9 *cells per liter
Standard Deviation 0.0915
-0.006 10^9 *cells per liter
Standard Deviation 0.0621
0.022 10^9 *cells per liter
Standard Deviation 0.0762
0.005 10^9 *cells per liter
Standard Deviation 0.1256
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils: change at week 4
0.032 10^9 *cells per liter
Standard Deviation 0.1813
0.018 10^9 *cells per liter
Standard Deviation 0.1120
0.008 10^9 *cells per liter
Standard Deviation 0.1325
-0.019 10^9 *cells per liter
Standard Deviation 0.1102
-0.032 10^9 *cells per liter
Standard Deviation 0.1040
-0.012 10^9 *cells per liter
Standard Deviation 0.0832
0.042 10^9 *cells per liter
Standard Deviation 0.1076
-0.012 10^9 *cells per liter
Standard Deviation 0.1499
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils: change at week 6
0.002 10^9 *cells per liter
Standard Deviation 0.0935
0.029 10^9 *cells per liter
Standard Deviation 0.1090
-0.025 10^9 *cells per liter
Standard Deviation 0.1351
0.018 10^9 *cells per liter
Standard Deviation 0.1387
-0.027 10^9 *cells per liter
Standard Deviation 0.1125
-0.007 10^9 *cells per liter
Standard Deviation 0.1025
-0.001 10^9 *cells per liter
Standard Deviation 0.0812
-0.022 10^9 *cells per liter
Standard Deviation 0.1415
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Eosinophils: change at follow-up visit
0.022 10^9 *cells per liter
Standard Deviation 0.1461
0.006 10^9 *cells per liter
Standard Deviation 0.0931
-0.023 10^9 *cells per liter
Standard Deviation 0.1196
-0.004 10^9 *cells per liter
Standard Deviation 0.1810
0.008 10^9 *cells per liter
Standard Deviation 0.1270
-0.008 10^9 *cells per liter
Standard Deviation 0.2483
0.048 10^9 *cells per liter
Standard Deviation 0.1520
-0.011 10^9 *cells per liter
Standard Deviation 0.1945
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes: change at week 1
0.006 10^9 *cells per liter
Standard Deviation 0.1796
0.030 10^9 *cells per liter
Standard Deviation 0.0855
0.030 10^9 *cells per liter
Standard Deviation 0.0987
0.009 10^9 *cells per liter
Standard Deviation 0.0879
0.019 10^9 *cells per liter
Standard Deviation 0.1055
0.006 10^9 *cells per liter
Standard Deviation 0.0877
0.051 10^9 *cells per liter
Standard Deviation 0.1244
0.011 10^9 *cells per liter
Standard Deviation 0.1195
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes: change at week 2
-0.006 10^9 *cells per liter
Standard Deviation 0.1509
0.016 10^9 *cells per liter
Standard Deviation 0.1343
-0.003 10^9 *cells per liter
Standard Deviation 0.0724
-0.014 10^9 *cells per liter
Standard Deviation 0.1055
0.017 10^9 *cells per liter
Standard Deviation 0.0865
0.013 10^9 *cells per liter
Standard Deviation 0.0983
0.049 10^9 *cells per liter
Standard Deviation 0.1471
0.025 10^9 *cells per liter
Standard Deviation 0.1496
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes: change at week 4
-0.035 10^9 *cells per liter
Standard Deviation 0.1904
0.030 10^9 *cells per liter
Standard Deviation 0.1212
0.013 10^9 *cells per liter
Standard Deviation 0.1234
-0.003 10^9 *cells per liter
Standard Deviation 0.1092
0.009 10^9 *cells per liter
Standard Deviation 0.0986
0.035 10^9 *cells per liter
Standard Deviation 0.0978
0.007 10^9 *cells per liter
Standard Deviation 0.1008
0.038 10^9 *cells per liter
Standard Deviation 0.1331
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes: change at week 6
0.017 10^9 *cells per liter
Standard Deviation 0.1777
0.017 10^9 *cells per liter
Standard Deviation 0.1069
-0.025 10^9 *cells per liter
Standard Deviation 0.1191
-0.005 10^9 *cells per liter
Standard Deviation 0.1021
-0.019 10^9 *cells per liter
Standard Deviation 0.0726
0.004 10^9 *cells per liter
Standard Deviation 0.0847
0.003 10^9 *cells per liter
Standard Deviation 0.1097
-0.012 10^9 *cells per liter
Standard Deviation 0.1200
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Monocytes: change at follow-up visit
0.011 10^9 *cells per liter
Standard Deviation 0.1806
0.021 10^9 *cells per liter
Standard Deviation 0.0824
0.030 10^9 *cells per liter
Standard Deviation 0.1467
0.005 10^9 *cells per liter
Standard Deviation 0.0887
0.021 10^9 *cells per liter
Standard Deviation 0.0739
0.018 10^9 *cells per liter
Standard Deviation 0.1047
0.029 10^9 *cells per liter
Standard Deviation 0.1788
-0.006 10^9 *cells per liter
Standard Deviation 0.1282

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=28 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=27 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=31 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=32 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=29 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=24 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=30 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=32 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Lipids Profile Values at Week 6
HDL cholesterol
-2.8 Microgram per deciliter
Standard Deviation 6.65
0.1 Microgram per deciliter
Standard Deviation 5.34
-1.3 Microgram per deciliter
Standard Deviation 7.74
2.7 Microgram per deciliter
Standard Deviation 8.33
1.9 Microgram per deciliter
Standard Deviation 11.18
0.0 Microgram per deciliter
Standard Deviation 6.76
1.2 Microgram per deciliter
Standard Deviation 4.12
0.3 Microgram per deciliter
Standard Deviation 8.56
Change From Baseline in Lipids Profile Values at Week 6
Triglycerides
3.3 Microgram per deciliter
Standard Deviation 38.84
-4.2 Microgram per deciliter
Standard Deviation 59.30
-6.5 Microgram per deciliter
Standard Deviation 37.30
1.8 Microgram per deciliter
Standard Deviation 60.74
-18.9 Microgram per deciliter
Standard Deviation 56.78
-8.1 Microgram per deciliter
Standard Deviation 50.41
-7.0 Microgram per deciliter
Standard Deviation 58.36
-4.4 Microgram per deciliter
Standard Deviation 55.66
Change From Baseline in Lipids Profile Values at Week 6
Cholesterol
-3.5 Microgram per deciliter
Standard Deviation 16.39
-5.6 Microgram per deciliter
Standard Deviation 27.59
-12.8 Microgram per deciliter
Standard Deviation 20.53
6.8 Microgram per deciliter
Standard Deviation 24.09
-10.4 Microgram per deciliter
Standard Deviation 30.79
-0.2 Microgram per deciliter
Standard Deviation 18.70
5.3 Microgram per deciliter
Standard Deviation 30.58
-0.9 Microgram per deciliter
Standard Deviation 19.86
Change From Baseline in Lipids Profile Values at Week 6
LDL Cholesterol
-3.4 Microgram per deciliter
Standard Deviation 14.45
-6.3 Microgram per deciliter
Standard Deviation 25.28
-12.1 Microgram per deciliter
Standard Deviation 16.44
2.1 Microgram per deciliter
Standard Deviation 20.13
-11.0 Microgram per deciliter
Standard Deviation 29.06
-0.8 Microgram per deciliter
Standard Deviation 14.48
4.4 Microgram per deciliter
Standard Deviation 23.55
-1.1 Microgram per deciliter
Standard Deviation 16.29

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=28 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=27 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=31 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=32 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=29 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=24 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=30 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=32 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6
0.0 Ratio
Standard Deviation 0.31
-0.1 Ratio
Standard Deviation 0.48
-0.2 Ratio
Standard Deviation 0.40
-0.0 Ratio
Standard Deviation 0.32
-0.3 Ratio
Standard Deviation 0.77
-0.0 Ratio
Standard Deviation 0.35
0.0 Ratio
Standard Deviation 0.46
-0.0 Ratio
Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline, Weeks 2 and 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Baseline
66.8 Beats per minute
Standard Deviation 11.45
66.9 Beats per minute
Standard Deviation 9.33
68.4 Beats per minute
Standard Deviation 14.66
64.9 Beats per minute
Standard Deviation 9.05
64.9 Beats per minute
Standard Deviation 12.26
66.9 Beats per minute
Standard Deviation 12.03
68.2 Beats per minute
Standard Deviation 12.11
68.1 Beats per minute
Standard Deviation 12.48
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Change at week 2
0.7 Beats per minute
Standard Deviation 10.05
-0.5 Beats per minute
Standard Deviation 8.03
-1.8 Beats per minute
Standard Deviation 11.53
-0.6 Beats per minute
Standard Deviation 7.88
1.9 Beats per minute
Standard Deviation 8.01
2.2 Beats per minute
Standard Deviation 8.76
1.7 Beats per minute
Standard Deviation 9.13
1.7 Beats per minute
Standard Deviation 12.52
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Change at week 6
0.3 Beats per minute
Standard Deviation 6.19
-1.1 Beats per minute
Standard Deviation 7.65
-1.7 Beats per minute
Standard Deviation 9.06
0.8 Beats per minute
Standard Deviation 8.53
-0.3 Beats per minute
Standard Deviation 8.46
-0.8 Beats per minute
Standard Deviation 8.23
0.5 Beats per minute
Standard Deviation 8.76
-0.4 Beats per minute
Standard Deviation 12.06

SECONDARY outcome

Timeframe: Baseline, Weeks 2 and 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
PR interval: change at week 2
0.8 Milliseconds
Standard Deviation 14.41
-0.9 Milliseconds
Standard Deviation 15.92
0.7 Milliseconds
Standard Deviation 18.54
0.3 Milliseconds
Standard Deviation 10.13
1.1 Milliseconds
Standard Deviation 14.42
6.0 Milliseconds
Standard Deviation 14.79
1.2 Milliseconds
Standard Deviation 16.06
2.1 Milliseconds
Standard Deviation 7.98
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
PR interval: change at week 6
-0.9 Milliseconds
Standard Deviation 10.16
-0.1 Milliseconds
Standard Deviation 13.81
2.8 Milliseconds
Standard Deviation 19.66
2.9 Milliseconds
Standard Deviation 13.63
3.5 Milliseconds
Standard Deviation 21.88
4.0 Milliseconds
Standard Deviation 14.56
6.5 Milliseconds
Standard Deviation 19.15
5.7 Milliseconds
Standard Deviation 16.11
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QRS interval: baseline
92.5 Milliseconds
Standard Deviation 9.36
91.5 Milliseconds
Standard Deviation 9.71
91.1 Milliseconds
Standard Deviation 9.29
93.0 Milliseconds
Standard Deviation 11.13
93.1 Milliseconds
Standard Deviation 8.69
92.2 Milliseconds
Standard Deviation 13.00
92.4 Milliseconds
Standard Deviation 13.30
91.5 Milliseconds
Standard Deviation 11.68
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QRS interval: change at week 2
-1.4 Milliseconds
Standard Deviation 8.02
-0.4 Milliseconds
Standard Deviation 5.34
-1.3 Milliseconds
Standard Deviation 3.46
-0.8 Milliseconds
Standard Deviation 5.64
0.1 Milliseconds
Standard Deviation 4.79
1.5 Milliseconds
Standard Deviation 9.29
0.2 Milliseconds
Standard Deviation 8.07
1.0 Milliseconds
Standard Deviation 5.63
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QRS interval: change at week 6
-1.9 Milliseconds
Standard Deviation 6.55
1.4 Milliseconds
Standard Deviation 5.62
-0.5 Milliseconds
Standard Deviation 4.76
-0.9 Milliseconds
Standard Deviation 4.04
-1.3 Milliseconds
Standard Deviation 4.00
0.9 Milliseconds
Standard Deviation 6.37
0.6 Milliseconds
Standard Deviation 5.49
0.7 Milliseconds
Standard Deviation 5.67
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QTCF interval: baseline
407.7 Milliseconds
Standard Deviation 17.78
397.9 Milliseconds
Standard Deviation 15.98
403.8 Milliseconds
Standard Deviation 22.43
408.5 Milliseconds
Standard Deviation 18.42
401.0 Milliseconds
Standard Deviation 16.29
403.0 Milliseconds
Standard Deviation 16.65
397.7 Milliseconds
Standard Deviation 17.05
405.0 Milliseconds
Standard Deviation 20.38
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QTCF interval: change at week 2
-5.7 Milliseconds
Standard Deviation 11.86
-1.5 Milliseconds
Standard Deviation 13.70
-3.9 Milliseconds
Standard Deviation 15.60
2.6 Milliseconds
Standard Deviation 16.20
-0.6 Milliseconds
Standard Deviation 12.75
1.4 Milliseconds
Standard Deviation 15.56
2.4 Milliseconds
Standard Deviation 10.32
-4.6 Milliseconds
Standard Deviation 15.43
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QTCF interval: change at week 6
-4.1 Milliseconds
Standard Deviation 14.61
-0.5 Milliseconds
Standard Deviation 14.93
-1.9 Milliseconds
Standard Deviation 14.37
0.3 Milliseconds
Standard Deviation 17.19
-1.4 Milliseconds
Standard Deviation 14.93
4.6 Milliseconds
Standard Deviation 14.27
2.0 Milliseconds
Standard Deviation 11.94
-0.2 Milliseconds
Standard Deviation 9.67
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QT interval: baseline
395.2 Milliseconds
Standard Deviation 31.53
385.3 Milliseconds
Standard Deviation 23.64
388.8 Milliseconds
Standard Deviation 33.66
401.0 Milliseconds
Standard Deviation 25.23
392.0 Milliseconds
Standard Deviation 27.36
390.9 Milliseconds
Standard Deviation 24.87
383.8 Milliseconds
Standard Deviation 30.79
390.6 Milliseconds
Standard Deviation 32.43
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QT interval: change at week 2
-5.9 Milliseconds
Standard Deviation 23.16
-1.3 Milliseconds
Standard Deviation 17.73
-1.1 Milliseconds
Standard Deviation 19.31
3.5 Milliseconds
Standard Deviation 21.06
-4.5 Milliseconds
Standard Deviation 15.75
1.2 Milliseconds
Standard Deviation 24.03
-2.3 Milliseconds
Standard Deviation 18.69
-4.6 Milliseconds
Standard Deviation 25.76
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
QT interval: change at week 6
-4.9 Milliseconds
Standard Deviation 19.54
1.3 Milliseconds
Standard Deviation 18.11
0.9 Milliseconds
Standard Deviation 16.11
-4.1 Milliseconds
Standard Deviation 23.42
-0.9 Milliseconds
Standard Deviation 20.12
7.8 Milliseconds
Standard Deviation 24.11
-1.4 Milliseconds
Standard Deviation 20.47
4.0 Milliseconds
Standard Deviation 27.74
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
PR interval: baseline
161.9 Milliseconds
Standard Deviation 23.30
160.2 Milliseconds
Standard Deviation 24.01
161.4 Milliseconds
Standard Deviation 27.59
162.5 Milliseconds
Standard Deviation 22.04
160.7 Milliseconds
Standard Deviation 24.20
156.4 Milliseconds
Standard Deviation 22.65
157.9 Milliseconds
Standard Deviation 23.55
157.8 Milliseconds
Standard Deviation 23.15

SECONDARY outcome

Timeframe: Baseline, Weeks 2 and 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.

Blood pressure included supine and sitting systolic and diastolic BP.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=25 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=26 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=29 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=22 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=23 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=26 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=23 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=25 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Supine systolic BP: Baseline
123.3 Millimeters of mercury
Standard Deviation 12.01
123.2 Millimeters of mercury
Standard Deviation 12.35
123.0 Millimeters of mercury
Standard Deviation 13.89
119.7 Millimeters of mercury
Standard Deviation 9.08
122.6 Millimeters of mercury
Standard Deviation 12.76
123.1 Millimeters of mercury
Standard Deviation 12.40
117.1 Millimeters of mercury
Standard Deviation 14.07
118.9 Millimeters of mercury
Standard Deviation 12.43
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Supine systolic BP: change at week 2
0.3 Millimeters of mercury
Standard Deviation 11.55
-1.4 Millimeters of mercury
Standard Deviation 9.61
0.5 Millimeters of mercury
Standard Deviation 14.73
2.3 Millimeters of mercury
Standard Deviation 6.99
-0.3 Millimeters of mercury
Standard Deviation 10.25
-0.3 Millimeters of mercury
Standard Deviation 8.02
3.5 Millimeters of mercury
Standard Deviation 13.65
2.9 Millimeters of mercury
Standard Deviation 8.48
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Supine systolic BP: change at week 6
-0.2 Millimeters of mercury
Standard Deviation 12.98
1.1 Millimeters of mercury
Standard Deviation 10.06
2.0 Millimeters of mercury
Standard Deviation 14.05
0.2 Millimeters of mercury
Standard Deviation 9.13
-3.4 Millimeters of mercury
Standard Deviation 11.02
-1.4 Millimeters of mercury
Standard Deviation 10.49
2.1 Millimeters of mercury
Standard Deviation 12.41
0.6 Millimeters of mercury
Standard Deviation 10.31
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Sitting systolic BP: Baseline
117.7 Millimeters of mercury
Standard Deviation 13.05
120.8 Millimeters of mercury
Standard Deviation 10.26
120.2 Millimeters of mercury
Standard Deviation 12.43
116.9 Millimeters of mercury
Standard Deviation 17.76
124.6 Millimeters of mercury
Standard Deviation 11.25
119.4 Millimeters of mercury
Standard Deviation 12.96
122.9 Millimeters of mercury
Standard Deviation 15.25
125.6 Millimeters of mercury
Standard Deviation 12.21
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Sitting systolic BP: change at week 2
1.3 Millimeters of mercury
Standard Deviation 12.12
-1.9 Millimeters of mercury
Standard Deviation 11.86
-3.9 Millimeters of mercury
Standard Deviation 14.54
1.3 Millimeters of mercury
Standard Deviation 13.59
-2.4 Millimeters of mercury
Standard Deviation 11.76
-3.1 Millimeters of mercury
Standard Deviation 10.46
1.1 Millimeters of mercury
Standard Deviation 9.81
4.4 Millimeters of mercury
Standard Deviation 11.68
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Sitting systolic BP: change at week 6
0.6 Millimeters of mercury
Standard Deviation 12.24
-7.5 Millimeters of mercury
Standard Deviation 8.67
-9.4 Millimeters of mercury
Standard Deviation 8.95
1.0 Millimeters of mercury
Standard Deviation 14.63
-8.4 Millimeters of mercury
Standard Deviation 10.81
-0.6 Millimeters of mercury
Standard Deviation 14.40
-3.6 Millimeters of mercury
Standard Deviation 8.37
-1.5 Millimeters of mercury
Standard Deviation 5.80
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Supine diastolic BP: Baseline
77.7 Millimeters of mercury
Standard Deviation 9.28
75.2 Millimeters of mercury
Standard Deviation 8.79
78.8 Millimeters of mercury
Standard Deviation 8.39
74.5 Millimeters of mercury
Standard Deviation 8.26
75.9 Millimeters of mercury
Standard Deviation 8.78
77.5 Millimeters of mercury
Standard Deviation 8.71
74.4 Millimeters of mercury
Standard Deviation 8.20
73.7 Millimeters of mercury
Standard Deviation 8.59
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Supine diastolic BP: change at week 2
0.5 Millimeters of mercury
Standard Deviation 7.51
0.6 Millimeters of mercury
Standard Deviation 6.47
-0.4 Millimeters of mercury
Standard Deviation 8.50
1.6 Millimeters of mercury
Standard Deviation 10.33
1.2 Millimeters of mercury
Standard Deviation 8.32
-2.8 Millimeters of mercury
Standard Deviation 6.69
1.6 Millimeters of mercury
Standard Deviation 8.89
1.4 Millimeters of mercury
Standard Deviation 7.74
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Supine diastolic BP: change at week 6
-2.5 Millimeters of mercury
Standard Deviation 7.69
1.5 Millimeters of mercury
Standard Deviation 7.61
-0.7 Millimeters of mercury
Standard Deviation 8.32
0.5 Millimeters of mercury
Standard Deviation 7.96
-0.9 Millimeters of mercury
Standard Deviation 10.65
-1.6 Millimeters of mercury
Standard Deviation 6.22
1.9 Millimeters of mercury
Standard Deviation 9.72
0.5 Millimeters of mercury
Standard Deviation 6.32
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Sitting diastolic BP: Baseline
76.5 Millimeters of mercury
Standard Deviation 9.28
80.1 Millimeters of mercury
Standard Deviation 6.76
77.8 Millimeters of mercury
Standard Deviation 10.02
69.6 Millimeters of mercury
Standard Deviation 11.48
80.9 Millimeters of mercury
Standard Deviation 8.21
75.1 Millimeters of mercury
Standard Deviation 5.77
77.1 Millimeters of mercury
Standard Deviation 12.00
80.3 Millimeters of mercury
Standard Deviation 7.83
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Sitting diastolic BP: change at week 2
-1.6 Millimeters of mercury
Standard Deviation 8.49
0.7 Millimeters of mercury
Standard Deviation 7.93
0.0 Millimeters of mercury
Standard Deviation 9.44
1.6 Millimeters of mercury
Standard Deviation 12.00
-2.9 Millimeters of mercury
Standard Deviation 10.77
1.7 Millimeters of mercury
Standard Deviation 8.20
4.5 Millimeters of mercury
Standard Deviation 5.80
-1.2 Millimeters of mercury
Standard Deviation 6.49
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Sitting diastolic BP: change at week 6
0.8 Millimeters of mercury
Standard Deviation 9.90
0.0 Millimeters of mercury
Standard Deviation 5.79
-1.6 Millimeters of mercury
Standard Deviation 11.97
1.1 Millimeters of mercury
Standard Deviation 15.61
-5.3 Millimeters of mercury
Standard Deviation 9.27
-2.8 Millimeters of mercury
Standard Deviation 12.60
-0.3 Millimeters of mercury
Standard Deviation 7.89
0.4 Millimeters of mercury
Standard Deviation 8.41

SECONDARY outcome

Timeframe: Baseline, Weeks 2 and 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Baseline
69.6 Beats per minute
Standard Deviation 12.58
69.5 Beats per minute
Standard Deviation 9.82
72.9 Beats per minute
Standard Deviation 14.30
67.9 Beats per minute
Standard Deviation 9.31
68.8 Beats per minute
Standard Deviation 11.76
69.4 Beats per minute
Standard Deviation 11.15
70.1 Beats per minute
Standard Deviation 11.18
68.2 Beats per minute
Standard Deviation 9.59
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Change at week 2
0.5 Beats per minute
Standard Deviation 10.41
0.2 Beats per minute
Standard Deviation 8.11
-2.5 Beats per minute
Standard Deviation 9.66
1.1 Beats per minute
Standard Deviation 9.13
0.5 Beats per minute
Standard Deviation 6.54
3.7 Beats per minute
Standard Deviation 9.47
2.8 Beats per minute
Standard Deviation 8.28
4.1 Beats per minute
Standard Deviation 9.16
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Change at week 6
2.1 Beats per minute
Standard Deviation 10.59
0.3 Beats per minute
Standard Deviation 8.04
-1.4 Beats per minute
Standard Deviation 11.90
0.9 Beats per minute
Standard Deviation 9.71
1.8 Beats per minute
Standard Deviation 8.73
4.1 Beats per minute
Standard Deviation 6.76
0.5 Beats per minute
Standard Deviation 9.12
1.8 Beats per minute
Standard Deviation 8.64

SECONDARY outcome

Timeframe: Baseline, Weeks 2 and 6

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Baseline
36.5 Degree Celsius
Standard Deviation 0.33
36.5 Degree Celsius
Standard Deviation 0.43
36.6 Degree Celsius
Standard Deviation 0.44
36.6 Degree Celsius
Standard Deviation 0.33
36.5 Degree Celsius
Standard Deviation 0.37
36.5 Degree Celsius
Standard Deviation 0.29
36.6 Degree Celsius
Standard Deviation 0.41
36.6 Degree Celsius
Standard Deviation 0.29
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Change at week 2
-0.1 Degree Celsius
Standard Deviation 0.41
-0.1 Degree Celsius
Standard Deviation 0.30
0.0 Degree Celsius
Standard Deviation 0.38
-0.0 Degree Celsius
Standard Deviation 0.43
0.1 Degree Celsius
Standard Deviation 0.35
-0.0 Degree Celsius
Standard Deviation 0.38
0.0 Degree Celsius
Standard Deviation 0.34
0.0 Degree Celsius
Standard Deviation 0.41
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Change at week 6
-0.0 Degree Celsius
Standard Deviation 0.40
-0.0 Degree Celsius
Standard Deviation 0.29
0.0 Degree Celsius
Standard Deviation 0.38
0.1 Degree Celsius
Standard Deviation 0.32
0.0 Degree Celsius
Standard Deviation 0.29
0.1 Degree Celsius
Standard Deviation 0.50
0.0 Degree Celsius
Standard Deviation 0.37
-0.0 Degree Celsius
Standard Deviation 0.46

SECONDARY outcome

Timeframe: Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)

Population: Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.

Local tolerability skin assessments were performed by the investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, slight glazed appearance); grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology) grade 3=severe (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent \[if still in place\]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent \[if still in place\]). Higher grades indicated worsening of condition. Only those categories in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure
Vehicle Cream Once Daily (QD)
n=37 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 Participants
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 Participants
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 Participants
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Day 1: tolerability before: none
35 Participants
35 Participants
31 Participants
33 Participants
36 Participants
35 Participants
34 Participants
36 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Day 1: tolerability before: mild
0 Participants
0 Participants
1 Participants
3 Participants
0 Participants
1 Participants
2 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Day 1: tolerability before: moderate
2 Participants
2 Participants
4 Participants
1 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Day 1: tolerability after: none
33 Participants
36 Participants
30 Participants
33 Participants
35 Participants
34 Participants
32 Participants
33 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Day 1: tolerability after: mild
1 Participants
0 Participants
1 Participants
2 Participants
0 Participants
2 Participants
4 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Day 1: tolerability after: moderate
1 Participants
1 Participants
3 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 1: tolerability before: none
31 Participants
28 Participants
28 Participants
30 Participants
30 Participants
30 Participants
33 Participants
33 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 1: tolerability before: mild
1 Participants
2 Participants
3 Participants
3 Participants
3 Participants
1 Participants
1 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 1: tolerability before: moderate
2 Participants
0 Participants
3 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 1: tolerability after: none
28 Participants
29 Participants
29 Participants
30 Participants
28 Participants
27 Participants
32 Participants
31 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 1: tolerability after: mild
2 Participants
2 Participants
2 Participants
3 Participants
2 Participants
3 Participants
1 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 1: tolerability after: moderate
2 Participants
0 Participants
2 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 2: tolerability before: none
29 Participants
28 Participants
26 Participants
30 Participants
30 Participants
23 Participants
31 Participants
33 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 2: tolerability before: mild
3 Participants
2 Participants
2 Participants
2 Participants
1 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 2: tolerability before: moderate
1 Participants
0 Participants
3 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 2: tolerability after: none
28 Participants
26 Participants
29 Participants
31 Participants
29 Participants
23 Participants
32 Participants
30 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 2: tolerability after: mild
1 Participants
3 Participants
2 Participants
1 Participants
1 Participants
2 Participants
0 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 2: tolerability after: moderate
1 Participants
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 4: tolerability before: none
27 Participants
26 Participants
30 Participants
30 Participants
30 Participants
24 Participants
31 Participants
31 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 4: tolerability before: mild
0 Participants
2 Participants
2 Participants
2 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 4: tolerability before: moderate
1 Participants
0 Participants
1 Participants
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 4: tolerability after: none
24 Participants
26 Participants
30 Participants
30 Participants
29 Participants
24 Participants
31 Participants
30 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 4: tolerability after: mild
1 Participants
2 Participants
2 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 4: tolerability after: moderate
1 Participants
0 Participants
0 Participants
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 6: tolerability before: none
26 Participants
25 Participants
29 Participants
30 Participants
30 Participants
21 Participants
30 Participants
32 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 6: tolerability before: mild
1 Participants
1 Participants
2 Participants
1 Participants
0 Participants
1 Participants
0 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 6: tolerability before: moderate
0 Participants
0 Participants
2 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 6: tolerability after: none
25 Participants
24 Participants
28 Participants
29 Participants
29 Participants
22 Participants
30 Participants
30 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 6: tolerability after: mild
0 Participants
1 Participants
3 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Week 6: tolerability after: moderate
0 Participants
0 Participants
1 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Early termination:tolerability: none
6 Participants
5 Participants
3 Participants
2 Participants
2 Participants
9 Participants
2 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Early termination:tolerability: mild
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Early termination:tolerability: moderate
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Early termination:tolerability: severe
1 Participants
1 Participants
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Follow Up: tolerability: none
22 Participants
26 Participants
25 Participants
25 Participants
28 Participants
25 Participants
26 Participants
28 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Follow Up: tolerability: mild
1 Participants
0 Participants
2 Participants
0 Participants
0 Participants
1 Participants
1 Participants
1 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Follow Up: tolerability: moderate
1 Participants
0 Participants
1 Participants
4 Participants
1 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Follow Up: tolerability: severe
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

Adverse Events

Vehicle Cream Once Daily (QD)

Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths

PF-06700841 0.1% Cream QD

Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths

PF-06700841 0.3% Cream QD

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

PF-06700841 1.0% Cream QD

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

PF-06700841 3.0% Cream QD

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Vehicle Cream Twice Daily (BID)

Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths

PF-06700841 0.3% Cream BID

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

PF-06700841 1.0% Cream BID

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Vehicle Cream Once Daily (QD)
n=37 participants at risk
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.1% Cream QD
n=37 participants at risk
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream QD
n=36 participants at risk
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream QD
n=37 participants at risk
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 3.0% Cream QD
n=36 participants at risk
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Vehicle Cream Twice Daily (BID)
n=36 participants at risk
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 0.3% Cream BID
n=36 participants at risk
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
PF-06700841 1.0% Cream BID
n=37 participants at risk
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Infections and infestations
Pharyngitis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Eye disorders
Swelling of eyelid
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Eye disorders
Ulcerative keratitis
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Gastrointestinal disorders
Dyspepsia
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Gastrointestinal disorders
Nausea
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Administration site warmth
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Application site acne
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Application site erythema
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.6%
2/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Application site pain
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Application site pruritus
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
8.3%
3/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Chills
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Injection site pain
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Oedema peripheral
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Pain
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Pyrexia
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
General disorders
Vessel puncture site haematoma
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Immune system disorders
Allergy to arthropod sting
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Immune system disorders
Cockroach allergy
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Immune system disorders
Mite allergy
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Bacterial allergy
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Bronchitis
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Conjunctivitis
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Cystitis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Eczema infected
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Folliculitis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Furuncle
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Gastroenteritis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Gastroenteritis viral
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Gingivitis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Herpes simplex
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Influenza
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.4%
2/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Kaposi's varicelliform eruption
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Laryngitis
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Nasopharyngitis
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.4%
2/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.6%
2/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
8.1%
3/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
11.1%
4/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.6%
2/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.6%
2/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.4%
2/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Oral herpes
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Rhinitis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Skin infection
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Staphylococcal skin infection
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Tonsillitis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Upper respiratory tract infection
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Urinary tract infection
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.6%
2/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.4%
2/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Vaginal infection
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Viral infection
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Viral pharyngitis
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Viral rhinitis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Injury, poisoning and procedural complications
Limb injury
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Alanine aminotransferase increased
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Aspartate aminotransferase increased
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Blood bilirubin increased
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Blood creatine phosphokinase increased
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Blood glucose increased
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Electrocardiogram T wave inversion
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Glomerular filtration rate decreased
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Lipids abnormal
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Neutrophil count decreased
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Investigations
Pregnancy test positive
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Nervous system disorders
Burning sensation
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Nervous system disorders
Headache
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Pregnancy, puerperium and perinatal conditions
Pregnancy
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Psychiatric disorders
Insomnia
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Renal and urinary disorders
Dysuria
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Reproductive system and breast disorders
Menstruation irregular
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Reproductive system and breast disorders
Metrorrhagia
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.6%
2/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.4%
2/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Acne
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Dermatitis atopic
8.1%
3/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
8.1%
3/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
8.3%
3/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
5.4%
2/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Eczema
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Erythema
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Granuloma annulare
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Photosensitivity reaction
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Pruritus
5.4%
2/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Skin discolouration
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Skin irritation
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Skin and subcutaneous tissue disorders
Solar urticaria
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Vascular disorders
Haematoma
2.7%
1/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Immune system disorders
Allergy to animal
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
2.8%
1/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/36 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
0.00%
0/37 • Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

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