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Clinical Trial Results:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of PF-04965842 Monotherapy in Subjects Aged 12 Years and Older, With Moderate to Severe Atopic Dermatitis

Summary
EudraCT number	2018-001136-21
Trial protocol	BG HU CZ GB DE PL LV
Global end of trial date	13 Aug 2019

Results information
Results version number	v1(current)
This version publication date	07 Feb 2020
First version publication date	07 Feb 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

B7451013

ISRCTN number

US NCT number

NCT03575871

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

13 Aug 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Aug 2019

Was the trial ended prematurely?

Main objective of the trial

To assess the efficacy of PF-04965842 compared with placebo in subjects aged 12 years and older with moderate to severe AD

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 Jun 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 32

Country: Number of subjects enrolled

Bulgaria: 22

Country: Number of subjects enrolled

Canada: 23

Country: Number of subjects enrolled

China: 24

Country: Number of subjects enrolled

Czech Republic: 14

Country: Number of subjects enrolled

Germany: 39

Country: Number of subjects enrolled

Hungary: 13

Country: Number of subjects enrolled

Japan: 44

Country: Number of subjects enrolled

Korea, Republic of: 35

Country: Number of subjects enrolled

Latvia: 12

Country: Number of subjects enrolled

Poland: 52

Country: Number of subjects enrolled

United Kingdom: 23

Country: Number of subjects enrolled

United States: 58

Worldwide total number of subjects

391

EEA total number of subjects

175

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

332

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects with age greater than or equal to (>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of >=40 kilograms were enrolled in the study. Eligible subjects had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.

Screening details

This study was conducted from 29-June-2018 to 13-Aug-2019 at 106 sites in 13 countries.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

PF-04965842 100 mg

Arm description

Subjects were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

Arm type

Experimental

Investigational medicinal product name

Abrocitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received 100 milligram (mg) tablet orally once daily for 12 weeks

PF-04965842 200 mg

Arm description

Subjects were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

Arm type

Experimental

Investigational medicinal product name

Abrocitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks.

Placebo

Arm description

Subjects were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks.

Number of subjects in period 1	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Started	158	155	78
Completed	137	141	52
Not completed	21	14	26
Adverse event, serious fatal	1	-	-
Consent withdrawn by subject	6	1	9
Adverse event, non-fatal	5	5	8
Protocol Deviation	1	1	1
Other than specified	2	2	-
Lost to follow-up	1	1	1
Lack of efficacy	5	4	7

Baseline characteristics

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Reporting group title

PF-04965842 100 mg

Reporting group description

Reporting group title

PF-04965842 200 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo	Total
Number of subjects	158	155	78	391
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	17	15	8	40
Adults (18-64 years)	130	133	69	332
From 65-84 years	11	7	1	19
85 years and over	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	37.4 ± 15.8	33.5 ± 14.7	33.4 ± 13.8	-
Sex: Female, Male
Units: Subjects
Female	64	67	31	162
Male	94	88	47	229
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	3	4	2	9
Not Hispanic or Latino	154	150	73	377
Unknown or Not Reported	1	1	3	5
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0
Asian	46	54	29	129
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	9	6	6	21
White	101	91	40	232
More than one race	1	2	1	4
Unknown or Not Reported	1	2	2	5

End points

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Reporting group title

PF-04965842 100 mg

Reporting group description

Reporting group title

PF-04965842 200 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Primary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

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End point title

Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

End point description

IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 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; 4=severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study drug. Number of Subjects Analysed signifies subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Week 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	155	155	77
Units: percentage of subjects
number (confidence interval 95%)	28.4 (21.3 to 35.5)	38.1 (30.4 to 45.7)	9.1 (2.7 to 15.5)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0008 ^[1]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

19.3

Confidence interval

level

95%

sides

2-sided

lower limit

9.6

upper limit

Notes
[1] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

28.7

Confidence interval

level

95%

sides

2-sided

lower limit

18.6

upper limit

38.8

Notes
[2] - P-value was adjusted by randomization strata (baseline disease severity and age category).

Primary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12

Top of page

End point title

Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12

End point description

EASI evaluates severity of subject's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in 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. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Week 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	155	154	77
Units: percentage of subjects
number (confidence interval 95%)	44.5 (36.7 to 52.3)	61.0 (53.3 to 68.7)	10.4 (3.6 to 17.2)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[3]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

33.9

Confidence interval

level

95%

sides

2-sided

lower limit

23.3

upper limit

44.4

Notes
[3] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

231

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[4]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

50.5

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

60.9

Notes
[4] - P-value was adjusted by randomization strata (baseline disease severity and age category)

Secondary: Percentage of Subjects who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12

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End point title

Percentage of Subjects who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12

End point description

Subjects were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analyzed” signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	156	153	76
Units: percentage of subjects
number (confidence interval 95%)
Week 2	23.1 (16.5 to 29.7)	35.3 (27.7 to 42.9)	3.9 (0.0 to 8.3)
Week 4	31.4 (24.1 to 38.7)	50.3 (42.4 to 58.2)	3.9 (0.0 to 8.3)
Week 8	39.1 (31.4 to 46.8)	51.6 (43.7 to 59.6)	11.8 (4.6 to 19.1)
Week 12	39.7 (32.1 to 47.4)	49.0 (41.1 to 56.9)	10.5 (3.6 to 17.4)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002 ^[5]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

19.2

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

27.4

Notes
[5] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

229

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[6]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

31.2

Confidence interval

level

95%

sides

2-sided

lower limit

22.3

upper limit

40.2

Notes
[6] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[7]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

27.5

Confidence interval

level

95%

sides

2-sided

lower limit

18.9

upper limit

36.2

Notes
[7] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

229

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[8]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

46.4

Confidence interval

level

95%

sides

2-sided

lower limit

37.2

upper limit

55.7

Notes
[8] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[9]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

27.4

Confidence interval

level

95%

sides

2-sided

lower limit

16.8

upper limit

Notes
[9] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

229

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[10]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

39.8

Confidence interval

level

95%

sides

2-sided

lower limit

28.9

upper limit

50.6

Notes
[10] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[11]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

29.3

Confidence interval

level

95%

sides

2-sided

lower limit

18.9

upper limit

39.6

Notes
[11] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

229

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[12]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

38.6

Confidence interval

level

95%

sides

2-sided

lower limit

28.1

upper limit

49.1

Notes
[12] - P-value was adjusted by randomization strata (baseline disease severity and age category).

Secondary: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12

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End point title

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12

End point description

PSAAD is a daily subject reported symptom electronic diary. Subjects rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Subject had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	156	155	77
Units: units on a scale
least squares mean (confidence interval 95%)	-2.4 (-2.8 to -2.1)	-3.0 (-3.3 to -2.7)	-0.8 (-1.3 to -0.3)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

-1.1

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-2.8

upper limit

-1.6

Secondary: Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus

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End point title

Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus

End point description

Subjects were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline up to Day 15

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	90 ^[13]	110 ^[14]	20 ^[15]
Units: days
median (inter-quartile range (Q1-Q3))	58.0 (11.0 to 99999)	29.0 (8.0 to 87.0)	112.0 (58.0 to 99999)

Notes
[13] - Here, '99999' indicate that upper limit was not evaluable as too few events were observed.
[14] - Here, '99999' indicate that upper limit was not evaluable as too few events were observed.
[15] - Here, '99999' indicate that upper limit was not evaluable as too few events were observed.

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8

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End point title

Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8

End point description

EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in 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. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, "n" signifies subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4 and 8

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n=157, 152, 76)	10.2 (5.5 to 14.9)	24.3 (17.5 to 31.2)	1.3 (0.0 to 3.9)
Week 4 (n=155, 153, 77)	26.5 (19.5 to 33.4)	51.0 (43.1 to 58.9)	6.5 (1.0 to 12.0)
Week 8 (n=157, 154, 78)	43.3 (35.6 to 51.1)	60.4 (52.7 to 68.1)	12.8 (5.4 to 20.2)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.015 ^[16]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

8.8

Confidence interval

level

95%

sides

2-sided

lower limit

2.8

upper limit

14.9

Notes
[16] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[17]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

22.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

30.3

Notes
[17] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0004 ^[18]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

10.9

upper limit

Notes
[18] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[19]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

44.3

Confidence interval

level

95%

sides

2-sided

lower limit

34.8

upper limit

53.8

Notes
[19] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[20]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

30.4

Confidence interval

level

95%

sides

2-sided

lower limit

19.7

upper limit

41.2

Notes
[20] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[21]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

47.4

Confidence interval

level

95%

sides

2-sided

lower limit

36.8

upper limit

Notes
[21] - P-value was adjusted by randomization strata (baseline disease severity and age category).

Secondary: Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 points Improvement From Baseline at Weeks 2, 4 and 8

Top of page

End point title

Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 points Improvement From Baseline at Weeks 2, 4 and 8

End point description

IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), 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; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n=157, 152, 76)	5.1 (1.7 to 8.5)	14.5 (8.9 to 20.1)	0 (0.0 to 4.7)
Week 4 (n=155, 153, 77)	14.2 (8.7 to 19.7)	33.3 (25.9 to 40.8)	1.3 (0.0 to 3.8)
Week 8 (n=157, 154, 78)	22.3 (15.8 to 28.8)	37.7 (30.0 to 45.3)	10.3 (3.5 to 17.0)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0459 ^[22]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

5.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

Notes
[22] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0005 ^[23]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

14.2

Confidence interval

level

95%

sides

2-sided

lower limit

7.8

upper limit

20.5

Notes
[23] - P-value was adjusted by randomization strata (baseline disease severity and age category)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0019 ^[24]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

12.9

Confidence interval

level

95%

sides

2-sided

lower limit

6.3

upper limit

19.4

Notes
[24] - P-value was adjusted by randomization strata (baseline disease severity and age category)

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[25]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

31.8

Confidence interval

level

95%

sides

2-sided

lower limit

23.6

upper limit

39.9

Notes
[25] - P-value was adjusted by randomization strata (baseline disease severity and age category)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0246 ^[26]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

11.9

Confidence interval

level

95%

sides

2-sided

lower limit

2.4

upper limit

21.4

Notes
[26] - P-value was adjusted by randomization strata (baseline disease severity and age category)

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[27]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

26.9

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

36.9

Notes
[27] - P-value was adjusted by randomization strata (baseline disease severity and age category)

Secondary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12

Top of page

End point title

Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12

End point description

IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 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, induration lichenification, excoriation, and no oozing; 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; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n=157, 152, 76)	0 (0.0 to 2.3)	2.0 (0.0 to 4.2)	0 (0.0 to 4.7)
Week 4 (n=155, 153, 77)	1.9 (0.0 to 4.1)	4.6 (1.3 to 7.9)	0 (0.0 to 4.7)
Week 8 (n=157, 154, 78)	1.3 (0.0 to 3.0)	4.5 (1.3 to 7.8)	0 (0.0 to 4.6)
Week 12 (n=155, 155, 77)	5.2 (1.7 to 8.6)	6.5 (2.6 to 10.3)	0 (0.0 to 4.7)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

3.7

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2262 ^[28]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

6.1

Notes
[28] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2223 ^[29]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

6.1

Notes
[29] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0597 ^[30]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

4.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

9.2

Notes
[30] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3207 ^[31]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

5.2

Notes
[31] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0586 ^[32]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

4.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

9.2

Notes
[32] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0419 ^[33]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

5.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

10.1

Notes
[33] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0244 ^[34]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

6.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.2

upper limit

11.4

Notes
[34] - P-value was adjusted by randomization strata (baseline disease severity and age category).

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12

Top of page

End point title

Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12

End point description

EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in 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. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n=157, 152, 76)	35.7 (28.2 to 43.2)	55.3 (47.4 to 63.2)	10.5 (3.6 to 17.4)
Week 4 (n=155, 153, 77)	58.7 (51.0 to 66.5)	78.4 (71.9 to 84.9)	28.6 (18.5 to 38.7)
Week 8 (n=157, 154, 78)	66.2 (58.8 to 73.6)	82.5 (76.5 to 88.5)	34.6 (24.1 to 45.2)
Week 12 (n=155, 154, 77)	68.4 (61.1 to 75.7)	79.9 (73.5 to 86.2)	19.5 (10.6 to 28.3)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[35]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

14.8

upper limit

35.2

Notes
[35] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[36]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

44.2

Confidence interval

level

95%

sides

2-sided

lower limit

33.9

upper limit

54.6

Notes
[36] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[37]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

30.2

Confidence interval

level

95%

sides

2-sided

lower limit

17.5

upper limit

42.8

Notes
[37] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[38]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

49.8

Confidence interval

level

95%

sides

2-sided

lower limit

37.8

upper limit

61.7

Notes
[38] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[39]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

31.5

Confidence interval

level

95%

sides

2-sided

lower limit

18.8

upper limit

44.3

Notes
[39] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[40]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

47.6

Confidence interval

level

95%

sides

2-sided

lower limit

35.7

upper limit

59.6

Notes
[40] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[41]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

48.7

Confidence interval

level

95%

sides

2-sided

lower limit

37.2

upper limit

60.1

Notes
[41] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[42]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

60.1

Confidence interval

level

95%

sides

2-sided

lower limit

49.1

upper limit

Notes
[42] - P-value was adjusted by randomization strata (baseline disease severity and age category).

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12

Top of page

End point title

Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12

End point description

EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in 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. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n= 157, 152, 76)	2.5 (0.1 to 5.0)	9.2 (4.6 to 13.8)	0 (0.0 to 4.7)
Week 4 (n= 155, 153, 77)	9.7 (5.0 to 14.3)	22.9 (16.2 to 29.5)	0 (0.0 to 4.7)
Week 8 (n= 157, 154, 78)	17.2 (11.3 to 23.1)	34.4 (26.9 to 41.9)	2.6 (0.0 to 6.1)
Week 12 (n= 155, 154, 77)	23.9 (17.2 to 30.6)	37.7 (30.0 to 45.3)	3.9 (0.0 to 8.2)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1623 ^[43]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

6.8

Notes
[43] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[44]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

9.1

Confidence interval

level

95%

sides

2-sided

lower limit

3.4

upper limit

14.7

Notes
[44] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0049 ^[45]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

9.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

15.4

Notes
[45] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[46]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

22.9

Confidence interval

level

95%

sides

2-sided

lower limit

15.5

upper limit

30.2

Notes
[46] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0013 ^[47]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

14.6

Confidence interval

level

95%

sides

2-sided

lower limit

7.2

upper limit

Notes
[47] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[48]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

31.6

Confidence interval

level

95%

sides

2-sided

lower limit

23.1

upper limit

40.1

Notes
[48] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0001 ^[49]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

20.1

Confidence interval

level

95%

sides

2-sided

lower limit

11.9

upper limit

28.3

Notes
[49] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

33.5

Confidence interval

level

95%

sides

2-sided

lower limit

24.6

upper limit

42.5

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12

Top of page

End point title

Percentage of Subjects Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12

End point description

EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in 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. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n= 157, 152, 76)	0 (0.0 to 2.3)	1.3 (0.0 to 3.1)	0 (0.0 to 4.7)
Week 4 (n= 155, 153, 77)	1.3 (0.0 to 3.1)	3.9 (0.8 to 7.0)	0 (0.0 to 4.7)
Week 8 (n= 157, 154, 78)	1.3 (0.0 to 3.0)	3.9 (0.8 to 7.0)	0 (0.0 to 4.6)
Week 12 (n= 155, 154, 77)	5.2 (1.7 to 8.6)	7.1 (3.1 to 11.2)	0 (0.0 to 4.7)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0 ^[50]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

3.7

Notes
[50] - P-value could not be calculated since percentage of subjects with events was 0.

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3261 ^[51]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.8

upper limit

5.3

Notes
[51] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3207 ^[52]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

5.3

Notes
[52] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.081 ^[53]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

3.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

8.5

Notes
[53] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3207 ^[54]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

5.2

Notes
[54] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.081 ^[55]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

3.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

8.4

Notes
[55] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0419 ^[56]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

5.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

10.1

Notes
[56] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.018 ^[57]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

12.2

Notes
[57] - P-value was adjusted by randomization strata (baseline disease severity and age category).

Secondary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12

Top of page

End point title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percent change
least squares mean (confidence interval 95%)
Change at Week 2	-39.2 (-43.8 to -34.7)	-51.3 (-55.9 to -46.7)	-9.0 (-15.4 to -2.5)
Change at Week 4	-54.3 (-59.1 to -49.5)	-69.0 (-73.7 to -64.2)	-24.4 (-31.1 to -17.7)
Change at Week 8	-59.5 (-65.0 to -54.0)	-73.2 (-78.7 to -67.7)	-33.0 (-41.1 to -25.0)
Change at Week 12	-60.0 (-66.5 to -53.6)	-73.3 (-79.7 to -66.9)	-28.6 (-38.4 to -18.8)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-30.2

Confidence interval

level

95%

sides

2-sided

lower limit

-38.1

upper limit

-22.3

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-42.3

Confidence interval

level

95%

sides

2-sided

lower limit

-50.3

upper limit

-34.4

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-29.9

Confidence interval

level

95%

sides

2-sided

lower limit

-38.1

upper limit

-21.7

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-44.6

Confidence interval

level

95%

sides

2-sided

lower limit

-52.8

upper limit

-36.3

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-26.4

Confidence interval

level

95%

sides

2-sided

lower limit

-36.2

upper limit

-16.7

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-40.2

Confidence interval

level

95%

sides

2-sided

lower limit

-50

upper limit

-30.4

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-31.4

Confidence interval

level

95%

sides

2-sided

lower limit

-43.1

upper limit

-19.7

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-44.7

Confidence interval

level

95%

sides

2-sided

lower limit

-56.4

upper limit

-33

Secondary: Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12

Top of page

End point title

Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12

End point description

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 by handprint method. Number of handprints 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 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 calculated: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, higher values = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: Percentage of BSA
least squares mean (confidence interval 95%)
Week 2	-27.8 (-33.0 to -22.6)	-35.4 (-40.6 to -30.2)	-1.3 (-8.7 to 6.0)
Week 4	-45.0 (-50.4 to -39.6)	-55.7 (-61.1 to -50.3)	-15.3 (-22.9 to -7.7)
Week 8	-53.4 (-60.0 to -46.8)	-61.1 (-67.7 to -54.5)	-20.5 (-30.1 to -10.9)
Week 12	-56.4 (-63.1 to -49.6)	-65.0 (-71.7 to -58.3)	-16.8 (-26.9 to -6.6)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-26.5

Confidence interval

level

95%

sides

2-sided

lower limit

-35.5

upper limit

-17.5

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-34.1

Confidence interval

level

95%

sides

2-sided

lower limit

-43.1

upper limit

-25.1

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-29.7

Confidence interval

level

95%

sides

2-sided

lower limit

-39

upper limit

-20.4

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-40.5

Confidence interval

level

95%

sides

2-sided

lower limit

-49.8

upper limit

-31.1

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-32.9

Confidence interval

level

95%

sides

2-sided

lower limit

-44.6

upper limit

-21.2

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-40.6

Confidence interval

level

95%

sides

2-sided

lower limit

-52.2

upper limit

-28.9

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-39.6

Confidence interval

level

95%

sides

2-sided

lower limit

-51.8

upper limit

-27.4

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-48.2

Confidence interval

level

95%

sides

2-sided

lower limit

-60.4

upper limit

-36

Secondary: Percentage of Subjects With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12

Top of page

End point title

Percentage of Subjects With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12

End point description

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 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. SA of body region: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % 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, ranges from 0 to 100%, with higher values = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. “n” = the number of subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n=157, 152, 76)	1.9 (0.0 to 4.1)	5.9 (2.2 to 9.7)	0 (0.0 to 4.7)
Week 4 (n=155, 153, 77)	6.5 (2.6 to 10.3)	17.0 (11.0 to 22.9)	0 (0.0 to 4.7)
Week 8 (n=157, 154, 78)	15.9 (10.2 to 21.6)	27.3 (20.2 to 34.3)	1.3 (0.0 to 3.8)
Week 12 (n=155, 154, 77)	22.6 (16.0 to 29.2)	34.4 (26.9 to 41.9)	3.9 (0.0 to 8.2)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2353 ^[58]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

Notes
[58] - P-value was adjusted by randomization strata (baseline disease severity and age category)

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0332 ^[59]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

5.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

10.8

Notes
[59] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0227 ^[60]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

6.5

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

11.6

Notes
[60] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0001 ^[61]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

16.8

Confidence interval

level

95%

sides

2-sided

lower limit

10.1

upper limit

23.5

Notes
[61] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0008 ^[62]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

14.5

Confidence interval

level

95%

sides

2-sided

lower limit

7.7

upper limit

21.3

Notes
[62] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[63]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

25.8

Confidence interval

level

95%

sides

2-sided

lower limit

18.1

upper limit

33.4

Notes
[63] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0003 ^[64]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

18.5

Confidence interval

level

95%

sides

2-sided

lower limit

10.5

upper limit

26.5

Notes
[64] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

30.2

Confidence interval

level

95%

sides

2-sided

lower limit

21.4

upper limit

Secondary: Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12

Top of page

End point title

Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12

End point description

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA - head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis set population included. Number Analyzed = number of subjects evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n= 157, 152, 76)	12.7 (7.5 to 18.0)	32.9 (25.4 to 40.4)	0 (0.0 to 4.7)
Week 4 (n= 155, 153, 77)	36.1 (28.6 to 43.7)	60.8 (53.0 to 68.5)	7.8 (1.8 to 13.8)
Week 8 (n= 157, 154, 78)	43.3 (35.6 to 51.1)	61.7 (54.0 to 69.4)	15.4 (7.4 to 23.4)
Week 12 (n= 155, 155, 76)	49.0 (41.2 to 56.9)	62.6 (55.0 to 70.2)	12.8 (5.4 to 20.2)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0011 ^[65]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

12.7

Confidence interval

level

95%

sides

2-sided

lower limit

6.5

upper limit

18.9

Notes
[65] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[66]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

32.6

Confidence interval

level

95%

sides

2-sided

lower limit

24.6

upper limit

40.6

Notes
[66] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[67]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

28.3

Confidence interval

level

95%

sides

2-sided

lower limit

18.5

upper limit

38.2

Notes
[67] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[68]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

52.8

Confidence interval

level

95%

sides

2-sided

lower limit

43.2

upper limit

62.5

Notes
[68] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[69]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Notes
[69] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[70]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

46.1

Confidence interval

level

95%

sides

2-sided

lower limit

35.2

upper limit

57.1

Notes
[70] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[71]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

36.2

Confidence interval

level

95%

sides

2-sided

lower limit

25.4

upper limit

47.1

Notes
[71] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[72]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

49.6

Confidence interval

level

95%

sides

2-sided

lower limit

38.9

upper limit

60.3

Notes
[72] - P-value was adjusted by randomization strata (baseline disease severity and age category).

Secondary: Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12

Top of page

End point title

Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percentage of subjects
number (confidence interval 95%)
Week 2 (n= 157, 152, 76)	1.9 (0.0 to 4.1)	5.3 (1.7 to 8.8)	0 (0.0 to 4.7)
Week 4 (n= 155, 153, 77)	7.1 (3.1 to 11.1)	17.6 (11.6 to 23.7)	0 (0.0 to 4.7)
Week 8 (n= 157, 154, 78)	11.5 (6.5 to 16.4)	26.0 (19.0 to 32.9)	0 (0.0 to 4.6)
Week 12 (n= 155, 155, 78)	18.7 (12.6 to 24.8)	30.3 (23.1 to 37.6)	2.6 (0.0 to 6.1)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2261 ^[73]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

Notes
[73] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0451 ^[74]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

5.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

Notes
[74] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0171 ^[75]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

12.3

Notes
[75] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[76]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

17.7

Confidence interval

level

95%

sides

2-sided

lower limit

10.9

upper limit

24.5

Notes
[76] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0018 ^[77]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

11.5

Confidence interval

level

95%

sides

2-sided

lower limit

5.5

upper limit

17.5

Notes
[77] - P-value was adjusted by randomization strata (baseline disease severity and age category)

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[78]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

25.7

Confidence interval

level

95%

sides

2-sided

lower limit

18.3

upper limit

33.1

Notes
[78] - P-value was adjusted by randomization strata (baseline disease severity and age category)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0005 ^[79]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

16.2

Confidence interval

level

95%

sides

2-sided

lower limit

8.8

upper limit

23.6

Notes
[79] - P-value was adjusted by randomization strata (baseline disease severity and age category).

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[80]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

27.6

Confidence interval

level

95%

sides

2-sided

lower limit

19.3

upper limit

35.8

Notes
[80] - P-value was adjusted by randomization strata (baseline disease severity and age category).

Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12

Top of page

End point title

Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12

End point description

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA - head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0-100). Severity (B): severity sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2, severe=3. The severity scores summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, these 2 were scored by subject using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness summed to give 'C' (0-20). The SCORAD was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. This endpoint was not analyzed as planned because the severity assessment of itch was measured more effectively in other endpoints, such as the numerical rating scale.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	0 ^[81]	0 ^[82]	0 ^[83]
Units: units on a scale

Notes
[81] - Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS.
[82] - Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS.
[83] - Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS.

No statistical analyses for this end point

Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12

Top of page

End point title

Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12

End point description

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA - head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis population set included. Number Analyzed = number of subjects evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: units on a scale
least squares mean (confidence interval 95%)
Change at Week 2 (n= 155, 151, 76)	-1.9 (-2.2 to -1.5)	-2.9 (-3.3 to -2.5)	-0.5 (-1.0 to 0.0)
Change at Week 4 (n= 149, 151, 76)	-2.8 (-3.1 to -2.4)	-3.9 (-4.3 to -3.6)	-1.0 (-1.5 to -0.5)
Change at Week 8 (n= 148, 149, 66)	-3.1 (-3.5 to -2.7)	-3.9 (-4.3 to -3.5)	-1.5 (-2.1 to -0.9)
Change at Week 12 (n= 140, 146, 56)	-3.0 (-3.4 to -2.6)	-3.8 (-4.2 to -3.4)	-2.1 (-2.7 to -1.5)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

-0.8

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-2.4

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1.8

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix.

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

-1.2

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

-2.3

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

-0.9

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-2.4

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

-1.7

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0164

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

-0.2

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

-1

Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12

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End point title

Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 8, and 12

End point values	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Number of subjects analysed	158	155	78
Units: percent change
least squares mean (confidence interval 95%)
Change at Week 2	-27.2 (-30.5 to -23.9)	-38.5 (-41.8 to -35.1)	-6.3 (-11.0 to -1.6)
Change at Week 4	-38.9 (-42.6 to -35.1)	-53.1 (-56.9 to -49.4)	-17.2 (-22.5 to -12.0)
Change at Week 8	-42.6 (-46.7 to -38.4)	-56.7 (-60.9 to -52.6)	-23.1 (-29.2 to -17.1)
Change at Week 12	-45.8 (-50.9 to -40.7)	-56.2 (-61.2 to -51.1)	-22.7 (-30.4 to -15.1)

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-20.9

Confidence interval

level

95%

sides

2-sided

lower limit

-26.6

upper limit

-15.1

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-32.1

Confidence interval

level

95%

sides

2-sided

lower limit

-37.9

upper limit

-26.4

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-21.6

Confidence interval

level

95%

sides

2-sided

lower limit

-28.1

upper limit

-15.2

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-35.9

Confidence interval

level

95%

sides

2-sided

lower limit

-42.3

upper limit

-29.4

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-19.4

Confidence interval

level

95%

sides

2-sided

lower limit

-26.8

upper limit

-12.1

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-33.6

Confidence interval

level

95%

sides

2-sided

lower limit

-41

upper limit

-26.3

PF-04965842 100 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 100 mg v Placebo

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-23.1

Confidence interval

level

95%

sides

2-sided

lower limit

-32.3

upper limit

-13.9

PF-04965842 200 mg Versus Placebo

Statistical analysis description

Comparison groups

PF-04965842 200 mg v Placebo

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Difference in LS mean

Point estimate

-33.4

Confidence interval

level

95%

sides

2-sided

lower limit

-42.6

upper limit

-24.3

Adverse events

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Timeframe for reporting adverse events

Baseline up to Week 16

Adverse event reporting additional description

Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as nonserious in another subject or 1 subject may have experienced both serious and nonserious event during study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

22.0

Reporting group title

PF-04965842 100 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

PF-04965842 200 mg

Reporting group description

Serious adverse events	PF-04965842 100 mg	Placebo	PF-04965842 200 mg
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 158 (3.16%)	1 / 78 (1.28%)	2 / 155 (1.29%)
number of deaths (all causes)	1	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Femoral neck fracture
subjects affected / exposed	0 / 158 (0.00%)	0 / 78 (0.00%)	1 / 155 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Sudden death
subjects affected / exposed	1 / 158 (0.63%)	0 / 78 (0.00%)	0 / 155 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic shock
subjects affected / exposed	0 / 158 (0.00%)	0 / 78 (0.00%)	1 / 155 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	1 / 158 (0.63%)	0 / 78 (0.00%)	0 / 155 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Eczema herpeticum
subjects affected / exposed	0 / 158 (0.00%)	1 / 78 (1.28%)	0 / 155 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpangina
subjects affected / exposed	1 / 158 (0.63%)	0 / 78 (0.00%)	0 / 155 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteomyelitis bacterial
subjects affected / exposed	1 / 158 (0.63%)	0 / 78 (0.00%)	0 / 155 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 158 (0.63%)	0 / 78 (0.00%)	0 / 155 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	1 / 158 (0.63%)	0 / 78 (0.00%)	0 / 155 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal skin infection
subjects affected / exposed	0 / 158 (0.00%)	1 / 78 (1.28%)	0 / 155 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	PF-04965842 100 mg	Placebo	PF-04965842 200 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	56 / 158 (35.44%)	22 / 78 (28.21%)	52 / 155 (33.55%)
Nervous system disorders
Headache
subjects affected / exposed	9 / 158 (5.70%)	2 / 78 (2.56%)	12 / 155 (7.74%)
occurrences all number	10	4	16
Gastrointestinal disorders
Nausea
subjects affected / exposed	12 / 158 (7.59%)	2 / 78 (2.56%)	22 / 155 (14.19%)
occurrences all number	13	2	28
Vomiting
subjects affected / exposed	2 / 158 (1.27%)	1 / 78 (1.28%)	8 / 155 (5.16%)
occurrences all number	2	1	9
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	2 / 158 (1.27%)	0 / 78 (0.00%)	9 / 155 (5.81%)
occurrences all number	2	0	9
Dermatitis atopic
subjects affected / exposed	9 / 158 (5.70%)	12 / 78 (15.38%)	6 / 155 (3.87%)
occurrences all number	9	13	7
Infections and infestations
Nasopharyngitis
subjects affected / exposed	20 / 158 (12.66%)	5 / 78 (6.41%)	12 / 155 (7.74%)
occurrences all number	20	5	12
Upper respiratory tract infection
subjects affected / exposed	14 / 158 (8.86%)	3 / 78 (3.85%)	5 / 155 (3.23%)
occurrences all number	16	4	6

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of PF-04965842 Monotherapy in Subjects Aged 12 Years and Older, With Moderate to Severe Atopic Dermatitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

Primary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

Primary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12

Primary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12

Secondary: Percentage of Subjects who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12

Secondary: Percentage of Subjects who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12

Secondary: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12

Secondary: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12

Secondary: Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus

Secondary: Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8

Secondary: Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 points Improvement From Baseline at Weeks 2, 4 and 8

Secondary: Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 points Improvement From Baseline at Weeks 2, 4 and 8

Secondary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12

Secondary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12

Secondary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12

Secondary: Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12

Secondary: Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12

Secondary: Percentage of Subjects With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12

Secondary: Percentage of Subjects With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12

Secondary: Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12

Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12

Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12

Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12

Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12

Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12

Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of PF-04965842 Monotherapy in Subjects Aged 12 Years and Older, With Moderate to Severe Atopic Dermatitis