Atopic Dermatitis
Conditions
Keywords
Phase 2, randomized, double-blind, placebo, atopic dermatitis, safety, efficacy, JAK, janus kinase, moderate, severe
Brief summary
Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.
Interventions
DRUGPF-04965842
10 mg of PF-04965842 QD for 12 weeks
DRUGPlacebo
Placebo QD for 12 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects between 18 75 years of age, inclusive, at time of informed consent. * Must have the following atopic dermatitis criteria: 1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit. 2. Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug. 3. Moderate to severe AD (affected BSA \>=10 %, IGA \>=3, and EASI \>=12 at the screening and baseline visits).
Exclusion criteria
* History of human immunodeficiency virus (HIV) or positive HIV serology at screening, * Infected with hepatitis B or hepatitis C viruses. * Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) * Have received any of the following treatment regiments specified in the timeframes outlined below: Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine. Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor. Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 | Baseline and Week 12 | The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16. | The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). |
| Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). |
| Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16 | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. |
| Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10). |
| Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10). |
| Time to Achieving >=3 Points Improvement in NRS | Baseline till Week 16 | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10). |
| Time to Achieving >=4 Points Improvement in NRS | Baseline till Week 16 | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10). |
| Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10). |
| Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10). |
| Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. |
| Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. |
| Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 | Baseline and Week 12 | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. |
| Change From Baseline in Affected BSA at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%. |
| Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. |
| Percent Change From Baseline in SCORAD at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. |
| Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. |
| Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. |
| Number of Participants With Treatment-emergent Adverse Events (AEs) | Baseline till Week 16 | An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | Baseline up to Week 16 | — |
| Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, severe (4), moderate (3), mild (2),almost clear (1), and clear (0). The PtGA was completed as per schedule of activities. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 | The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as very much (3), a lot (2), a little (1) and not at all (0). The score can range from 0 to 30. The higher values represent the worse dermatology life quality. |
| Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 | The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28. The higher values represent more severe AD. |
| Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 | The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. |
| Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. |
Countries
Australia, Canada, Germany, Hungary, United States
Participant flow
Pre-assignment details
A total of 269 participants were randomized. There were 2 participants who were randomized but did not receive any study treatment. All other participants were treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo tablets for a 12-week double-blind treatment period. | 56 |
| PF-04965842 10mg QD Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. | 49 |
| PF-04965842 30mg QD Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. | 51 |
| PF-04965842 100mg QD Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. | 56 |
| PF-04965842 200mg QD Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. | 55 |
| Total | 267 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 8 | 8 | 12 | 8 |
| Overall Study | Does not meet entrance criteria | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 6 | 5 | 6 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 | 0 | 0 |
| Overall Study | No longer meets eligibility criteria | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Other | 0 | 0 | 3 | 1 | 2 |
| Overall Study | Protocol Violation | 5 | 5 | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 4 | 4 | 3 | 4 |
Baseline characteristics
| Characteristic | Placebo | PF-04965842 10mg QD | PF-04965842 30mg QD | PF-04965842 100mg QD | PF-04965842 200mg QD | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 15.1 | 44.3 years STANDARD_DEVIATION 15.9 | 37.6 years STANDARD_DEVIATION 15.9 | 41.1 years STANDARD_DEVIATION 15.6 | 38.7 years STANDARD_DEVIATION 17.6 | 40.8 years STANDARD_DEVIATION 16.1 |
| Race/Ethnicity, Customized Asian | 4 Participants | 5 Participants | 5 Participants | 8 Participants | 5 Participants | 27 Participants |
| Race/Ethnicity, Customized Black | 10 Participants | 5 Participants | 4 Participants | 7 Participants | 13 Participants | 39 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 38 Participants | 39 Participants | 40 Participants | 37 Participants | 194 Participants |
| Sex: Female, Male Female | 35 Participants | 28 Participants | 29 Participants | 25 Participants | 27 Participants | 144 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 22 Participants | 31 Participants | 28 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 49 | 0 / 51 | 0 / 56 | 0 / 55 |
| other Total, other adverse events | 17 / 56 | 18 / 49 | 25 / 51 | 25 / 56 | 27 / 55 |
| serious Total, serious adverse events | 2 / 56 | 2 / 49 | 0 / 51 | 3 / 56 | 2 / 55 |
Outcome results
Primary
Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12
The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time frame: Baseline and Week 12
Population: Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 | 6.3 percentage of participants | Standard Error 2.55 |
| PF-04965842 10mg QD | Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 | 8.2 percentage of participants | Standard Error 2.32 |
| PF-04965842 30mg QD | Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 | 12.3 percentage of participants | Standard Error 2.88 |
| PF-04965842 100mg QD | Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 | 27.8 percentage of participants | Standard Error 5.07 |
| PF-04965842 200mg QD | Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 | 44.5 percentage of participants | Standard Error 6.92 |
p-value: 0.12195% CI: [-0.7, 4.4]Emax model
p-value: 0.106595% CI: [-1.8, 13.8]Emax model
p-value: 0.018495% CI: [5.5, 37.6]Emax model
p-value: 0.003295% CI: [19.7, 56.6]Emax model
Secondary
Change From Baseline in Affected BSA at All Scheduled Time Points
BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 16 | -8.09 percentage of BSA | Standard Deviation 15.797 |
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 8 | -9.71 percentage of BSA | Standard Deviation 17.837 |
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 2 | -5.43 percentage of BSA | Standard Deviation 10.03 |
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 12 | -13.82 percentage of BSA | Standard Deviation 22.348 |
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 14 | -8.97 percentage of BSA | Standard Deviation 16.223 |
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 4 | -6.34 percentage of BSA | Standard Deviation 16.138 |
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 13 | -7.90 percentage of BSA | Standard Deviation 18.233 |
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 6 | -10.79 percentage of BSA | Standard Deviation 16.413 |
| Placebo | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 1 | -0.06 percentage of BSA | Standard Deviation 6.699 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 13 | -11.07 percentage of BSA | Standard Deviation 25.457 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 12 | -11.59 percentage of BSA | Standard Deviation 27.112 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 6 | -11.80 percentage of BSA | Standard Deviation 22.324 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 8 | -12.98 percentage of BSA | Standard Deviation 25.552 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 4 | -8.93 percentage of BSA | Standard Deviation 15.96 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 16 | -14.64 percentage of BSA | Standard Deviation 20.948 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 2 | -4.84 percentage of BSA | Standard Deviation 16.179 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 1 | -3.76 percentage of BSA | Standard Deviation 13.94 |
| PF-04965842 10mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 14 | -10.46 percentage of BSA | Standard Deviation 26.13 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 12 | -9.37 percentage of BSA | Standard Deviation 18.783 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 1 | -2.45 percentage of BSA | Standard Deviation 7.017 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 2 | -6.51 percentage of BSA | Standard Deviation 10.485 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 4 | -9.59 percentage of BSA | Standard Deviation 14.845 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 6 | -10.71 percentage of BSA | Standard Deviation 15.007 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 8 | -10.79 percentage of BSA | Standard Deviation 19.259 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 13 | -7.79 percentage of BSA | Standard Deviation 17.469 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 14 | -6.33 percentage of BSA | Standard Deviation 17.404 |
| PF-04965842 30mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 16 | -3.52 percentage of BSA | Standard Deviation 20.967 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 6 | -18.80 percentage of BSA | Standard Deviation 23.387 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 12 | -22.21 percentage of BSA | Standard Deviation 22.199 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 4 | -17.77 percentage of BSA | Standard Deviation 19.956 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 13 | -17.88 percentage of BSA | Standard Deviation 20.905 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 2 | -10.80 percentage of BSA | Standard Deviation 16.432 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 16 | -5.55 percentage of BSA | Standard Deviation 21.079 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 14 | -12.75 percentage of BSA | Standard Deviation 22.492 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 1 | -4.63 percentage of BSA | Standard Deviation 12.144 |
| PF-04965842 100mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 8 | -19.41 percentage of BSA | Standard Deviation 23.596 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 1 | -10.86 percentage of BSA | Standard Deviation 15.69 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 6 | -30.51 percentage of BSA | Standard Deviation 20.853 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 12 | -27.72 percentage of BSA | Standard Deviation 18.361 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 4 | -28.55 percentage of BSA | Standard Deviation 20.447 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 8 | -29.98 percentage of BSA | Standard Deviation 20.864 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 16 | -17.88 percentage of BSA | Standard Deviation 17.059 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 14 | -16.35 percentage of BSA | Standard Deviation 18.931 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 13 | -22.61 percentage of BSA | Standard Deviation 22.39 |
| PF-04965842 200mg QD | Change From Baseline in Affected BSA at All Scheduled Time Points | Week 2 | -21.30 percentage of BSA | Standard Deviation 19.285 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as very much (3), a lot (2), a little (1) and not at all (0). The score can range from 0 to 30. The higher values represent the worse dermatology life quality.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 1 | -1.4 units on a scale | Standard Deviation 6.04 |
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 2 | -2.3 units on a scale | Standard Deviation 5.42 |
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 4 | -2.6 units on a scale | Standard Deviation 6.77 |
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 6 | -4.2 units on a scale | Standard Deviation 6.01 |
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 8 | -3.7 units on a scale | Standard Deviation 7.67 |
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 12 | -4.6 units on a scale | Standard Deviation 8.49 |
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 14 | -3.1 units on a scale | Standard Deviation 8.24 |
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 16 | -4.5 units on a scale | Standard Deviation 7.95 |
| PF-04965842 10mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 4 | -3.7 units on a scale | Standard Deviation 7.33 |
| PF-04965842 10mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 12 | -4.5 units on a scale | Standard Deviation 8.9 |
| PF-04965842 10mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 1 | -1.4 units on a scale | Standard Deviation 5.66 |
| PF-04965842 10mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 6 | -4.6 units on a scale | Standard Deviation 7.3 |
| PF-04965842 10mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 2 | -1.9 units on a scale | Standard Deviation 6.58 |
| PF-04965842 10mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 16 | -4.5 units on a scale | Standard Deviation 7.14 |
| PF-04965842 10mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 8 | -5.6 units on a scale | Standard Deviation 8.44 |
| PF-04965842 10mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 14 | -3.9 units on a scale | Standard Deviation 7.62 |
| PF-04965842 30mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 14 | -3.6 units on a scale | Standard Deviation 6.6 |
| PF-04965842 30mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 16 | -3.5 units on a scale | Standard Deviation 7.17 |
| PF-04965842 30mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 6 | -4.1 units on a scale | Standard Deviation 7.75 |
| PF-04965842 30mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 12 | -5.2 units on a scale | Standard Deviation 7.3 |
| PF-04965842 30mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 4 | -4.7 units on a scale | Standard Deviation 5.62 |
| PF-04965842 30mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 2 | -5.0 units on a scale | Standard Deviation 5.55 |
| PF-04965842 30mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 1 | -3.4 units on a scale | Standard Deviation 6.28 |
| PF-04965842 30mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 8 | -4.8 units on a scale | Standard Deviation 8.52 |
| PF-04965842 100mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 2 | -7.5 units on a scale | Standard Deviation 6.39 |
| PF-04965842 100mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 4 | -8.2 units on a scale | Standard Deviation 7.48 |
| PF-04965842 100mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 6 | -9.1 units on a scale | Standard Deviation 6.75 |
| PF-04965842 100mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 8 | -9.2 units on a scale | Standard Deviation 7.95 |
| PF-04965842 100mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 12 | -9.8 units on a scale | Standard Deviation 8.18 |
| PF-04965842 100mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 16 | -4.6 units on a scale | Standard Deviation 7.62 |
| PF-04965842 100mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 1 | -5.1 units on a scale | Standard Deviation 5.4 |
| PF-04965842 100mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 14 | -6.2 units on a scale | Standard Deviation 7.87 |
| PF-04965842 200mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 6 | -10.2 units on a scale | Standard Deviation 6.72 |
| PF-04965842 200mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 16 | -3.6 units on a scale | Standard Deviation 7.39 |
| PF-04965842 200mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 4 | -9.7 units on a scale | Standard Deviation 6.82 |
| PF-04965842 200mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 14 | -4.4 units on a scale | Standard Deviation 8.78 |
| PF-04965842 200mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 1 | -6.3 units on a scale | Standard Deviation 5.55 |
| PF-04965842 200mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 12 | -9.5 units on a scale | Standard Deviation 7.28 |
| PF-04965842 200mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 2 | -8.6 units on a scale | Standard Deviation 6.46 |
| PF-04965842 200mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | Week 8 | -9.8 units on a scale | Standard Deviation 7.1 |
Secondary
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28. The higher values represent more severe AD.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 1 | -1.1 units on a scale | Standard Deviation 3.59 |
| Placebo | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 14 | -2.2 units on a scale | Standard Deviation 6.45 |
| Placebo | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 4 | -2.2 units on a scale | Standard Deviation 6.05 |
| Placebo | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 16 | -3.0 units on a scale | Standard Deviation 7.76 |
| Placebo | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 2 | -2.2 units on a scale | Standard Deviation 4.2 |
| Placebo | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 8 | -2.3 units on a scale | Standard Deviation 5.91 |
| Placebo | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 12 | -3.8 units on a scale | Standard Deviation 8.21 |
| Placebo | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 6 | -3.5 units on a scale | Standard Deviation 5.24 |
| PF-04965842 10mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 14 | -3.9 units on a scale | Standard Deviation 8.04 |
| PF-04965842 10mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 8 | -4.3 units on a scale | Standard Deviation 8.94 |
| PF-04965842 10mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 16 | -3.0 units on a scale | Standard Deviation 7.67 |
| PF-04965842 10mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 2 | -1.9 units on a scale | Standard Deviation 6.13 |
| PF-04965842 10mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 6 | -4.3 units on a scale | Standard Deviation 7.63 |
| PF-04965842 10mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 4 | -3.6 units on a scale | Standard Deviation 6.35 |
| PF-04965842 10mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 1 | -0.6 units on a scale | Standard Deviation 4.17 |
| PF-04965842 10mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 12 | -4.7 units on a scale | Standard Deviation 8.83 |
| PF-04965842 30mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 2 | -4.1 units on a scale | Standard Deviation 6.04 |
| PF-04965842 30mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 1 | -2.1 units on a scale | Standard Deviation 5.83 |
| PF-04965842 30mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 4 | -4.3 units on a scale | Standard Deviation 5.69 |
| PF-04965842 30mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 6 | -3.9 units on a scale | Standard Deviation 7.43 |
| PF-04965842 30mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 8 | -5.4 units on a scale | Standard Deviation 8.05 |
| PF-04965842 30mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 12 | -5.3 units on a scale | Standard Deviation 7.6 |
| PF-04965842 30mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 14 | -2.7 units on a scale | Standard Deviation 6.05 |
| PF-04965842 30mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 16 | -2.2 units on a scale | Standard Deviation 6.8 |
| PF-04965842 100mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 8 | -10.6 units on a scale | Standard Deviation 8.47 |
| PF-04965842 100mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 4 | -8.7 units on a scale | Standard Deviation 8.3 |
| PF-04965842 100mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 12 | -11.4 units on a scale | Standard Deviation 8.08 |
| PF-04965842 100mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 2 | -7.2 units on a scale | Standard Deviation 6.79 |
| PF-04965842 100mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 16 | -4.3 units on a scale | Standard Deviation 6.2 |
| PF-04965842 100mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 14 | -6.3 units on a scale | Standard Deviation 7.12 |
| PF-04965842 100mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 6 | -10.4 units on a scale | Standard Deviation 8.17 |
| PF-04965842 100mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 1 | -3.9 units on a scale | Standard Deviation 4.67 |
| PF-04965842 200mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 6 | -15.0 units on a scale | Standard Deviation 5.92 |
| PF-04965842 200mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 4 | -14.6 units on a scale | Standard Deviation 6.2 |
| PF-04965842 200mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 8 | -15.2 units on a scale | Standard Deviation 6.15 |
| PF-04965842 200mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 16 | -5.9 units on a scale | Standard Deviation 5.93 |
| PF-04965842 200mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 14 | -6.2 units on a scale | Standard Deviation 6.97 |
| PF-04965842 200mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 12 | -15.1 units on a scale | Standard Deviation 6.99 |
| PF-04965842 200mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 2 | -11.9 units on a scale | Standard Deviation 5.95 |
| PF-04965842 200mg QD | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | Week 1 | -9.2 units on a scale | Standard Deviation 5.77 |
Secondary
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10).
Time frame: Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 12 | -0.92 units on a scale | Standard Deviation 1.988 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 3 | -0.22 units on a scale | Standard Deviation 1.418 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 4 | -0.22 units on a scale | Standard Deviation 1.389 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 5 | -0.32 units on a scale | Standard Deviation 1.406 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 6 | -0.28 units on a scale | Standard Deviation 1.727 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 7 | -0.53 units on a scale | Standard Deviation 2.023 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 8 | -0.30 units on a scale | Standard Deviation 2.215 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 9 | -0.38 units on a scale | Standard Deviation 2.08 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 10 | -0.43 units on a scale | Standard Deviation 1.947 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 11 | -0.73 units on a scale | Standard Deviation 1.955 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 2 | -0.08 units on a scale | Standard Deviation 1.307 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 13 | -1.21 units on a scale | Standard Deviation 1.989 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 14 | -1.11 units on a scale | Standard Deviation 2.003 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 15 | -1.39 units on a scale | Standard Deviation 2.034 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 29 | -1.63 units on a scale | Standard Deviation 2.453 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 43 | -1.93 units on a scale | Standard Deviation 2.325 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 57 | -1.84 units on a scale | Standard Deviation 2.594 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 85 | -2.26 units on a scale | Standard Deviation 3.081 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 99 | -1.57 units on a scale | Standard Deviation 3.025 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 113 | -2.43 units on a scale | Standard Deviation 3.259 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -0.06 units on a scale | Standard Deviation 1.754 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 3 | -0.38 units on a scale | Standard Deviation 1.894 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -0.20 units on a scale | Standard Deviation 1.738 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -0.42 units on a scale | Standard Deviation 1.727 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -0.40 units on a scale | Standard Deviation 2.25 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -0.63 units on a scale | Standard Deviation 2.181 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -0.42 units on a scale | Standard Deviation 2.205 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -0.54 units on a scale | Standard Deviation 2.24 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -0.80 units on a scale | Standard Deviation 2.198 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -0.96 units on a scale | Standard Deviation 2.336 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -1.06 units on a scale | Standard Deviation 2.322 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -1.33 units on a scale | Standard Deviation 2.337 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -1.17 units on a scale | Standard Deviation 2.417 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -1.50 units on a scale | Standard Deviation 2.322 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -1.46 units on a scale | Standard Deviation 2.518 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -1.70 units on a scale | Standard Deviation 1.99 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -1.74 units on a scale | Standard Deviation 2.298 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -2.23 units on a scale | Standard Deviation 3.209 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -1.30 units on a scale | Standard Deviation 2.781 |
| Placebo | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -2.00 units on a scale | Standard Deviation 2.97 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -2.51 units on a scale | Standard Deviation 3.061 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 57 | -1.97 units on a scale | Standard Deviation 3.398 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -0.64 units on a scale | Standard Deviation 2.2 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -0.40 units on a scale | Standard Deviation 1.679 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 11 | -0.61 units on a scale | Standard Deviation 2.148 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -0.55 units on a scale | Standard Deviation 1.606 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 85 | -2.13 units on a scale | Standard Deviation 3.711 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -0.68 units on a scale | Standard Deviation 2.38 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 12 | -0.73 units on a scale | Standard Deviation 2.245 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 4 | -0.09 units on a scale | Standard Deviation 1.117 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 15 | -0.69 units on a scale | Standard Deviation 1.937 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 99 | -1.48 units on a scale | Standard Deviation 2.992 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -0.43 units on a scale | Standard Deviation 1.676 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 10 | -0.61 units on a scale | Standard Deviation 1.967 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -0.91 units on a scale | Standard Deviation 2.133 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 7 | -0.52 units on a scale | Standard Deviation 1.745 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 113 | -1.38 units on a scale | Standard Deviation 3.201 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 14 | -0.78 units on a scale | Standard Deviation 2.104 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 8 | -0.56 units on a scale | Standard Deviation 1.56 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 3 | 0.02 units on a scale | Standard Deviation 1.357 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -1.42 units on a scale | Standard Deviation 3.035 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -0.44 units on a scale | Standard Deviation 1.198 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 29 | -1.34 units on a scale | Standard Deviation 2.383 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -1.34 units on a scale | Standard Deviation 2.425 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -1.10 units on a scale | Standard Deviation 2.417 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -2.00 units on a scale | Standard Deviation 3.499 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 3 | -0.16 units on a scale | Standard Deviation 1.461 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -0.75 units on a scale | Standard Deviation 2.036 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 13 | -0.68 units on a scale | Standard Deviation 1.801 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -1.56 units on a scale | Standard Deviation 2.736 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 6 | -0.55 units on a scale | Standard Deviation 1.405 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -0.32 units on a scale | Standard Deviation 1.073 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 9 | -0.75 units on a scale | Standard Deviation 1.844 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 43 | -2.24 units on a scale | Standard Deviation 2.929 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 2 | -0.20 units on a scale | Standard Deviation 1.217 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -0.66 units on a scale | Standard Deviation 2.411 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -0.43 units on a scale | Standard Deviation 1.516 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -2.33 units on a scale | Standard Deviation 3.575 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -0.97 units on a scale | Standard Deviation 2.135 |
| PF-04965842 10mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 5 | -0.27 units on a scale | Standard Deviation 1.264 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -0.93 units on a scale | Standard Deviation 2.526 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -1.40 units on a scale | Standard Deviation 2.402 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -2.22 units on a scale | Standard Deviation 2.761 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -1.04 units on a scale | Standard Deviation 2.557 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -1.53 units on a scale | Standard Deviation 2.466 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -1.74 units on a scale | Standard Deviation 2.542 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 14 | -2.10 units on a scale | Standard Deviation 2.211 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -2.00 units on a scale | Standard Deviation 2.182 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -2.61 units on a scale | Standard Deviation 2.692 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -1.74 units on a scale | Standard Deviation 2.567 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 7 | -1.51 units on a scale | Standard Deviation 2.422 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -1.84 units on a scale | Standard Deviation 2.76 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -1.79 units on a scale | Standard Deviation 2.541 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 15 | -2.06 units on a scale | Standard Deviation 2.508 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 11 | -1.72 units on a scale | Standard Deviation 2.462 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 6 | -1.47 units on a scale | Standard Deviation 2.492 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 29 | -2.17 units on a scale | Standard Deviation 2.519 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 10 | -2.09 units on a scale | Standard Deviation 2.698 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 5 | -1.55 units on a scale | Standard Deviation 2.348 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 43 | -2.50 units on a scale | Standard Deviation 2.562 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -2.17 units on a scale | Standard Deviation 2.407 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 57 | -2.55 units on a scale | Standard Deviation 2.943 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 8 | -1.65 units on a scale | Standard Deviation 2.514 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 4 | -1.09 units on a scale | Standard Deviation 2.263 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -2.28 units on a scale | Standard Deviation 2.953 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 85 | -2.68 units on a scale | Standard Deviation 2.749 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 12 | -2.28 units on a scale | Standard Deviation 2.271 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 99 | -1.37 units on a scale | Standard Deviation 2.452 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -2.00 units on a scale | Standard Deviation 2.225 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 3 | -0.85 units on a scale | Standard Deviation 2.095 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 113 | -1.32 units on a scale | Standard Deviation 2.41 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -0.94 units on a scale | Standard Deviation 1.737 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 3 | -0.79 units on a scale | Standard Deviation 2.331 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 2 | -0.83 units on a scale | Standard Deviation 1.672 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -2.45 units on a scale | Standard Deviation 2.943 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -1.02 units on a scale | Standard Deviation 2.162 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 13 | -1.98 units on a scale | Standard Deviation 2.268 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 9 | -1.95 units on a scale | Standard Deviation 2.527 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -1.49 units on a scale | Standard Deviation 2.349 |
| PF-04965842 30mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -1.90 units on a scale | Standard Deviation 2.195 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -4.09 units on a scale | Standard Deviation 3.663 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 10 | -2.21 units on a scale | Standard Deviation 2.412 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 11 | -2.33 units on a scale | Standard Deviation 2.415 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 12 | -2.46 units on a scale | Standard Deviation 2.578 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 13 | -2.84 units on a scale | Standard Deviation 2.164 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 14 | -2.53 units on a scale | Standard Deviation 2.567 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -3.77 units on a scale | Standard Deviation 3.317 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 15 | -2.79 units on a scale | Standard Deviation 2.29 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 29 | -3.58 units on a scale | Standard Deviation 3.322 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 43 | -3.77 units on a scale | Standard Deviation 3.778 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 57 | -4.00 units on a scale | Standard Deviation 3.336 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 85 | -4.21 units on a scale | Standard Deviation 3.529 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -4.02 units on a scale | Standard Deviation 3.796 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 99 | -2.28 units on a scale | Standard Deviation 2.9 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 113 | -2.03 units on a scale | Standard Deviation 3.185 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -1.35 units on a scale | Standard Deviation 1.556 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 3 | -1.49 units on a scale | Standard Deviation 1.694 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -1.40 units on a scale | Standard Deviation 2.069 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -4.02 units on a scale | Standard Deviation 3.467 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -1.75 units on a scale | Standard Deviation 1.828 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -1.77 units on a scale | Standard Deviation 2.326 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -2.04 units on a scale | Standard Deviation 2.214 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -2.59 units on a scale | Standard Deviation 2.278 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -2.62 units on a scale | Standard Deviation 2.268 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -3.02 units on a scale | Standard Deviation 2.464 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -2.33 units on a scale | Standard Deviation 2.565 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -2.46 units on a scale | Standard Deviation 2.54 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -1.81 units on a scale | Standard Deviation 3.188 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -2.54 units on a scale | Standard Deviation 2.509 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -2.78 units on a scale | Standard Deviation 2.275 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 2 | -0.85 units on a scale | Standard Deviation 1.607 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 3 | -1.21 units on a scale | Standard Deviation 1.702 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 4 | -1.26 units on a scale | Standard Deviation 1.862 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -2.63 units on a scale | Standard Deviation 2.62 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 5 | -1.58 units on a scale | Standard Deviation 1.865 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 6 | -1.49 units on a scale | Standard Deviation 2.317 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -2.03 units on a scale | Standard Deviation 3.378 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 7 | -1.75 units on a scale | Standard Deviation 2.159 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 8 | -2.39 units on a scale | Standard Deviation 2.294 |
| PF-04965842 100mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 9 | -2.40 units on a scale | Standard Deviation 2.154 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -2.73 units on a scale | Standard Deviation 2.515 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -2.47 units on a scale | Standard Deviation 2.533 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 3 | -1.92 units on a scale | Standard Deviation 2.3 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 13 | -3.88 units on a scale | Standard Deviation 3.085 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 2 | -1.00 units on a scale | Standard Deviation 2.433 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -1.60 units on a scale | Standard Deviation 2.345 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 113 | -1.50 units on a scale | Standard Deviation 3.736 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -5.30 units on a scale | Standard Deviation 2.957 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 12 | -3.63 units on a scale | Standard Deviation 3.154 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 3 | -1.48 units on a scale | Standard Deviation 2.493 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 99 | -1.90 units on a scale | Standard Deviation 3.767 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 85 | -4.84 units on a scale | Standard Deviation 3.785 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 57 | -5.26 units on a scale | Standard Deviation 3.13 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -2.15 units on a scale | Standard Deviation 3.909 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 4 | -2.12 units on a scale | Standard Deviation 2.59 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 9 | -3.18 units on a scale | Standard Deviation 2.988 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 43 | -5.02 units on a scale | Standard Deviation 3.172 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -1.50 units on a scale | Standard Deviation 3.816 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 8 | -3.22 units on a scale | Standard Deviation 3.039 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 5 | -2.35 units on a scale | Standard Deviation 2.583 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -4.28 units on a scale | Standard Deviation 2.841 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 29 | -5.00 units on a scale | Standard Deviation 2.88 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -5.06 units on a scale | Standard Deviation 2.817 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 11 | -3.40 units on a scale | Standard Deviation 3.071 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 6 | -2.53 units on a scale | Standard Deviation 2.648 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -4.50 units on a scale | Standard Deviation 2.648 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -5.14 units on a scale | Standard Deviation 3.645 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -3.68 units on a scale | Standard Deviation 2.591 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 15 | -4.37 units on a scale | Standard Deviation 2.696 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -3.74 units on a scale | Standard Deviation 2.633 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 14 | -4.06 units on a scale | Standard Deviation 2.793 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -3.54 units on a scale | Standard Deviation 3.018 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -3.69 units on a scale | Standard Deviation 2.808 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 10 | -3.38 units on a scale | Standard Deviation 2.975 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -3.84 units on a scale | Standard Deviation 2.932 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -3.15 units on a scale | Standard Deviation 2.739 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -3.24 units on a scale | Standard Deviation 2.446 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -5.59 units on a scale | Standard Deviation 3.037 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Itching due to AD Day 7 | -2.77 units on a scale | Standard Deviation 2.795 |
| PF-04965842 200mg QD | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -4.08 units on a scale | Standard Deviation 2.952 |
Secondary
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 1 | -7.910 units on a scale | Standard Deviation 12.4625 |
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 13 | -16.603 units on a scale | Standard Deviation 21.385 |
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 4 | -14.555 units on a scale | Standard Deviation 16.6414 |
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 14 | -17.987 units on a scale | Standard Deviation 22.0893 |
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 16 | -19.408 units on a scale | Standard Deviation 22.1744 |
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 12 | -18.647 units on a scale | Standard Deviation 20.0191 |
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 6 | -19.527 units on a scale | Standard Deviation 16.7869 |
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 2 | -10.905 units on a scale | Standard Deviation 15.4157 |
| Placebo | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 8 | -19.052 units on a scale | Standard Deviation 18.5735 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 14 | -15.842 units on a scale | Standard Deviation 19.5 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 8 | -18.853 units on a scale | Standard Deviation 21.7947 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 12 | -17.986 units on a scale | Standard Deviation 23.1948 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 13 | -16.895 units on a scale | Standard Deviation 22.1132 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 1 | -5.000 units on a scale | Standard Deviation 13.331 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 2 | -8.795 units on a scale | Standard Deviation 16.3883 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 16 | -18.925 units on a scale | Standard Deviation 21.5459 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 4 | -14.116 units on a scale | Standard Deviation 19.1643 |
| PF-04965842 10mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 6 | -16.667 units on a scale | Standard Deviation 21.8577 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 2 | -13.266 units on a scale | Standard Deviation 14.5268 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 6 | -19.930 units on a scale | Standard Deviation 17.5966 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 16 | -12.716 units on a scale | Standard Deviation 15.939 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 14 | -12.768 units on a scale | Standard Deviation 13.6914 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 1 | -8.388 units on a scale | Standard Deviation 14.6316 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 8 | -19.534 units on a scale | Standard Deviation 18.7098 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 12 | -21.211 units on a scale | Standard Deviation 17.6774 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 13 | -15.023 units on a scale | Standard Deviation 16.1573 |
| PF-04965842 30mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 4 | -15.496 units on a scale | Standard Deviation 16.4795 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 12 | -33.145 units on a scale | Standard Deviation 21.4221 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 1 | -12.024 units on a scale | Standard Deviation 12.4053 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 14 | -20.211 units on a scale | Standard Deviation 20.292 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 16 | -17.753 units on a scale | Standard Deviation 19.1842 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 2 | -20.286 units on a scale | Standard Deviation 15.2402 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 8 | -30.148 units on a scale | Standard Deviation 20.7887 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 6 | -29.729 units on a scale | Standard Deviation 21.6156 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 4 | -28.058 units on a scale | Standard Deviation 16.6775 |
| PF-04965842 100mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 13 | -24.261 units on a scale | Standard Deviation 19.4912 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 6 | -41.458 units on a scale | Standard Deviation 14.3943 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 14 | -21.292 units on a scale | Standard Deviation 17.7775 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 12 | -41.384 units on a scale | Standard Deviation 15.4359 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 4 | -39.567 units on a scale | Standard Deviation 14.7328 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 16 | -21.024 units on a scale | Standard Deviation 18.1576 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 8 | -42.604 units on a scale | Standard Deviation 13.9771 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 1 | -21.326 units on a scale | Standard Deviation 15.8867 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 2 | -32.152 units on a scale | Standard Deviation 14.4354 |
| PF-04965842 200mg QD | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | Week 13 | -29.884 units on a scale | Standard Deviation 19.1501 |
Secondary
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 12 | -2.6 units on a scale | Standard Deviation 3.01 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 1 | -0.5 units on a scale | Standard Deviation 2.71 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 8 | -0.7 units on a scale | Standard Deviation 3.31 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 2 | -1.5 units on a scale | Standard Deviation 2.87 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 4 | -0.5 units on a scale | Standard Deviation 3 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 8 | -1.7 units on a scale | Standard Deviation 2.33 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 16 | -2.9 units on a scale | Standard Deviation 3.75 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 12 | -0.9 units on a scale | Standard Deviation 3.96 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 14 | -2.3 units on a scale | Standard Deviation 3.43 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 16 | -0.7 units on a scale | Standard Deviation 3.18 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 4 | -1.6 units on a scale | Standard Deviation 3.18 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 2 | -0.5 units on a scale | Standard Deviation 2.78 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 14 | 0.1 units on a scale | Standard Deviation 3.41 |
| Placebo | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 1 | -1.0 units on a scale | Standard Deviation 2.66 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 14 | -1.2 units on a scale | Standard Deviation 3.5 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 1 | 0.2 units on a scale | Standard Deviation 2.41 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 16 | -1.1 units on a scale | Standard Deviation 3.59 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 16 | -2.2 units on a scale | Standard Deviation 3.38 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 1 | 0.0 units on a scale | Standard Deviation 2.38 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 12 | -1.5 units on a scale | Standard Deviation 2.85 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 2 | 0.4 units on a scale | Standard Deviation 2.99 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 8 | -1.6 units on a scale | Standard Deviation 2.67 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 8 | -1.3 units on a scale | Standard Deviation 3.76 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 4 | -1.0 units on a scale | Standard Deviation 2.8 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 12 | -0.9 units on a scale | Standard Deviation 3.65 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 14 | -1.5 units on a scale | Standard Deviation 3.17 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 2 | -0.4 units on a scale | Standard Deviation 2.56 |
| PF-04965842 10mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 4 | -0.4 units on a scale | Standard Deviation 3.26 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 8 | -1.4 units on a scale | Standard Deviation 3.21 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 4 | -0.8 units on a scale | Standard Deviation 2.05 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 1 | -0.6 units on a scale | Standard Deviation 2.49 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 8 | -0.9 units on a scale | Standard Deviation 2.84 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 12 | -0.5 units on a scale | Standard Deviation 2.83 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 14 | -0.9 units on a scale | Standard Deviation 1.53 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 16 | -1.0 units on a scale | Standard Deviation 1.85 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 1 | -0.2 units on a scale | Standard Deviation 2.49 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 2 | -0.9 units on a scale | Standard Deviation 2.88 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 4 | -0.7 units on a scale | Standard Deviation 2.69 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 2 | -1.1 units on a scale | Standard Deviation 1.85 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 12 | -1.0 units on a scale | Standard Deviation 3.43 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 14 | -1.4 units on a scale | Standard Deviation 2.96 |
| PF-04965842 30mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 16 | -0.7 units on a scale | Standard Deviation 3.27 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 14 | -1.7 units on a scale | Standard Deviation 4.31 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 14 | -2.0 units on a scale | Standard Deviation 3.49 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 2 | -1.7 units on a scale | Standard Deviation 2.81 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 12 | -2.4 units on a scale | Standard Deviation 3.74 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 4 | -1.7 units on a scale | Standard Deviation 2.95 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 8 | -2.1 units on a scale | Standard Deviation 3.35 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 8 | -2.7 units on a scale | Standard Deviation 3.44 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 4 | -1.5 units on a scale | Standard Deviation 3.35 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 2 | -1.2 units on a scale | Standard Deviation 2.93 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 12 | -2.8 units on a scale | Standard Deviation 3.71 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 1 | -0.9 units on a scale | Standard Deviation 2.94 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 16 | -1.4 units on a scale | Standard Deviation 3.93 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 16 | -1.4 units on a scale | Standard Deviation 3.85 |
| PF-04965842 100mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 1 | -1.1 units on a scale | Standard Deviation 2.26 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 16 | -0.1 units on a scale | Standard Deviation 3.57 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 1 | -1.0 units on a scale | Standard Deviation 2.16 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 12 | -1.8 units on a scale | Standard Deviation 3.9 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 2 | -2.4 units on a scale | Standard Deviation 3.15 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 14 | -0.1 units on a scale | Standard Deviation 4.18 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 8 | -1.7 units on a scale | Standard Deviation 3.08 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 14 | -1.5 units on a scale | Standard Deviation 3.93 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 12 | -2.5 units on a scale | Standard Deviation 3.51 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 4 | -2.4 units on a scale | Standard Deviation 4.04 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 1 | -1.2 units on a scale | Standard Deviation 2.71 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 4 | -2.1 units on a scale | Standard Deviation 3.3 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Depression score Week 2 | -1.8 units on a scale | Standard Deviation 2.66 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 16 | -1.5 units on a scale | Standard Deviation 3.1 |
| PF-04965842 200mg QD | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | Anxiety score Week 8 | -2.5 units on a scale | Standard Deviation 3.31 |
Secondary
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
Time frame: Baseline up to Week 16
Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of anemia | 0 participants |
| Placebo | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of neutropenia | 0 participants |
| Placebo | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of thrombocytopenia | 0 participants |
| Placebo | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lymphopenia | 0 participants |
| Placebo | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lipid profile | 0 participants |
| Placebo | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of liver function tests | 0 participants |
| PF-04965842 10mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lipid profile | 0 participants |
| PF-04965842 10mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of liver function tests | 0 participants |
| PF-04965842 10mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of anemia | 0 participants |
| PF-04965842 10mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of thrombocytopenia | 0 participants |
| PF-04965842 10mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lymphopenia | 0 participants |
| PF-04965842 10mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of neutropenia | 0 participants |
| PF-04965842 30mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lymphopenia | 0 participants |
| PF-04965842 30mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lipid profile | 0 participants |
| PF-04965842 30mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of anemia | 0 participants |
| PF-04965842 30mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of thrombocytopenia | 0 participants |
| PF-04965842 30mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of neutropenia | 0 participants |
| PF-04965842 30mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of liver function tests | 0 participants |
| PF-04965842 100mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lymphopenia | 0 participants |
| PF-04965842 100mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of neutropenia | 0 participants |
| PF-04965842 100mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of thrombocytopenia | 0 participants |
| PF-04965842 100mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of liver function tests | 0 participants |
| PF-04965842 100mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lipid profile | 0 participants |
| PF-04965842 100mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of anemia | 0 participants |
| PF-04965842 200mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lipid profile | 0 participants |
| PF-04965842 200mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of thrombocytopenia | 1 participants |
| PF-04965842 200mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of neutropenia | 1 participants |
| PF-04965842 200mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of liver function tests | 0 participants |
| PF-04965842 200mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of lymphopenia | 0 participants |
| PF-04965842 200mg QD | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | AEs of anemia | 0 participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline till Week 16
Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (AEs) | 32 participants |
| PF-04965842 10mg QD | Number of Participants With Treatment-emergent Adverse Events (AEs) | 34 participants |
| PF-04965842 30mg QD | Number of Participants With Treatment-emergent Adverse Events (AEs) | 34 participants |
| PF-04965842 100mg QD | Number of Participants With Treatment-emergent Adverse Events (AEs) | 43 participants |
| PF-04965842 200mg QD | Number of Participants With Treatment-emergent Adverse Events (AEs) | 41 participants |
Secondary
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 16 | 14.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 8 | 14.6 percentage of participants |
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 2 | 7.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 12 | 17.1 percentage of participants |
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 14 | 21.9 percentage of participants |
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 4 | 8.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 13 | 13.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 6 | 22.7 percentage of participants |
| Placebo | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 1 | 1.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 13 | 24.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 12 | 17.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 6 | 23.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 8 | 19.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 4 | 11.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 16 | 26.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 2 | 10.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 1 | 4.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 14 | 17.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 12 | 23.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 1 | 6.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 2 | 10.6 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 4 | 12.8 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 6 | 18.6 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 8 | 23.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 13 | 12.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 14 | 10.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 16 | 11.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 6 | 29.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 12 | 51.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 4 | 25.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 13 | 26.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 2 | 11.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 16 | 22.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 14 | 20.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 1 | 5.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 8 | 34.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 1 | 9.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 6 | 59.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 12 | 57.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 4 | 51.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 8 | 59.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 16 | 31.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 14 | 25.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 13 | 37.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | Week 2 | 24.0 percentage of participants |
Secondary
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10).
Time frame: Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 22.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 8.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 2.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 2.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 10.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 11.8 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 10.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 8.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 8.2 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 16.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 4.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 24.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 22.4 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 25.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 32.7 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 31.4 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 28.8 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 26.9 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 33.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 52.2 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 6.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 10.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 8.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 10.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 14.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 15.7 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 16.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 14.6 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 14.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 20.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 18.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 20.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 24.5 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 30.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 28.8 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 23.5 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 26.9 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 25.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 30.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 47.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 35.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 31.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 13.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 11.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 15.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 8.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 21.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 15.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 17.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 2.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 17.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 25.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 11.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 11.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 20.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 13.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 29.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 19.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 13.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 2.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 25.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 8.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 31.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 28.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 23.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 29.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 8.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 13.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 15.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 22.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 8.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 4.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 11.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 35.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 6.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 17.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 6.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 25.5 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 20.5 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 6.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 37.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 27.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 40.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 20.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 31.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 29.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 26.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 38.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 34.8 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 30.4 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 25.5 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 36.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 36.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 30.8 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 27.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 25.5 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 37.8 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 34.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 29.8 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 38.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 38.5 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 38.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 25.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 21.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 38.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 41.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 38.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 33.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 33.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 14.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 24.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 19.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 19.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 17.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 38.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 23.4 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 28.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 26.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 31.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 30.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 53.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 43.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 43.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 49.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 53.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 48.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 60.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 54.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 60.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 53.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 54.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 53.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 57.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 47.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 44.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 22.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 25.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 25.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 54.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 29.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 33.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 34.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 45.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 45.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 52.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 45.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 45.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 47.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 50.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 51.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 14.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 22.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 22.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 48.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 24.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 24.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 47.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 30.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 43.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 45.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 46.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 48.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 34.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 66.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 17.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 26.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 35.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 75.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 60.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 28.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 41.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 64.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 72.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 39.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 34.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 50.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 73.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 38.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 51.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 36.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 71.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 74.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 74.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 57.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 40.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 72.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 70.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 65.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 72.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 63.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 67.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 55.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 60.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 55.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 60.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 55.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 57.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 74.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 42.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 70.0 percentage of participants |
Secondary
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10).
Time frame: Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 10.6 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 15.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 10.4 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 14.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 6.1 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 24.5 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 10.2 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 8.2 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 4.2 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 2.1 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 34.8 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 19.6 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 17.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 12.8 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 2.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 16.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 10.6 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 6.5 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 20.7 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 8.5 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 10.4 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 4.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 12.5 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 2.1 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 6.4 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 2.1 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 2.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 16.3 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 43.5 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 27.6 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 25.5 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 6.1 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 20.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 17.6 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 20.0 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 17.6 percentage of participants |
| Placebo | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 8.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 6.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 20.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 4.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 6.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 2.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 2.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 0.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 2.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 2.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 8.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 4.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 6.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 13.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 11.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 6.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 14.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 7.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 13.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 22.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 22.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 22.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 25.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 20.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 0.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 2.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 0.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 4.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 2.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 6.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 8.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 15.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 13.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 15.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 16.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 15.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 15.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 24.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 20.5 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 25.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 18.5 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 22.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 31.6 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 35.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 25.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 23.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 17.4 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 26.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 23.8 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 33.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 23.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 19.6 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 28.6 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 16.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 7.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 11.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 17.4 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 19.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 16.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 19.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 13.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 33.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 23.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 26.8 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 31.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 6.5 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 23.8 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 26.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 28.6 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 29.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 26.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 30.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 20.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 21.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 35.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 19.6 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 14.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 23.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 20.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 25.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 19.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 25.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 35.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 41.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 29.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 53.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 29.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 32.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 52.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 36.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 24.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 51.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 21.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 50.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 10.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 30.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 13.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 47.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 52.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 28.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 29.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 25.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 34.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 50.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 29.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 20.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 36.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 32.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 38.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 38.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 20.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 41.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 27.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 34.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 39.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 36.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 58.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 34.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 11.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 14.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 14.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | 38.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | 52.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 22.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | 69.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 26.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 36.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 21.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | 44.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | 51.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | 61.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 54.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 15.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 48.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | 73.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | 44.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | 51.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | 55.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 44.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | 59.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | 54.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | 70.3 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | 35.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | 51.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | 68.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | 66.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | 71.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | 37.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | 66.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | 72.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | 26.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | 71.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | 63.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 32.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | 66.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 37.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | 72.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 31.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 28.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | 51.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 18.8 percentage of participants |
Secondary
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 16 | 39.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 8 | 23.6 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 2 | 5.5 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 12 | 19.2 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 14 | 31.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 4 | 20.0 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 13 | 26.7 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 6 | 21.8 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 1 | 3.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 13 | 20.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 12 | 13.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 6 | 16.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 8 | 22.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 4 | 12.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 16 | 30.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 2 | 10.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 1 | 2.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 14 | 17.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 12 | 15.6 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 1 | 6.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 2 | 10.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 4 | 16.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 6 | 26.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 8 | 30.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 13 | 16.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 14 | 3.4 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 16 | 14.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 6 | 45.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 12 | 50.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 4 | 43.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 13 | 34.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 2 | 18.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 16 | 25.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 14 | 32.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 1 | 7.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 8 | 43.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 1 | 29.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 6 | 74.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 12 | 72.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 4 | 75.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 8 | 73.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 16 | 34.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 14 | 36.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 13 | 48.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | Week 2 | 55.8 percentage of participants |
Secondary
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time frame: All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 16 | 42.9 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 8 | 30.9 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 2 | 27.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 12 | 26.9 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 14 | 37.5 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 4 | 27.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 13 | 43.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 6 | 36.4 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 1 | 9.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 13 | 41.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 12 | 26.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 6 | 30.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 8 | 36.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 4 | 30.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 16 | 42.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 2 | 16.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 1 | 8.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 14 | 42.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 12 | 33.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 1 | 14.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 2 | 24.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 4 | 36.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 6 | 40.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 8 | 40.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 13 | 45.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 14 | 37.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 16 | 33.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 6 | 60.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 12 | 55.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 4 | 58.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 13 | 55.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 2 | 36.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 16 | 41.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 14 | 50.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 1 | 12.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 8 | 60.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 1 | 40.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 6 | 90.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 12 | 79.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 4 | 85.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 8 | 90.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 16 | 68.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 14 | 65.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 13 | 75.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | Week 2 | 65.4 percentage of participants |
Secondary
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 16 | 14.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 8 | 3.6 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 12 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 14 | 15.6 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 4 | 1.8 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 13 | 13.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 6 | 5.5 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 1 | 0.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 13 | 10.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 12 | 10.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 6 | 12.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 8 | 6.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 4 | 4.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 16 | 11.5 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 2 | 2.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 1 | 2.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 14 | 7.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 12 | 0.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 1 | 2.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 2 | 2.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 4 | 4.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 6 | 4.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 8 | 2.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 13 | 0.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 14 | 0.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 16 | 0.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 6 | 20.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 12 | 18.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 4 | 14.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 13 | 18.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 2 | 3.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 16 | 11.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 14 | 12.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 1 | 1.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 8 | 16.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 1 | 3.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 6 | 37.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 12 | 37.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 4 | 27.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 8 | 35.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 16 | 2.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 14 | 11.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 13 | 15.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | Week 2 | 11.5 percentage of participants |
Secondary
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time frame: All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 16 | 32.1 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 8 | 20.0 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 2 | 5.5 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 12 | 15.4 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 14 | 31.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 4 | 10.9 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 13 | 26.7 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 6 | 16.4 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 1 | 3.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 13 | 27.6 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 12 | 17.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 6 | 18.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 8 | 22.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 4 | 18.4 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 16 | 38.5 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 2 | 12.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 1 | 2.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 14 | 25.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 12 | 13.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 1 | 6.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 2 | 6.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 4 | 20.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 6 | 18.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 8 | 22.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 13 | 12.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 14 | 6.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 16 | 3.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 6 | 38.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 12 | 40.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 4 | 27.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 13 | 36.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 2 | 12.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 16 | 25.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 14 | 35.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 1 | 3.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 8 | 40.0 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 1 | 16.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 6 | 68.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 12 | 64.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 4 | 57.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 8 | 73.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 16 | 36.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 14 | 45.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 13 | 55.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | Week 2 | 36.5 percentage of participants |
Secondary
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time frame: All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 16 | 14.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 8 | 5.5 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 12 | 9.6 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 14 | 15.6 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 4 | 1.8 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 13 | 10.0 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 6 | 7.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 1 | 0.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 13 | 13.8 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 12 | 10.9 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 6 | 14.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 8 | 12.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 4 | 8.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 16 | 23.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 2 | 6.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 1 | 2.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 14 | 14.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 12 | 0.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 1 | 4.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 2 | 4.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 4 | 8.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 6 | 14.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 8 | 8.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 13 | 3.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 14 | 0.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 16 | 3.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 6 | 16.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 12 | 25.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 4 | 10.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 13 | 23.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 2 | 5.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 16 | 8.3 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 14 | 17.5 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 1 | 0.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 8 | 23.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 1 | 7.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 6 | 44.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 12 | 52.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 4 | 38.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 8 | 43.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 16 | 10.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 14 | 18.2 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 13 | 31.1 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | Week 2 | 19.2 percentage of participants |
Secondary
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time frame: Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.
Population: Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 1 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 3.6 percentage of participants |
| Placebo | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 1.8 percentage of participants |
| Placebo | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 6 | 14.5 percentage of participants |
| Placebo | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 5.5 percentage of participants |
| Placebo | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 13 | 10.0 percentage of participants |
| Placebo | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 14 | 18.8 percentage of participants |
| Placebo | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 16 | 10.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 8.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 13 | 20.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 1 | 2.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 6 | 14.3 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 6.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 16 | 23.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 8.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 14 | 10.7 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 14 | 3.4 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 16 | 7.4 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 6 | 14.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 13 | 12.9 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 8.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 6.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 1 | 2.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 12.0 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 3.6 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 16.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 6 | 12.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 16.4 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 13 | 23.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 16 | 13.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 1 | 1.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 14 | 12.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 6 | 40.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 16 | 18.4 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 40.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 14 | 15.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 1 | 3.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 13 | 26.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 11.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 41.5 percentage of participants |
Secondary
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, severe (4), moderate (3), mild (2),almost clear (1), and clear (0). The PtGA was completed as per schedule of activities.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 1 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 2 | 5.6 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 4 | 3.8 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 6 | 3.8 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 8 | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 12 | 7.4 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 14 | 3.2 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 16 | 11.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 4 | 6.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 12 | 12.5 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 1 | 2.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 6 | 10.2 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 2 | 0.0 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 16 | 7.7 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 8 | 6.1 percentage of participants |
| PF-04965842 10mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 14 | 10.3 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 14 | 0.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 16 | 0.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 6 | 8.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 12 | 0.0 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 4 | 8.2 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 2 | 6.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 1 | 4.1 percentage of participants |
| PF-04965842 30mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 8 | 6.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 2 | 16.7 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 4 | 22.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 6 | 22.2 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 8 | 24.1 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 12 | 25.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 16 | 11.8 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 1 | 1.9 percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 14 | 15.8 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 6 | 51.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 16 | 10.5 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 4 | 54.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 14 | 15.6 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 1 | 16.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 12 | 51.9 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 2 | 32.7 percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | Week 8 | 56.6 percentage of participants |
Secondary
Percent Change From Baseline in SCORAD at All Scheduled Time Points
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Time frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 16 | -31.972 percent change | Standard Deviation 36.5058 |
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 8 | -29.624 percent change | Standard Deviation 30.5625 |
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 2 | -16.488 percent change | Standard Deviation 23.0011 |
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 12 | -29.379 percent change | Standard Deviation 31.9081 |
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 14 | -29.393 percent change | Standard Deviation 36.6642 |
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 4 | -22.476 percent change | Standard Deviation 26.5163 |
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 13 | -26.794 percent change | Standard Deviation 34.3384 |
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 6 | -30.789 percent change | Standard Deviation 27.9424 |
| Placebo | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 1 | -11.547 percent change | Standard Deviation 19.7128 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 13 | -26.905 percent change | Standard Deviation 34.1879 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 12 | -27.607 percent change | Standard Deviation 36.5015 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 6 | -25.851 percent change | Standard Deviation 34.295 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 8 | -28.599 percent change | Standard Deviation 33.146 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 4 | -20.751 percent change | Standard Deviation 29.0846 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 16 | -30.135 percent change | Standard Deviation 34.2361 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 2 | -12.980 percent change | Standard Deviation 25.5198 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 1 | -7.287 percent change | Standard Deviation 20.6403 |
| PF-04965842 10mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 14 | -25.511 percent change | Standard Deviation 31.1985 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 12 | -32.535 percent change | Standard Deviation 25.2711 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 1 | -13.068 percent change | Standard Deviation 21.0746 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 2 | -20.613 percent change | Standard Deviation 21.0283 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 4 | -24.866 percent change | Standard Deviation 25.3755 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 6 | -31.276 percent change | Standard Deviation 29.6517 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 8 | -30.480 percent change | Standard Deviation 29.4742 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 13 | -24.232 percent change | Standard Deviation 26.2461 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 14 | -20.072 percent change | Standard Deviation 21.7399 |
| PF-04965842 30mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 16 | -19.794 percent change | Standard Deviation 25.055 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 6 | -45.270 percent change | Standard Deviation 34.3893 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 12 | -51.624 percent change | Standard Deviation 33.0106 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 4 | -43.846 percent change | Standard Deviation 26.2001 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 13 | -38.193 percent change | Standard Deviation 32.3458 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 2 | -31.025 percent change | Standard Deviation 23.9881 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 16 | -29.130 percent change | Standard Deviation 33.1868 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 14 | -31.521 percent change | Standard Deviation 34.1268 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 1 | -19.185 percent change | Standard Deviation 20.0094 |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 8 | -46.187 percent change | Standard Deviation 32.7984 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 1 | -34.660 percent change | Standard Deviation 25.0837 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 6 | -66.971 percent change | Standard Deviation 22.4343 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 12 | -68.537 percent change | Standard Deviation 24.2392 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 4 | -63.970 percent change | Standard Deviation 21.6701 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 8 | -69.736 percent change | Standard Deviation 21.4403 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 16 | -34.995 percent change | Standard Deviation 27.4996 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 14 | -36.519 percent change | Standard Deviation 28.5404 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 13 | -48.428 percent change | Standard Deviation 30.1133 |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD at All Scheduled Time Points | Week 2 | -51.384 percent change | Standard Deviation 21.3581 |
Secondary
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time frame: Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 1 | -12.28 Percent change | Standard Deviation 27.205 |
| Placebo | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 2 | -23.54 Percent change | Standard Deviation 33.348 |
| Placebo | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 4 | -24.58 Percent change | Standard Deviation 40.52 |
| Placebo | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 6 | -39.17 Percent change | Standard Deviation 39.299 |
| Placebo | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 8 | -36.69 Percent change | Standard Deviation 42.629 |
| Placebo | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 13 | -29.82 Percent change | Standard Deviation 50.404 |
| Placebo | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 14 | -35.51 Percent change | Standard Deviation 43.357 |
| Placebo | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 16 | -35.91 Percent change | Standard Deviation 47.713 |
| PF-04965842 10mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 4 | -30.06 Percent change | Standard Deviation 40.852 |
| PF-04965842 10mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 13 | -34.11 Percent change | Standard Deviation 51.089 |
| PF-04965842 10mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 1 | -13.80 Percent change | Standard Deviation 26.526 |
| PF-04965842 10mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 6 | -35.18 Percent change | Standard Deviation 43.498 |
| PF-04965842 10mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 2 | -14.79 Percent change | Standard Deviation 40.474 |
| PF-04965842 10mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 16 | -45.24 Percent change | Standard Deviation 44.576 |
| PF-04965842 10mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 8 | -39.43 Percent change | Standard Deviation 46.27 |
| PF-04965842 10mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 14 | -31.54 Percent change | Standard Deviation 62.829 |
| PF-04965842 30mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 14 | -26.25 Percent change | Standard Deviation 49.184 |
| PF-04965842 30mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 16 | -20.80 Percent change | Standard Deviation 47.915 |
| PF-04965842 30mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 6 | -40.16 Percent change | Standard Deviation 43.849 |
| PF-04965842 30mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 13 | -32.97 Percent change | Standard Deviation 45.223 |
| PF-04965842 30mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 4 | -32.81 Percent change | Standard Deviation 40.255 |
| PF-04965842 30mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 2 | -26.29 Percent change | Standard Deviation 33.298 |
| PF-04965842 30mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 1 | -14.85 Percent change | Standard Deviation 33.721 |
| PF-04965842 30mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 8 | -36.83 Percent change | Standard Deviation 52.632 |
| PF-04965842 100mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 2 | -38.26 Percent change | Standard Deviation 39.176 |
| PF-04965842 100mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 4 | -53.59 Percent change | Standard Deviation 35.274 |
| PF-04965842 100mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 6 | -54.16 Percent change | Standard Deviation 53.212 |
| PF-04965842 100mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 8 | -53.96 Percent change | Standard Deviation 53.689 |
| PF-04965842 100mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 13 | -51.23 Percent change | Standard Deviation 45.968 |
| PF-04965842 100mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 16 | -27.66 Percent change | Standard Deviation 54.57 |
| PF-04965842 100mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 1 | -19.85 Percent change | Standard Deviation 30.379 |
| PF-04965842 100mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 14 | -38.80 Percent change | Standard Deviation 49.085 |
| PF-04965842 200mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 6 | -83.14 Percent change | Standard Deviation 17.267 |
| PF-04965842 200mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 16 | -55.82 Percent change | Standard Deviation 32.833 |
| PF-04965842 200mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 4 | -78.16 Percent change | Standard Deviation 20.666 |
| PF-04965842 200mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 14 | -57.15 Percent change | Standard Deviation 36.739 |
| PF-04965842 200mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 1 | -41.26 Percent change | Standard Deviation 32.064 |
| PF-04965842 200mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 13 | -66.34 Percent change | Standard Deviation 34.951 |
| PF-04965842 200mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 2 | -63.28 Percent change | Standard Deviation 25.754 |
| PF-04965842 200mg QD | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | Week 8 | -84.48 Percent change | Standard Deviation 16.226 |
Secondary
Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time frame: Baseline and Week 12
Population: Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 | -35.22 percent change | Standard Error 6.572 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 | -31.13 percent change | Standard Error 7.09 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 | -40.73 percent change | Standard Error 6.823 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 | -59.04 percent change | Standard Error 6.212 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 | -82.57 percent change | Standard Error 6.161 |
p-value: 0.673190% CI: [-11.88, 20.05]Mixed Models Analysis
p-value: 0.56190% CI: [-21.16, 10.13]Mixed Models Analysis
p-value: 0.009190% CI: [-38.76, -8.88]Mixed Models Analysis
p-value: <0.000190% CI: [-62.23, -32.47]Mixed Models Analysis
Secondary
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10).
Time frame: Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | -11.12 percent change | Standard Deviation 30.087 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | -1.32 percent change | Standard Deviation 22.63 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | -1.98 percent change | Standard Deviation 22.326 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | -2.98 percent change | Standard Deviation 22.385 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | -1.52 percent change | Standard Deviation 25.69 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | -4.18 percent change | Standard Deviation 30.531 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | -0.35 percent change | Standard Deviation 34.144 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | -2.56 percent change | Standard Deviation 30.688 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | -3.32 percent change | Standard Deviation 29.885 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | -7.81 percent change | Standard Deviation 30.201 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | 0.56 percent change | Standard Deviation 19.298 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | -15.16 percent change | Standard Deviation 29.759 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | -13.61 percent change | Standard Deviation 30.153 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | -17.24 percent change | Standard Deviation 30.755 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | -19.43 percent change | Standard Deviation 35.575 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | -26.55 percent change | Standard Deviation 36.418 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | -25.54 percent change | Standard Deviation 39.577 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | -30.10 percent change | Standard Deviation 42.697 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | -19.24 percent change | Standard Deviation 43.251 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | -31.99 percent change | Standard Deviation 45.929 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | 6.72 percent change | Standard Deviation 45.759 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 2.59 percent change | Standard Deviation 45.541 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | 3.73 percent change | Standard Deviation 37.683 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -0.70 percent change | Standard Deviation 34.834 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | 4.04 percent change | Standard Deviation 52.799 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -2.25 percent change | Standard Deviation 37.193 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | 1.22 percent change | Standard Deviation 38.544 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | 1.08 percent change | Standard Deviation 58.633 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -3.47 percent change | Standard Deviation 53.518 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -6.24 percent change | Standard Deviation 49.163 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -8.41 percent change | Standard Deviation 49.918 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -13.45 percent change | Standard Deviation 40.159 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -10.26 percent change | Standard Deviation 46.126 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -18.78 percent change | Standard Deviation 34.923 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -16.05 percent change | Standard Deviation 39.63 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -24.51 percent change | Standard Deviation 30.798 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -24.94 percent change | Standard Deviation 35.662 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -29.81 percent change | Standard Deviation 44.035 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -17.46 percent change | Standard Deviation 43.552 |
| Placebo | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -28.95 percent change | Standard Deviation 46.896 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -32.19 percent change | Standard Deviation 37.806 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | -21.60 percent change | Standard Deviation 44.446 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -5.41 percent change | Standard Deviation 32.491 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -3.90 percent change | Standard Deviation 25.515 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | -5.94 percent change | Standard Deviation 31.028 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -5.76 percent change | Standard Deviation 24.623 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | -22.47 percent change | Standard Deviation 48.291 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -5.88 percent change | Standard Deviation 32.75 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | -6.65 percent change | Standard Deviation 32.617 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | 0.23 percent change | Standard Deviation 17.314 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | -7.28 percent change | Standard Deviation 28.058 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | -15.94 percent change | Standard Deviation 42.332 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -3.56 percent change | Standard Deviation 25.414 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | -5.97 percent change | Standard Deviation 29.093 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -10.46 percent change | Standard Deviation 31.103 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | -4.59 percent change | Standard Deviation 28.248 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | -14.07 percent change | Standard Deviation 47.186 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | -8.84 percent change | Standard Deviation 29.474 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | -5.69 percent change | Standard Deviation 25.576 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | 2.48 percent change | Standard Deviation 21.994 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -16.22 percent change | Standard Deviation 38.055 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -6.67 percent change | Standard Deviation 19.016 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | -16.63 percent change | Standard Deviation 34.554 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -17.15 percent change | Standard Deviation 33.432 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -13.86 percent change | Standard Deviation 32.39 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -23.28 percent change | Standard Deviation 44.257 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | 0.30 percent change | Standard Deviation 24.33 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -8.79 percent change | Standard Deviation 26.589 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | -7.43 percent change | Standard Deviation 27.374 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -20.21 percent change | Standard Deviation 36.947 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | -5.70 percent change | Standard Deviation 23.478 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -3.25 percent change | Standard Deviation 15.23 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | -8.61 percent change | Standard Deviation 27.803 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | -27.15 percent change | Standard Deviation 39.55 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | -1.51 percent change | Standard Deviation 19.857 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -5.65 percent change | Standard Deviation 36.637 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -3.73 percent change | Standard Deviation 23.125 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -25.76 percent change | Standard Deviation 43.273 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -11.34 percent change | Standard Deviation 28.494 |
| PF-04965842 10mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | -2.37 percent change | Standard Deviation 20.174 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -3.36 percent change | Standard Deviation 52.153 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -14.84 percent change | Standard Deviation 38.256 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -28.55 percent change | Standard Deviation 43.421 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -5.65 percent change | Standard Deviation 51.132 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -17.05 percent change | Standard Deviation 40.108 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -19.05 percent change | Standard Deviation 36.488 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | -26.70 percent change | Standard Deviation 29.805 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -25.00 percent change | Standard Deviation 31.695 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -32.28 percent change | Standard Deviation 38.817 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -17.58 percent change | Standard Deviation 42.054 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | -18.07 percent change | Standard Deviation 33.64 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -19.84 percent change | Standard Deviation 47.884 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -18.73 percent change | Standard Deviation 42.599 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | -25.09 percent change | Standard Deviation 37.815 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | -16.76 percent change | Standard Deviation 49.412 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | -16.70 percent change | Standard Deviation 33.407 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | -28.41 percent change | Standard Deviation 36.183 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | -22.90 percent change | Standard Deviation 41.573 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | -18.92 percent change | Standard Deviation 31.846 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | -31.14 percent change | Standard Deviation 39.09 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -26.88 percent change | Standard Deviation 38.846 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | -29.60 percent change | Standard Deviation 39.606 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | -17.87 percent change | Standard Deviation 34.789 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | -12.18 percent change | Standard Deviation 33.385 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -26.48 percent change | Standard Deviation 46.793 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | -30.39 percent change | Standard Deviation 47.772 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | -27.84 percent change | Standard Deviation 33.416 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | -11.46 percent change | Standard Deviation 39.959 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -27.70 percent change | Standard Deviation 30.476 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | -8.22 percent change | Standard Deviation 33.257 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | -14.34 percent change | Standard Deviation 29.756 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -10.14 percent change | Standard Deviation 28.184 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | -3.96 percent change | Standard Deviation 49.425 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | -9.39 percent change | Standard Deviation 23.528 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -27.91 percent change | Standard Deviation 39.142 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -9.39 percent change | Standard Deviation 39.225 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | -24.56 percent change | Standard Deviation 30.086 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | -22.74 percent change | Standard Deviation 33.667 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -17.72 percent change | Standard Deviation 38.967 |
| PF-04965842 30mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -24.73 percent change | Standard Deviation 31.96 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -54.51 percent change | Standard Deviation 43.354 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | -31.93 percent change | Standard Deviation 27.094 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | -33.13 percent change | Standard Deviation 27.902 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | -33.30 percent change | Standard Deviation 34.252 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | -35.89 percent change | Standard Deviation 35.651 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | -36.57 percent change | Standard Deviation 27.552 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -49.94 percent change | Standard Deviation 36.649 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | -35.41 percent change | Standard Deviation 29.14 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | -46.62 percent change | Standard Deviation 40.09 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | -49.49 percent change | Standard Deviation 46.279 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | -54.11 percent change | Standard Deviation 36.374 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | -56.51 percent change | Standard Deviation 41.955 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -53.95 percent change | Standard Deviation 41.772 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | -32.68 percent change | Standard Deviation 34.789 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | -28.47 percent change | Standard Deviation 41.027 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -17.93 percent change | Standard Deviation 20.967 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | -19.98 percent change | Standard Deviation 22.91 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -20.71 percent change | Standard Deviation 24.391 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -55.39 percent change | Standard Deviation 35.447 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -23.69 percent change | Standard Deviation 24.954 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -26.47 percent change | Standard Deviation 27.218 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -27.80 percent change | Standard Deviation 32.466 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -35.44 percent change | Standard Deviation 29.791 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -35.17 percent change | Standard Deviation 29.637 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -38.87 percent change | Standard Deviation 29.184 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -33.23 percent change | Standard Deviation 26.95 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -34.93 percent change | Standard Deviation 27.181 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | -12.62 percent change | Standard Deviation 113.423 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -36.55 percent change | Standard Deviation 27.281 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -35.75 percent change | Standard Deviation 32.757 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | -10.06 percent change | Standard Deviation 25.93 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | -15.32 percent change | Standard Deviation 27.874 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | -17.62 percent change | Standard Deviation 25.747 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -38.28 percent change | Standard Deviation 27.724 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | -20.48 percent change | Standard Deviation 27.983 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | -21.58 percent change | Standard Deviation 27.842 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | -13.57 percent change | Standard Deviation 123.8 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | -23.02 percent change | Standard Deviation 33.524 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | -32.36 percent change | Standard Deviation 30.61 |
| PF-04965842 100mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | -31.82 percent change | Standard Deviation 30.951 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 5 | -35.45 percent change | Standard Deviation 37.436 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 4 | -28.27 percent change | Standard Deviation 47.925 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 3 | -16.46 percent change | Standard Deviation 67.794 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 13 | -49.77 percent change | Standard Deviation 48.426 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 2 | -6.79 percent change | Standard Deviation 47.751 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 2 | -10.52 percent change | Standard Deviation 79.18 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 113 | 24.61 percent change | Standard Deviation 190.848 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 43 | -69.24 percent change | Standard Deviation 38.37 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 12 | -46.40 percent change | Standard Deviation 46.241 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 3 | -16.72 percent change | Standard Deviation 40.055 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 99 | 5.61 percent change | Standard Deviation 139.223 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 85 | -53.66 percent change | Standard Deviation 109.454 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 57 | -70.13 percent change | Standard Deviation 36.338 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 99 | 2.12 percent change | Standard Deviation 144.572 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 4 | -25.80 percent change | Standard Deviation 38.557 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 9 | -39.37 percent change | Standard Deviation 41.055 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 43 | -67.80 percent change | Standard Deviation 36.372 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 113 | 27.77 percent change | Standard Deviation 203.937 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 8 | -43.13 percent change | Standard Deviation 38.684 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 5 | -30.91 percent change | Standard Deviation 34.215 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 14 | -57.50 percent change | Standard Deviation 39.073 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 29 | -68.09 percent change | Standard Deviation 31.214 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 29 | -67.84 percent change | Standard Deviation 29.918 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 11 | -42.50 percent change | Standard Deviation 51.621 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 6 | -34.02 percent change | Standard Deviation 35.532 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 15 | -60.99 percent change | Standard Deviation 32.84 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 85 | -54.54 percent change | Standard Deviation 120.723 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 10 | -49.78 percent change | Standard Deviation 37.349 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 15 | -59.00 percent change | Standard Deviation 39.804 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 11 | -51.62 percent change | Standard Deviation 37.385 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 14 | -55.45 percent change | Standard Deviation 34.331 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 9 | -44.29 percent change | Standard Deviation 43.238 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 8 | -46.26 percent change | Standard Deviation 43.491 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 10 | -39.60 percent change | Standard Deviation 56.607 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 12 | -51.92 percent change | Standard Deviation 40.01 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 7 | -40.19 percent change | Standard Deviation 39.702 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 6 | -44.31 percent change | Standard Deviation 36.476 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 57 | -73.50 percent change | Standard Deviation 30.583 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Itching due to AD Day 7 | -38.17 percent change | Standard Deviation 35.428 |
| PF-04965842 200mg QD | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | Frequency of itching due to AD Day 13 | -53.17 percent change | Standard Deviation 40.695 |
Secondary
Time to Achieving >=3 Points Improvement in NRS
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10).
Time frame: Baseline till Week 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Achieving >=3 Points Improvement in NRS | Itching due to AD | 30.0 day |
| Placebo | Time to Achieving >=3 Points Improvement in NRS | Frequency of itching due to AD | 29.0 day |
| PF-04965842 10mg QD | Time to Achieving >=3 Points Improvement in NRS | Itching due to AD | 43.0 day |
| PF-04965842 10mg QD | Time to Achieving >=3 Points Improvement in NRS | Frequency of itching due to AD | 43.0 day |
| PF-04965842 30mg QD | Time to Achieving >=3 Points Improvement in NRS | Itching due to AD | 12.0 day |
| PF-04965842 30mg QD | Time to Achieving >=3 Points Improvement in NRS | Frequency of itching due to AD | 13.0 day |
| PF-04965842 100mg QD | Time to Achieving >=3 Points Improvement in NRS | Frequency of itching due to AD | 8.0 day |
| PF-04965842 100mg QD | Time to Achieving >=3 Points Improvement in NRS | Itching due to AD | 9.0 day |
| PF-04965842 200mg QD | Time to Achieving >=3 Points Improvement in NRS | Itching due to AD | 7.0 day |
| PF-04965842 200mg QD | Time to Achieving >=3 Points Improvement in NRS | Frequency of itching due to AD | 4.0 day |
Secondary
Time to Achieving >=4 Points Improvement in NRS
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10).
Time frame: Baseline till Week 16
Population: Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Achieving >=4 Points Improvement in NRS | Itching due to atopic dermatitis | 78.0 day |
| Placebo | Time to Achieving >=4 Points Improvement in NRS | Frequency of itching due to atopic dermatitis | 59.0 day |
| PF-04965842 10mg QD | Time to Achieving >=4 Points Improvement in NRS | Itching due to atopic dermatitis | NA day |
| PF-04965842 10mg QD | Time to Achieving >=4 Points Improvement in NRS | Frequency of itching due to atopic dermatitis | NA day |
| PF-04965842 30mg QD | Time to Achieving >=4 Points Improvement in NRS | Itching due to atopic dermatitis | 43.0 day |
| PF-04965842 30mg QD | Time to Achieving >=4 Points Improvement in NRS | Frequency of itching due to atopic dermatitis | 29.0 day |
| PF-04965842 100mg QD | Time to Achieving >=4 Points Improvement in NRS | Frequency of itching due to atopic dermatitis | 14.0 day |
| PF-04965842 100mg QD | Time to Achieving >=4 Points Improvement in NRS | Itching due to atopic dermatitis | 14.0 day |
| PF-04965842 200mg QD | Time to Achieving >=4 Points Improvement in NRS | Itching due to atopic dermatitis | 10.0 day |
| PF-04965842 200mg QD | Time to Achieving >=4 Points Improvement in NRS | Frequency of itching due to atopic dermatitis | 7.0 day |