Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, JAK1 inhibitor
Brief summary
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderate to severe AD.
Detailed description
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderate to severe AD. Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Subjects must have moderate-severe AD involving at least 10% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of at least 3; an Eczema Area Severity Index (EASI) of at least 16 and Peak Pruritus Numerical Rating Score (NRS) of at least 4 on baseline/Day 1. Eligible subjects will be randomized at the Baseline/Day 1 visit. Approximately 225 participants will be randomized in a 1:1:1 ratio to receive once daily PF 04965842 at 200 mg, 100 mg, or placebo for 12 weeks. Randomization will be stratified by baseline disease severity (moderate \[IGA = 3\] vs. severe \[IGA = 4\] AD). The investigational products will be administered QD for 12 weeks. Background therapy (medicated and non-medicated topical therapy) must be applied BID for the duration of the treatment period. The co-primary efficacy endpoints are an IGA score of clear (0) or almost clear (1) with a reduction from baseline of greater than 2 points at Week 12 AND an at least 75% improvement of the EASI score (EASI-75) at week 12. Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment. Scheduled clinic or telephone study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8 (by phone), Day 15, Day 29, Day 43 (by phone), Day 57, Day 85 (End of treatment/Early termination), Day 113 (End of Study). Participants discontinuing early from the study will undergo a 4 week follow up period. This study includes an immunogenicity sub study integrated into the last 4 weeks of the main study treatment period. At Week 8, up to approximately 90 participants (up to approximately 30 in each treatment arm) who have completed 8 weeks of treatment with study intervention will receive a tetanus, diphtheria and acellular pertussis combination vaccine (Tdap), and collection of blood samples for the evaluation of immunogenicity at Weeks 8 and 12. Participants of this sub study will complete all other protocol specified procedures in the main study. At the end of the 12 week study treatment, qualified participants completing the study will have the option to enter the long term extension (LTE) study B7451015.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 12 and to 17 with a minimum body weight of 40 kg * Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
Exclusion criteria
* Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation * Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study * Prior treatment with JAK inhibitors * Other active non-AD inflammatory skin diseases or conditions affecting skin * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator * Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | Baseline to Week 12 | The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. |
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | Baseline to Week 12 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. 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. Participants who withdrew from the study were counted as non-responder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Baseline, Weeks 2, 4 and 12 | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms no itch (0) and worst itch imaginable (10). Participants who withdrew from the study were counted as non-responder. |
| Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | Baseline to Week 12 | The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms. |
| Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Baseline, Weeks 2, 4 and 8 | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. |
| Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Baseline, Weeks 2, 4 and 8 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder. |
| Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Baseline, Weeks 2, 4, 8 and 12 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder. |
| Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Baseline, Weeks 2, 4, 8 and 12 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder. |
| Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Baseline, Weeks 2, 4, 8 and 12 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder. |
| Percent Change From Baseline in EASI Score | Baseline, Weeks 2, 4, 8 and 12 | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder. |
| Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms no itch (0) and worst itch imaginable (10). Participants who withdrew from the study were counted as non-responder. |
| Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | Baseline to Week 16 | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms no itch (0) and worst itch imaginable (10). |
| Percent Change From Baseline in PP-NRS for Severity of Pruritus | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms no itch (0) and worst itch imaginable (10). |
| Change From Baseline in Percentage Body Surface Area (BSA) | Baseline, Weeks 2, 4, 8 and 12 | 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. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. |
| Percent Change From Baseline in Percentage BSA | Baseline, Weeks 2, 4, 8 and 12 | 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. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. |
| Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | Baseline to Week 12 | 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. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. |
| Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Baseline, Weeks 2, 4, 8 and 12 | 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 participant using a 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).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 SCORAD Response ≥ 75% Improvement From Baseline | Baseline, Weeks 2, 4, 8 and 12 | 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 participant using a 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).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. |
| Change From Baseline in SCORAD Total Score | Baseline, Weeks 2, 4, 8 and 12 | 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 participant using a 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).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 Total Score | Baseline, Weeks 2, 4, 8 and 12 | 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 participant using a 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).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. |
| Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Baseline, Weeks 2, 4, 8 and 12 | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where 0 is no itch (or no sleep loss) and 10 is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. |
| Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Baseline, Weeks 2, 4, 8 and 12 | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where 0 is no itch (or no sleep loss) and 10 is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. |
| Number of Days When a Corticosteroid Not Used up to Day 88 | Baseline to Day 88 | — |
| Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Baseline, Weeks 2, 4, 8 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).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 3-5 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. Participants who withdrew from the study were counted as non-responder. |
| Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Baseline, Weeks 2, 4, 8 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).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 3-5 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. Participants who withdrew from the study were counted as non-responder. |
| Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Baseline, Weeks 2, 4, 8 and 12 | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. 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. |
| Change From Baseline in Depression of HADS | Baseline, Weeks 2, 4, 8 and 12 | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. 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. |
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Baseline, Weeks 2, 4, 8 and 12 | The POEM is a 7-item 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 Dermatitis Family Impact (DFI) at Week 12 | Baseline to Week 12 | The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as very much (3), a lot (2), a little (1) or not at all (0). The score can range from 0 to 30. The higher values represent the worse impact. |
| Change From Baseline in Patient Global Assessment (PtGA) | Baseline, Weeks 2, 4, 8 and 12 | 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 IGA were 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. |
| Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Baseline, Weeks 2, 4, 8 and 12 | 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 IGA were 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 EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Baseline, Weeks 2, 4, 8 and 12 | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). |
| Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | Baseline to Week 12 | The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 16 weeks | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. |
| Number of Participants With Serious Adverse Events (SAEs) | 16 weeks | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. |
| Number of Participants Who Discontinued From the Study Due to TEAEs | 16 weeks | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | 16 weeks | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | 16 weeks | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to \>500 ms or \>60 ms change from screening ECG); data are presented below. |
| Categorization of Vital Signs Data Meeting Prespecified Criteria | 16 weeks | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. |
| Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | 4 weeks post-vaccination with Tdap (Week 12) | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to \<18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. |
| Plasma PF-04965842 Concentration at Week 8 | 2 hours pre-dose at Week 8 | — |
| Plasma PF-04965842 Concentration at Week 12 | 2 hours post-dose at Week 12 | — |
Countries
Australia, China, Czechia, Germany, Hungary, Italy, Japan, Latvia, Mexico, Poland, Spain, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 287 adolescent participants were randomized to the study, and 285 adolescent participants received study treatment, including 96 participants in the placebo group, 95 participants in the abrocitinib 100 mg QD group, and 94 participants in the abrocitinib 200 mg QD group.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received two PF-04965842-matching placebo tablets QD | 96 |
| PF-04965842 100mg QD Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD | 95 |
| PF-04965842 200mg QD Participants received two PF-04965842 100 mg tablets QD | 94 |
| Total | 285 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 2 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 |
| Overall Study | Participant did not complete Week 16 due to COVID-19 impact | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | PF-04965842 200mg QD | Total | PF-04965842 100mg QD |
|---|---|---|---|---|
| Age, Continuous | 14.8 Years STANDARD_DEVIATION 1.7 | 14.7 Years STANDARD_DEVIATION 1.8 | 14.9 Years STANDARD_DEVIATION 1.7 | 15.1 Years STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 25 Participants | 76 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 69 Participants | 197 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 12 Participants | 6 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 4 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 32 Participants | 31 Participants | 94 Participants | 31 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 5 Participants | 17 Participants | 9 Participants |
| Race/Ethnicity, Customized Multiracial | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Not reported | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 56 Participants | 52 Participants | 160 Participants | 52 Participants |
| Sex: Female, Male Female | 52 Participants | 38 Participants | 140 Participants | 50 Participants |
| Sex: Female, Male Male | 44 Participants | 56 Participants | 145 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 95 | 0 / 94 |
| other Total, other adverse events | 42 / 96 | 40 / 95 | 50 / 94 |
| serious Total, serious adverse events | 2 / 96 | 0 / 95 | 1 / 94 |
Outcome results
Primary
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. 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. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline to Week 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | 41.5 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | 68.5 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | 72.0 Percentage of participants |
p-value: 0.000295% CI: [13.1, 39.8]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [16.3, 42.5]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12
The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline to Week 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | 24.5 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | 41.6 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | 46.2 Percentage of participants |
p-value: 0.014795% CI: [3.5, 29.9]Cochran-Mantel-Haenszel
p-value: 0.00395% CI: [7.3, 33.9]Cochran-Mantel-Haenszel
Secondary
Categorization of Vital Signs Data Meeting Prespecified Criteria
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.
Time frame: 16 weeks
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Decrease From Baseline >= 20mmHg | 3 Participants |
| Placebo | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Increase From Baseline >=30mmHg | 2 Participants |
| Placebo | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Decrease From Baseline >=30mmHg | 2 Participants |
| Placebo | Categorization of Vital Signs Data Meeting Prespecified Criteria | Pulse Rate Value <40 bpm | 0 Participants |
| Placebo | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Increase From Baseline >= 20mmHg | 3 Participants |
| Placebo | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Value <90mmHg | 4 Participants |
| Placebo | Categorization of Vital Signs Data Meeting Prespecified Criteria | Pulse Rate Value >120 bpm | 0 Participants |
| Placebo | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Value <50mmHg | 3 Participants |
| PF-04965842 100mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Pulse Rate Value >120 bpm | 0 Participants |
| PF-04965842 100mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Increase From Baseline >=30mmHg | 1 Participants |
| PF-04965842 100mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Increase From Baseline >= 20mmHg | 6 Participants |
| PF-04965842 100mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Decrease From Baseline >=30mmHg | 1 Participants |
| PF-04965842 100mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Decrease From Baseline >= 20mmHg | 4 Participants |
| PF-04965842 100mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Value <50mmHg | 1 Participants |
| PF-04965842 100mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Pulse Rate Value <40 bpm | 0 Participants |
| PF-04965842 100mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Value <90mmHg | 7 Participants |
| PF-04965842 200mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Decrease From Baseline >=30mmHg | 2 Participants |
| PF-04965842 200mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Value <50mmHg | 9 Participants |
| PF-04965842 200mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Increase From Baseline >= 20mmHg | 6 Participants |
| PF-04965842 200mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Diastolic Blood Pressure Decrease From Baseline >= 20mmHg | 8 Participants |
| PF-04965842 200mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Pulse Rate Value <40 bpm | 0 Participants |
| PF-04965842 200mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Value <90mmHg | 4 Participants |
| PF-04965842 200mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Systolic Blood Pressure Increase From Baseline >=30mmHg | 2 Participants |
| PF-04965842 200mg QD | Categorization of Vital Signs Data Meeting Prespecified Criteria | Pulse Rate Value >120 bpm | 0 Participants |
Secondary
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. 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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 2 | -1.2 Units on a scale |
| Placebo | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 4 | -1.5 Units on a scale |
| Placebo | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 8 | -1.7 Units on a scale |
| Placebo | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 12 | -2.1 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 12 | -2.0 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 2 | -1.6 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 8 | -2.1 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 4 | -1.6 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 12 | -2.4 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 4 | -1.9 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 8 | -2.2 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Week 2 | -1.3 Units on a scale |
Secondary
Change From Baseline in Children's Dermatology Life Quality Index (DLQI)
The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).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 3-5 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. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 2 | -4.2 Units on a scale |
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 4 | -5.4 Units on a scale |
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 8 | -6.1 Units on a scale |
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 12 | -6.3 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 12 | -8.6 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 2 | -6.1 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 8 | -8.1 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 4 | -7.3 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 12 | -8.7 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 4 | -7.6 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 8 | -8.2 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Week 2 | -6.3 Units on a scale |
Secondary
Change From Baseline in Depression of HADS
The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. 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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Depression of HADS | Week 12 | -1.0 Units on a scale |
| Placebo | Change From Baseline in Depression of HADS | Week 8 | -1.1 Units on a scale |
| Placebo | Change From Baseline in Depression of HADS | Week 2 | -0.8 Units on a scale |
| Placebo | Change From Baseline in Depression of HADS | Week 4 | -0.8 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Depression of HADS | Week 2 | -1.2 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Depression of HADS | Week 4 | -1.3 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Depression of HADS | Week 8 | -1.4 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Depression of HADS | Week 12 | -1.4 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Depression of HADS | Week 8 | -1.2 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Depression of HADS | Week 2 | -0.8 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Depression of HADS | Week 4 | -1.3 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Depression of HADS | Week 12 | -1.2 Units on a scale |
Secondary
Change From Baseline in Dermatitis Family Impact (DFI) at Week 12
The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as very much (3), a lot (2), a little (1) or not at all (0). The score can range from 0 to 30. The higher values represent the worse impact.
Time frame: Baseline to Week 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 | -5.2 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 | -6.7 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 | -7.3 Units on a scale |
Secondary
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score
The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 2 | 7.140 Units on a scale |
| Placebo | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 4 | 8.784 Units on a scale |
| Placebo | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 8 | 8.415 Units on a scale |
| Placebo | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 12 | 9.944 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 12 | 14.226 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 2 | 11.241 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 8 | 14.502 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 4 | 13.222 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 12 | 15.756 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 4 | 14.677 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 8 | 14.653 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Week 2 | 12.141 Units on a scale |
Secondary
Change From Baseline in Patient Global Assessment (PtGA)
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 IGA were 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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Assessment (PtGA) | Week 8 | -0.8 Units on a scale |
| Placebo | Change From Baseline in Patient Global Assessment (PtGA) | Week 4 | -0.7 Units on a scale |
| Placebo | Change From Baseline in Patient Global Assessment (PtGA) | Week 2 | -0.4 Units on a scale |
| Placebo | Change From Baseline in Patient Global Assessment (PtGA) | Week 12 | -0.9 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Patient Global Assessment (PtGA) | Week 4 | -0.9 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Patient Global Assessment (PtGA) | Week 2 | -0.7 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Patient Global Assessment (PtGA) | Week 12 | -1.4 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Patient Global Assessment (PtGA) | Week 8 | -1.2 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Patient Global Assessment (PtGA) | Week 2 | -1.0 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Patient Global Assessment (PtGA) | Week 12 | -1.6 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Patient Global Assessment (PtGA) | Week 8 | -1.4 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Patient Global Assessment (PtGA) | Week 4 | -1.2 Units on a scale |
Secondary
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
The POEM is a 7-item 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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 2 | -3.4 Units on a scale |
| Placebo | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 4 | -4.8 Units on a scale |
| Placebo | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 8 | -5.4 Units on a scale |
| Placebo | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 12 | -6.9 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 12 | -11.1 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 2 | -6.9 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 8 | -10.0 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 4 | -9.5 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 12 | -10.9 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 4 | -10.6 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 8 | -10.6 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Week 2 | -8.2 Units on a scale |
Secondary
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.
Time frame: Baseline to Week 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | 2.5 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | 4.5 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | 4.3 Units on a scale |
Secondary
Change From Baseline in Percentage Body Surface Area (BSA)
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. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Percentage Body Surface Area (BSA) | Week 2 | -10.9 Units on a scale |
| Placebo | Change From Baseline in Percentage Body Surface Area (BSA) | Week 4 | -15.1 Units on a scale |
| Placebo | Change From Baseline in Percentage Body Surface Area (BSA) | Week 8 | -21.8 Units on a scale |
| Placebo | Change From Baseline in Percentage Body Surface Area (BSA) | Week 12 | -24.2 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Percentage Body Surface Area (BSA) | Week 12 | -34.4 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Percentage Body Surface Area (BSA) | Week 2 | -21.0 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Percentage Body Surface Area (BSA) | Week 8 | -32.6 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Percentage Body Surface Area (BSA) | Week 4 | -27.7 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Percentage Body Surface Area (BSA) | Week 8 | -34.1 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Percentage Body Surface Area (BSA) | Week 4 | -32.6 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Percentage Body Surface Area (BSA) | Week 12 | -35.2 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Percentage Body Surface Area (BSA) | Week 2 | -20.7 Units on a scale |
Secondary
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.
Time frame: Baseline to Week 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | -2.0 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | -2.5 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | -2.7 Units on a scale |
p-value: 0.066495% CI: [-1.1, 0]Mixed Models Analysis
p-value: 0.014295% CI: [-1.3, -0.1]Mixed Models Analysis
Secondary
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss
SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where 0 is no itch (or no sleep loss) and 10 is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 2 | -0.9 Units on a scale |
| Placebo | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 4 | -1.8 Units on a scale |
| Placebo | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 8 | -2.2 Units on a scale |
| Placebo | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 12 | -2.7 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 12 | -3.5 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 2 | -2.1 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 8 | -3.3 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 4 | -2.9 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 12 | -3.9 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 4 | -3.4 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 8 | -3.7 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Week 2 | -2.6 Units on a scale |
Secondary
Change From Baseline in SCORAD Total Score
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 participant using a 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).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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in SCORAD Total Score | Week 2 | -12.3 Units on a scale |
| Placebo | Change From Baseline in SCORAD Total Score | Week 4 | -20.2 Units on a scale |
| Placebo | Change From Baseline in SCORAD Total Score | Week 8 | -26.6 Units on a scale |
| Placebo | Change From Baseline in SCORAD Total Score | Week 12 | -30.2 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in SCORAD Total Score | Week 12 | -40.9 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in SCORAD Total Score | Week 2 | -24.6 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in SCORAD Total Score | Week 8 | -37.3 Units on a scale |
| PF-04965842 100mg QD | Change From Baseline in SCORAD Total Score | Week 4 | -32.4 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in SCORAD Total Score | Week 12 | -42.9 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in SCORAD Total Score | Week 4 | -38.0 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in SCORAD Total Score | Week 8 | -41.5 Units on a scale |
| PF-04965842 200mg QD | Change From Baseline in SCORAD Total Score | Week 2 | -25.8 Units on a scale |
Secondary
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination
The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to \<18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.
Time frame: 4 weeks post-vaccination with Tdap (Week 12)
Population: The immunogenicity sub-study analysis set included all participants who had completed 8 weeks of treatment and received Tdap vaccination. Number of Participants Analyzed refers to the number of participants evaluable in the analysis set at the specified visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Diphtheria IgG Antibody | 14.00 Ratio |
| Placebo | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Filamentous Hemagglutinin IgG | 15.19 Ratio |
| Placebo | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Fimbriae 2/3 IgG | 1.93 Ratio |
| Placebo | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Pertactin IgG | 54.03 Ratio |
| Placebo | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Pertussis Toxin IgG | 6.94 Ratio |
| Placebo | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Tetanus Toxoid IGG AB | 8.36 Ratio |
| PF-04965842 100mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Tetanus Toxoid IGG AB | 16.26 Ratio |
| PF-04965842 100mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Diphtheria IgG Antibody | 6.51 Ratio |
| PF-04965842 100mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Pertactin IgG | 15.60 Ratio |
| PF-04965842 100mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Pertussis Toxin IgG | 10.17 Ratio |
| PF-04965842 100mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Filamentous Hemagglutinin IgG | 11.48 Ratio |
| PF-04965842 100mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Fimbriae 2/3 IgG | 1.11 Ratio |
| PF-04965842 200mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Filamentous Hemagglutinin IgG | 22.77 Ratio |
| PF-04965842 200mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Fimbriae 2/3 IgG | 1.47 Ratio |
| PF-04965842 200mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Tetanus Toxoid IGG AB | 48.41 Ratio |
| PF-04965842 200mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Pertactin IgG | 60.18 Ratio |
| PF-04965842 200mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Diphtheria IgG Antibody | 34.61 Ratio |
| PF-04965842 200mg QD | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Pertussis Toxin IgG | 33.16 Ratio |
Secondary
Number of Days When a Corticosteroid Not Used up to Day 88
Time frame: Baseline to Day 88
Population: The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The analysis population included all participants in the FAS who had used corticosteroid during treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Number of Days When a Corticosteroid Not Used up to Day 88 | 6.8 Days |
| PF-04965842 100mg QD | Number of Days When a Corticosteroid Not Used up to Day 88 | 10.9 Days |
| PF-04965842 200mg QD | Number of Days When a Corticosteroid Not Used up to Day 88 | 15.1 Days |
Secondary
Number of Participants Who Discontinued From the Study Due to TEAEs
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Time frame: 16 weeks
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Discontinued From the Study Due to TEAEs | All-causality TEAEs | 2 Participants |
| Placebo | Number of Participants Who Discontinued From the Study Due to TEAEs | Treatment-related TEAEs | 0 Participants |
| PF-04965842 100mg QD | Number of Participants Who Discontinued From the Study Due to TEAEs | All-causality TEAEs | 1 Participants |
| PF-04965842 100mg QD | Number of Participants Who Discontinued From the Study Due to TEAEs | Treatment-related TEAEs | 0 Participants |
| PF-04965842 200mg QD | Number of Participants Who Discontinued From the Study Due to TEAEs | All-causality TEAEs | 2 Participants |
| PF-04965842 200mg QD | Number of Participants Who Discontinued From the Study Due to TEAEs | Treatment-related TEAEs | 2 Participants |
Secondary
Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria
A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to \>500 ms or \>60 ms change from screening ECG); data are presented below.
Time frame: 16 weeks
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | QTcF Interval, Single Beat (msec) Value >500 | 0 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | QTcF Interval, Single Beat (msec) Change From Screening >60 | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | QTcF Interval, Single Beat (msec) Value >500 | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | QTcF Interval, Single Beat (msec) Change From Screening >60 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | QTcF Interval, Single Beat (msec) Value >500 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | QTcF Interval, Single Beat (msec) Change From Screening >60 | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.
Time frame: 16 weeks
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants with at least one observation of the given laboratory test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Eosinophils (10^3/mm^3) >1.2*ULN | 63 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Protein >=1 | 4 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Eosinophils/Leukocytes (%) >1.2*ULN | 61 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Sodium (mEq/L) >1.05*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes (10^3/mm^3) >1.2*ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Granular Casts (/LPF) >1 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Sodium (mEq/L) <0.95*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2*ULN | 7 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Ketones >=1 | 8 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Triglycerides (mg/dL) >1.3*ULN | 17 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | LDL Cholesterol (mg/dL) >1.2*ULN | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Prothrombin Time (sec) >1.1*ULN | 4 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urate (mg/dL) >1.2*ULN | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Prothrombin Intl.Normalized Ratio >1.1*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Glucose >=1 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3*ULN | 3 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bilirubin (mg/dL) >1.5*ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) <0.5*LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Hemoglobin (g/dL) <0.8*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Albumin (g/dL) >1.2*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Indirect Bilirubin (mg/dL) >1.5*ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine pH (Scalar) >8 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Albumin (g/dL) <0.8*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Aspartate Aminotransferase (U/L) >3.0*ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Protein (g/dL) >1.2*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Alanine Aminotransferase (U/L) >3.0*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Protein (g/dL) <0.8*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Gamma Glutamyl Transferase (U/L) >3.0*ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine pH (Scalar) <4.5 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Alkaline Phosphatase (U/L) >3.0*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lactate Dehydrogenase (U/L) >3.0*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Specific Gravity (scalar) >1.030 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) <0.6*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Specific Gravity (scalar) <1.003 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Erythrocytes (/HPF) >=20 | 8 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) >1.5*ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Cholesterol (mg/dL)>1.3*ULN | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) <0.8*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Bacteria >20 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Creatine Kinase (U/L) >2.0*ULN | 5 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Leukocyte Esterase >=1 | 7 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) <0.8*LLN | 6 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) >1.2*ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Hyaline Casts (/LPF) >1 | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) >1.1*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) <0.8*LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Nitrite >=1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9*LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) >1.2*ULN | 6 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9*LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) <0.8*LLN | 5 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Hemoglobin >=1 | 20 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Chloride (mEq/L) >1.1*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Basophils (10^3/mm^3) >1.2*ULN | 3 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Basophils/Leukocytes (%) >1.2*ULN | 35 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Hematocrit (%) <0.8*LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1*ULN | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Hemoglobin (g/dL) <0.8*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9*LLN | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) <0.8*LLN | 4 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) <0.8*LLN | 2 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) >1.2*ULN | 5 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) <0.8*LLN | 3 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Basophils/Leukocytes (%) >1.2*ULN | 24 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Eosinophils (10^3/mm^3) >1.2*ULN | 55 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Eosinophils/Leukocytes (%) >1.2*ULN | 62 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2*ULN | 11 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 4 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Prothrombin Time (sec) >1.1*ULN | 6 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Prothrombin Intl.Normalized Ratio >1.1*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bilirubin (mg/dL) >1.5*ULN | 4 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Indirect Bilirubin (mg/dL) >1.5*ULN | 2 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Aspartate Aminotransferase (U/L) >3.0*ULN | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Alanine Aminotransferase (U/L) >3.0*ULN | 3 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Gamma Glutamyl Transferase (U/L) >3.0*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lactate Dehydrogenase (U/L) >3.0*ULN | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Alkaline Phosphatase (U/L) >3.0*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3*ULN | 2 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urate (mg/dL) >1.2*ULN | 4 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | LDL Cholesterol (mg/dL) >1.2*ULN | 2 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Triglycerides (mg/dL) >1.3*ULN | 11 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Sodium (mEq/L) <0.95*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Sodium (mEq/L) >1.05*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Chloride (mEq/L) >1.1*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9*LLN | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) >1.1*ULN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Glucose (mg/dL) >1.5*ULN | 2 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Creatine Kinase (U/L) >2.0*ULN | 7 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Cholesterol (mg/dL)>1.3*ULN | 2 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Specific Gravity (scalar) <1.003 | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Specific Gravity (scalar) >1.030 | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine pH (Scalar) >8 | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Glucose >=1 | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Ketones >=1 | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Protein >=1 | 5 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Hemoglobin >=1 | 19 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Nitrite >=1 | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Leukocyte Esterase >=1 | 14 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Erythrocytes (/HPF) >=20 | 7 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Leukocytes (/HPF) >=20 | 2 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Granular Casts (/LPF) >1 | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Hyaline Casts (/LPF) >1 | 1 Participants |
| PF-04965842 100mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Bacteria >20 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Basophils/Leukocytes (%) >1.2*ULN | 27 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Protein >=1 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Chloride (mEq/L) >1.1*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) <0.8*LLN | 7 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) >1.2*ULN | 3 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Hemoglobin (g/dL) <0.8*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) <0.8*LLN | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Hemoglobin >=1 | 15 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) >1.2*ULN | 4 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) >1.1*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) <0.8*LLN | 6 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Granular Casts (/LPF) >1 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Nitrite >=1 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Glucose (mg/dL) >1.5*ULN | 3 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) <0.8*LLN | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Creatine Kinase (U/L) >2.0*ULN | 12 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Cholesterol (mg/dL)>1.3*ULN | 2 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Leukocyte Esterase >=1 | 17 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) >1.5*ULN | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Specific Gravity (scalar) <1.003 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Bacteria >20 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lactate Dehydrogenase (U/L) >3.0*ULN | 2 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Gamma Glutamyl Transferase (U/L) >3.0*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Specific Gravity (scalar) >1.030 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Alkaline Phosphatase (U/L) >3.0*ULN | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Alanine Aminotransferase (U/L) >3.0*ULN | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Aspartate Aminotransferase (U/L) >3.0*ULN | 3 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Erythrocytes (/HPF) >=20 | 5 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Protein (g/dL) >1.2*ULN | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Albumin (g/dL) >1.2*ULN | 3 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Prothrombin Intl.Normalized Ratio >1.1*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine pH (Scalar) >8 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Prothrombin Time (sec) >1.1*ULN | 8 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urate (mg/dL) >1.2*ULN | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 4 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Hyaline Casts (/LPF) >1 | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | LDL Cholesterol (mg/dL) >1.2*ULN | 3 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2*ULN | 6 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Glucose >=1 | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Triglycerides (mg/dL) >1.3*ULN | 13 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Sodium (mEq/L) <0.95*LLN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Eosinophils/Leukocytes (%) >1.2*ULN | 47 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Leukocytes (/HPF) >=20 | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Sodium (mEq/L) >1.05*ULN | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Eosinophils (10^3/mm^3) >1.2*ULN | 39 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine Ketones >=1 | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9*LLN | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Time frame: 16 weeks
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Serious Adverse Events (SAEs) | All-causality SAEs | 2 Participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs) | Treatment-related SAEs | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Serious Adverse Events (SAEs) | All-causality SAEs | 0 Participants |
| PF-04965842 100mg QD | Number of Participants With Serious Adverse Events (SAEs) | Treatment-related SAEs | 0 Participants |
| PF-04965842 200mg QD | Number of Participants With Serious Adverse Events (SAEs) | All-causality SAEs | 1 Participants |
| PF-04965842 200mg QD | Number of Participants With Serious Adverse Events (SAEs) | Treatment-related SAEs | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Time frame: 16 weeks
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | All-causality TEAEs | 50 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment-related TEAEs | 16 Participants |
| PF-04965842 100mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | All-causality TEAEs | 54 Participants |
| PF-04965842 100mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment-related TEAEs | 20 Participants |
| PF-04965842 200mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | All-causality TEAEs | 59 Participants |
| PF-04965842 200mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment-related TEAEs | 31 Participants |
Secondary
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms no itch (0) and worst itch imaginable (10). Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 4 | 20.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 2 | 12.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 12 | 29.8 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 4 | 31.5 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 2 | 27.2 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 12 | 52.6 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 2 | 38.6 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 12 | 55.4 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Week 4 | 50.0 Percentage of participants |
p-value: 0.011995% CI: [3.5, 25.9]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [13.9, 38.3]Cochran-Mantel-Haenszel
p-value: 0.097195% CI: [-1.8, 23.6]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [16, 42.9]Cochran-Mantel-Haenszel
p-value: 0.003595% CI: [8, 37.7]Cochran-Mantel-Haenszel
p-value: 0.001395% CI: [10.6, 40.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms no itch (0) and worst itch imaginable (10). Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 12 | 10.8 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 7 | 10.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 4 | 4.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 11 | 7.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 8 | 4.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 3 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 10 | 8.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 9 | 6.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 13 | 10.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 5 | 6.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 15 | 14.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 2 | 1.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 6 | 8.8 Percentage of participants |
| Placebo | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 14 | 9.5 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 12 | 22.2 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 2 | 2.8 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 3 | 5.1 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 4 | 11.5 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 5 | 12.2 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 6 | 16.0 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 7 | 16.0 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 8 | 17.3 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 9 | 16.0 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 10 | 15.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 11 | 20.8 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 13 | 26.3 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 14 | 24.7 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 15 | 27.7 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 14 | 32.4 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 11 | 27.0 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 6 | 21.3 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 5 | 18.5 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 12 | 23.6 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 4 | 14.3 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 2 | 3.9 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 13 | 31.2 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 3 | 7.7 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 9 | 25.0 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 8 | 25.0 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 15 | 37.8 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 10 | 28.8 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Day 7 | 21.3 Percentage of participants |
Secondary
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 8 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 12 | 2.1 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 12 | 2.2 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 2 | 1.1 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 8 | 3.3 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 4 | 2.2 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 12 | 8.6 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 4 | 5.3 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 8 | 9.8 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Week 2 | 0 Percentage of participants |
Secondary
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 2 | 24.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 4 | 51.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 8 | 65.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 12 | 69.1 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 12 | 87.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 2 | 55.4 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 8 | 85.7 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 4 | 75.0 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 12 | 87.1 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 4 | 81.9 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 8 | 82.6 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Week 2 | 64.9 Percentage of participants |
Secondary
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4 and 8
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 14.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 4.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 33.3 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 41.3 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 19.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 60.4 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 25.5 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 68.5 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 63.8 Percentage of participants |
Secondary
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 4 | 2.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 8 | 14.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 12 | 18.1 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 12 | 41.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 2 | 8.7 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 8 | 29.7 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 4 | 17.4 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 12 | 49.5 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 4 | 30.9 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 8 | 40.2 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Week 2 | 10.6 Percentage of participants |
Secondary
Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4 and 8
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 1.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 16.0 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 19.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 6.5 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 30.8 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 2 | 12.8 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 8 | 48.9 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Week 4 | 38.3 Percentage of participants |
Secondary
Percentage of Participants Achieving Percentage BSA < 5% at Week 12
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. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time frame: Baseline to Week 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | 24.5 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | 38.2 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | 36.6 Percentage of participants |
Secondary
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline
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 participant using a 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).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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 12 | 12.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 8 | 8.5 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 8 | 17.2 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 2 | 5.4 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 12 | 36.7 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 4 | 11.8 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 12 | 34.8 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 4 | 21.7 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 2 | 7.5 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Week 8 | 33.7 Percentage of participants |
Secondary
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline
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 participant using a 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).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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 2 | 8.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 4 | 24.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 8 | 34.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 12 | 37.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 12 | 75.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 2 | 22.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 8 | 65.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 4 | 44.1 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 12 | 73.9 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 4 | 64.1 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 8 | 75.0 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Week 2 | 29.0 Percentage of participants |
Secondary
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI
The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).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 3-5 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. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 8 | 71.0 Percentage of participants |
| Placebo | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 12 | 67.7 Percentage of participants |
| Placebo | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 2 | 61.5 Percentage of participants |
| Placebo | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 4 | 73.7 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 2 | 73.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 12 | 80.9 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 8 | 85.9 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 4 | 82.4 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 12 | 78.5 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 4 | 73.4 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 8 | 79.6 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Week 2 | 71.3 Percentage of participants |
Secondary
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA
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 IGA were 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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 2 | 1.1 Percentage of participants |
| Placebo | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 4 | 4.2 Percentage of participants |
| Placebo | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 8 | 6.4 Percentage of participants |
| Placebo | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 12 | 10.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 12 | 30.0 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 2 | 5.4 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 8 | 22.6 Percentage of participants |
| PF-04965842 100mg QD | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 4 | 14.1 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 12 | 36.6 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 4 | 20.2 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 8 | 26.9 Percentage of participants |
| PF-04965842 200mg QD | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Week 2 | 5.3 Percentage of participants |
Secondary
Percent Change From Baseline in EASI Score
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. 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. Participants who withdrew from the study were counted as non-responder.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in EASI Score | Week 2 | -27.6 Percent change |
| Placebo | Percent Change From Baseline in EASI Score | Week 4 | -41.7 Percent change |
| Placebo | Percent Change From Baseline in EASI Score | Week 8 | -57.6 Percent change |
| Placebo | Percent Change From Baseline in EASI Score | Week 12 | -63.7 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in EASI Score | Week 12 | -77.3 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in EASI Score | Week 2 | -51.5 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in EASI Score | Week 8 | -72.6 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in EASI Score | Week 4 | -66.1 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in EASI Score | Week 12 | -80.6 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in EASI Score | Week 4 | -74.3 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in EASI Score | Week 8 | -77.8 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in EASI Score | Week 2 | -54.5 Percent change |
Secondary
Percent Change From Baseline in Percentage BSA
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. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Percentage BSA | Week 2 | -20.6 Percent change |
| Placebo | Percent Change From Baseline in Percentage BSA | Week 4 | -29.0 Percent change |
| Placebo | Percent Change From Baseline in Percentage BSA | Week 8 | -46.0 Percent change |
| Placebo | Percent Change From Baseline in Percentage BSA | Week 12 | -53.4 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in Percentage BSA | Week 12 | -71.4 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in Percentage BSA | Week 2 | -40.4 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in Percentage BSA | Week 8 | -65.7 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in Percentage BSA | Week 4 | -55.4 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in Percentage BSA | Week 12 | -72.6 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in Percentage BSA | Week 4 | -66.0 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in Percentage BSA | Week 8 | -69.5 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in Percentage BSA | Week 2 | -42.2 Percent change |
Secondary
Percent Change From Baseline in PP-NRS for Severity of Pruritus
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms no itch (0) and worst itch imaginable (10).
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 12 | -11.0 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 7 | -12.3 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 4 | -5.0 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 11 | -10.7 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 8 | -10.6 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 3 | -1.1 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 10 | -10.8 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 9 | -9.9 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 13 | -14.1 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 5 | -9.5 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 15 | -15.8 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 2 | -0.9 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 6 | -8.7 Percent change |
| Placebo | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 14 | -12.0 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 12 | -27.0 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 2 | -9.5 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 3 | -11.3 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 4 | -14.6 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 5 | -16.1 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 6 | -18.5 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 7 | -20.0 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 8 | -21.6 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 9 | -20.9 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 10 | -26.1 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 11 | -26.5 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 13 | -25.2 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 14 | -29.4 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 15 | -30.7 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 14 | -35.3 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 11 | -26.3 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 6 | -18.7 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 5 | -17.6 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 12 | -28.9 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 4 | -14.7 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 2 | -5.4 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 13 | -32.5 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 3 | -10.2 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 9 | -21.7 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 8 | -22.7 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 15 | -33.4 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 10 | -28.0 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Day 7 | -18.8 Percent change |
Secondary
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss
SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where 0 is no itch (or no sleep loss) and 10 is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 2 | 2.6 Percent change |
| Placebo | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 4 | -20.0 Percent change |
| Placebo | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 8 | -24.7 Percent change |
| Placebo | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 12 | -39.5 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 12 | -49.8 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 2 | 65.1 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 8 | -44.2 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 4 | -35.2 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 12 | -35.2 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 4 | -53.4 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 8 | -30.6 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Week 2 | -36.5 Percent change |
Secondary
Percent Change From Baseline in SCORAD Total Score
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 participant using a 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).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, Weeks 2, 4, 8 and 12
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in SCORAD Total Score | Week 2 | -18.7 Percent change |
| Placebo | Percent Change From Baseline in SCORAD Total Score | Week 4 | -30.0 Percent change |
| Placebo | Percent Change From Baseline in SCORAD Total Score | Week 8 | -39.9 Percent change |
| Placebo | Percent Change From Baseline in SCORAD Total Score | Week 12 | -44.4 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD Total Score | Week 12 | -59.2 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD Total Score | Week 2 | -36.1 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD Total Score | Week 8 | -54.0 Percent change |
| PF-04965842 100mg QD | Percent Change From Baseline in SCORAD Total Score | Week 4 | -47.4 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD Total Score | Week 12 | -64.3 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD Total Score | Week 4 | -56.9 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD Total Score | Week 8 | -62.0 Percent change |
| PF-04965842 200mg QD | Percent Change From Baseline in SCORAD Total Score | Week 2 | -38.7 Percent change |
Secondary
Plasma PF-04965842 Concentration at Week 12
Time frame: 2 hours post-dose at Week 12
Population: The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Plasma PF-04965842 Concentration at Week 12 | 486.6 ng/mL | Standard Deviation 403.69 |
| PF-04965842 100mg QD | Plasma PF-04965842 Concentration at Week 12 | 1271 ng/mL | Standard Deviation 1000.4 |
Secondary
Plasma PF-04965842 Concentration at Week 8
Time frame: 2 hours pre-dose at Week 8
Population: The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Plasma PF-04965842 Concentration at Week 8 | 7.882 ng/mL | Standard Deviation 26.35 |
| PF-04965842 100mg QD | Plasma PF-04965842 Concentration at Week 8 | 32.33 ng/mL | Standard Deviation 76.506 |
Secondary
Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms no itch (0) and worst itch imaginable (10).
Time frame: Baseline to Week 16
Population: The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants in the FAS with a baseline numeric rating score for severity of pruritus \>=4 were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | 90.0 Days |
| PF-04965842 100mg QD | Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | 70.0 Days |
| PF-04965842 200mg QD | Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | 29.0 Days |