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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005513-72 | EudraCT Number |
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Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 10 mg of PF-04965842 QD |
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| Cohort 2 | Experimental | 30 mg of PF-04965842 QD |
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| Cohort 3 | Experimental | 100 mg of PF-04965842 QD |
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| Cohort 4 | Experimental | 200 mg of PF-04965842 QD |
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| Cohort 5 | Placebo Comparator | placebo QD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04965842 | Drug | 10 mg of PF-04965842 QD for 12 weeks |
| |
| PF-04965842 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 | The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. |
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Inclusion Criteria:
Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
Must have the following atopic dermatitis criteria:
Exclusion Criteria:
Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.
Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| California Dermatology & Clinical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39104653 | Derived | Silverberg JI, Thyssen JP, Lazariciu I, Myers DE, Guler E, Chovatiya R. Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis. Skin Health Dis. 2024 May 5;4(4):e382. doi: 10.1002/ski2.382. eCollection 2024 Aug. | |
| 38896380 | Derived | Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 269 participants were randomized. There were 2 participants who were randomized but did not receive any study treatment. All other participants were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo tablets for a 12-week double-blind treatment period. |
| FG001 | PF-04965842 10mg QD | Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2017 | Feb 23, 2018 |
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| Drug |
30 mg of PF-04965842 QD for 12 weeks |
|
| PF-04965842 | Drug | 100 mg of PF-04965842 QD for 12 weeks |
|
| PF-04965842 | Drug | 200 mg of PF-04965842 QD for 12 weeks |
|
| Placebo | Drug | Placebo QD for 12 weeks |
|
| Baseline and Week 12 |
| Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). | Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16. |
| Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16 |
| Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 |
| Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 |
| Time to Achieving >=3 Points Improvement in NRS | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | Baseline till Week 16 |
| Time to Achieving >=4 Points Improvement in NRS | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | Baseline till Week 16 |
| Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 |
| Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 |
| Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Change From Baseline in Affected BSA at All Scheduled Time Points | BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Percent Change From Baseline in SCORAD at All Scheduled Time Points | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
| Number of Participants With Treatment-emergent Adverse Events (AEs) | An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state. | Baseline till Week 16 |
| Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | Baseline up to Week 16 |
| Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 |
| Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 |
| Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 |
| Encinitas |
| California |
| 92024 |
| United States |
| Huntington Medical Foundation | Pasadena | California | 91105 | United States |
| Peninsula Research Associates, Inc. | Rolling Hills Estates | California | 90274 | United States |
| Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery | Sacramento | California | 95819 | United States |
| TCR Medical Corporation | San Diego | California | 92123 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| University of Connecticut Health Center (UConn Health) | Farmington | Connecticut | 06032 | United States |
| Olympian Clinical Research | Clearwater | Florida | 33756 | United States |
| North Florida Dermatology Associates, PA | Jacksonville | Florida | 32204 | United States |
| Park Avenue Dermatology Administration Annex | Orange Park | Florida | 32073 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| Leavitt Medical Associates of Florida d/b/a Ameriderm Research | Ormond Beach | Florida | 32174 | United States |
| Forward Clinical Trials, Inc. | Tampa | Florida | 33624 | United States |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | United States |
| Dundee Dermatology | West Dundee | Illinois | 60118 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Dawes Fretzin Dermatology Group, LLC | Indianapolis | Indiana | 46256 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| DS Research | Louisville | Kentucky | 40241 | United States |
| Shondra L Smith, MD Dermatology & Advanced Aesthetics | Lake Charles | Louisiana | 70605 | United States |
| Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | United States |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| The Dermatology Group, P.C | Verona | New Jersey | 07044 | United States |
| Forest Hills Dermatology Group | Forest Hills | New York | 11375 | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| Vital Prospects Clinical Research Institute, P.C | Tulsa | Oklahoma | 74136 | United States |
| DermDox Centers for Dermatology | Hazleton | Pennsylvania | 18201 | United States |
| UPMC Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Virginia Clinical Research,Inc | Norfolk | Virginia | 23502 | United States |
| West End Dermatology Associates | Richmond | Virginia | 23233 | United States |
| Woden Dermatology | Phillip | Australian Capital Territory | 2606 | Australia |
| Australian Clinical Research Network | Sydney | New South Wales | 2035 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Veracity Clinical Research | Woolloongabba | Queensland | 4102 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | 6160 | Australia |
| North Eastern Health Specialists | Hectorville, South Australia | 5073 | Australia |
| University of British Columbia | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| Research by ICLS | Oakville | Ontario | L6J 7W5 | Canada |
| Skin Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| The Centre for Dermatology | Richmond Hill | Ontario | L4B IA5 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Windsor Clinical Research Inc | Windsor | Ontario | N8W 5L7 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2K 4L5 | Canada |
| Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) | Québec | Quebec | G1V 4X7 | Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| ISA GmbH | Berlin | 10789 | Germany |
| Universitaetsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
| Bacs Kiskun Megyei Korhaz, Bor es Nemibeteggondozo | Kecskemét | 6000 | Hungary |
| CRU Hungary Ltd., MISEK-CRU | Miskolc | 3529 | Hungary |
| Szegedi Tudomanyegyetem SzentGyorgyi Albert Klinikai Kozpont Borgyogyaszati es Allergologiai Klinika | Szeged | 6720 | Hungary |
| Allergo-Derm Bakos Kft. | Szolnok | 5000 | Hungary |
| 37988255 | Derived | Schmid-Grendelmeier P, Gooderham MJ, Hartmann K, Konstantinou GN, Fellmann M, Koulias C, Clibborn C, Biswas P, Brunner PM. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. Allergy. 2024 Jan;79(1):174-183. doi: 10.1111/all.15952. Epub 2023 Nov 21. |
| 37949351 | Derived | Alexis AF, Silverberg JI, Rice ZP, Armstrong AW, Desai SR, Fonacier L, Kabashima K, Biswas P, Cella RR, Chan GL, Levenberg M. Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type. Ann Allergy Asthma Immunol. 2024 Mar;132(3):383-389.e3. doi: 10.1016/j.anai.2023.11.002. Epub 2023 Nov 10. |
| 35933552 | Derived | Gooderham MJ, Girolomoni G, Moore JO, Silverberg JI, Bissonnette R, Forman S, Peeva E, Biswas P, Valdez H, Chan G. Durability of Response to Abrocitinib in Patients with Moderate-to-Severe Atopic Dermatitis After Treatment Discontinuation in a Phase 2b Trial. Dermatol Ther (Heidelb). 2022 Sep;12(9):2077-2085. doi: 10.1007/s13555-022-00764-4. Epub 2022 Aug 7. |
| 35763326 | Derived | Blauvelt A, Boguniewicz M, Brunner PM, Luna PC, Biswas P, DiBonaventura M, Farooqui SA, Rojo R, Cameron MC. Abrocitinib monotherapy in Investigator's Global Assessment nonresponders: improvement in signs and symptoms of atopic dermatitis and quality of life. J Dermatolog Treat. 2022 Aug;33(5):2605-2613. doi: 10.1080/09546634.2022.2059053. Epub 2022 Jul 6. |
| 35462428 | Derived | Stander S, Bhatia N, Gooderham MJ, Silverberg JI, Thyssen JP, Biswas P, DiBonaventura M, Romero W, Farooqui SA. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 Aug;36(8):1308-1317. doi: 10.1111/jdv.18170. Epub 2022 May 6. |
| 35342978 | Derived | Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11. |
| 35061234 | Derived | Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21. |
| 34406619 | Derived | Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18. |
| 33954933 | Derived | Silverberg JI, Thyssen JP, Simpson EL, Yosipovitch G, Stander S, Valdez H, Rojo R, Biswas P, Myers DE, Feeney C, DiBonaventura M. Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes. Am J Clin Dermatol. 2021 Jul;22(4):541-554. doi: 10.1007/s40257-021-00604-9. Epub 2021 May 5. |
| 33795561 | Derived | Simpson EL, Wollenberg A, Bissonnette R, Silverberg JI, Papacharalambous J, Zhu L, Zhang W, Beebe JS, Vincent M, Peeva E, Bushmakin AG, Cappelleri JC, Chen L, Sikirica V, Xenakis J. Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. Dermatitis. 2021 Oct 1;32(1S):S53-S61. doi: 10.1097/DER.0000000000000725. |
| 31577341 | Derived | Gooderham MJ, Forman SB, Bissonnette R, Beebe JS, Zhang W, Banfield C, Zhu L, Papacharalambous J, Vincent MS, Peeva E. Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2019 Dec 1;155(12):1371-1379. doi: 10.1001/jamadermatol.2019.2855. |
| FG002 | PF-04965842 30mg QD | Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| FG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| FG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
| COMPLETED |
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| NOT COMPLETED |
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The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo tablets for a 12-week double-blind treatment period. |
| BG001 | PF-04965842 10mg QD | Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. |
| BG002 | PF-04965842 30mg QD | Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| BG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| BG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 | The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). | "Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Least Squares Mean | Standard Error | percentage of participants | Baseline and Week 12 |
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| Secondary | Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | "Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Week 12 |
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| Secondary | Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). | "Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16. |
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| Secondary | Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points | The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively). | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | Percent change | Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16 |
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| Secondary | Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 |
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| Secondary | Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 |
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| Secondary | Time to Achieving >=3 Points Improvement in NRS | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Median | 90% Confidence Interval | day | Baseline till Week 16 |
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| Secondary | Time to Achieving >=4 Points Improvement in NRS | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Median | 90% Confidence Interval | day | Baseline till Week 16 |
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| Secondary | Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | percent change | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 |
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| Secondary | Change From Baseline in Pruritus NRS Score at All Scheduled Time Points | The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10). | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113 |
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| Secondary | Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points | The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Change From Baseline in Affected BSA at All Scheduled Time Points | BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | percentage of BSA | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Percent Change From Baseline in SCORAD at All Scheduled Time Points | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | percent change | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points | SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs) | An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state. | Safety Analysis Set: All participants who received at least 1 dose of study treatment. | Posted | Number | participants | Baseline till Week 16 |
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| Secondary | Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) | Safety Analysis Set: All participants who received at least 1 dose of study treatment. | Posted | Number | participants | Baseline up to Week 16 |
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| Secondary | Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Number | percentage of participants | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points | The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points | The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points | The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | "Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16 |
|
Baseline up to Week 16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo tablets for a 12-week double-blind treatment period. | 0 | 56 | 2 | 56 | 17 | 56 |
| EG001 | PF-04965842 10mg QD | Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. | 0 | 49 | 2 | 49 | 18 | 49 |
| EG002 | PF-04965842 30mg QD | Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. | 0 | 51 | 0 | 51 | 25 | 51 |
| EG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. | 0 | 56 | 3 | 56 | 25 | 56 |
| EG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. | 0 | 55 | 2 | 55 | 27 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema herpeticum | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 22, 2015 | Feb 23, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634427 | abrocitinib |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
| Emax model |
Emax model with non-responder imputation (NRI) |
| 0.1065 |
| Estimate difference |
| 6.0 |
| Standard Error of the Mean |
| 3.05 |
| 2-Sided |
| 95 |
| -1.8 |
| 13.8 |
Test group: PF-04965842 30 mg QD, Reference group: Placebo. |
| Other |
| Emax model | Emax model with non-responder imputation (NRI) | 0.0184 | Estimate difference | 21.5 | Standard Error of the Mean | 6.25 | 2-Sided | 95 | 5.5 | 37.6 | Test group: PF-04965842 100 mg QD, Reference group: Placebo. | Other |
| Emax model | Emax model with non-responder imputation (NRI) | 0.0032 | Mean Difference (Final Values) | 38.2 | Standard Error of the Mean | 7.18 | 2-Sided | 95 | 19.7 | 56.6 | Test group: PF-04965842 200 mg QD, Reference group: Placebo. | Other |
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
|
| PF-04965842 100mg QD |
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. |
| OG002 | PF-04965842 30mg QD | Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
| OG002 | PF-04965842 30mg QD | Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. |
| OG002 | PF-04965842 30mg QD | Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. |
| OG002 | PF-04965842 30mg QD | Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
| OG002 | PF-04965842 30mg QD | Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. |
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
| PF-04965842 100mg QD |
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
|
|
| OG003 | PF-04965842 100mg QD | Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. |
| OG004 | PF-04965842 200mg QD | Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. |
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