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Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04965842
PF-04965842
PF-04965842
PF-04965842
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Phase 2, randomized, double-blind, placebo, atopic dermatitis, safety, efficacy, JAK, janus kinase, moderate, severe

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.

  • Must have the following atopic dermatitis criteria:

    1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
    2. Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
    3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).

Exclusion Criteria:

  • History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
  • Infected with hepatitis B or hepatitis C viruses.
  • Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
  • Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.

Sites / Locations

  • Clinical Research Center of Alabama
  • California Dermatology & Clinical Research Institute
  • Huntington Medical Foundation
  • Peninsula Research Associates, Inc.
  • Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery
  • TCR Medical Corporation
  • Clinical Science Institute
  • University of Connecticut Health Center (UConn Health)
  • Olympian Clinical Research
  • North Florida Dermatology Associates, PA
  • Park Avenue Dermatology Administration Annex
  • Park Avenue Dermatology
  • Leavitt Medical Associates of Florida d/b/a Ameriderm Research
  • Forward Clinical Trials, Inc.
  • MedaPhase, Inc.
  • Dundee Dermatology
  • Dawes Fretzin Clinical Research Group, LLC
  • Dawes Fretzin Dermatology Group, LLC
  • The Indiana Clinical Trials Center
  • DS Research
  • Shondra L Smith, MD Dermatology & Advanced Aesthetics
  • Somerset Skin Centre
  • MediSearch Clinical Trials
  • Clinical Research Consortium
  • Psoriasis Treatment Center of Central New Jersey
  • The Dermatology Group, P.C
  • Forest Hills Dermatology Group
  • Sadick Research Group
  • Vital Prospects Clinical Research Institute, P.C
  • DermDox Centers for Dermatology
  • UPMC Department of Dermatology
  • Clinical Partners, LLC
  • Health Concepts
  • Bellaire Dermatology Associates
  • Texas Dermatology and Laser Specialists
  • Virginia Clinical Research,Inc
  • West End Dermatology Associates
  • Woden Dermatology
  • Australian Clinical Research Network
  • The Skin Centre
  • Veracity Clinical Research
  • Sinclair Dermatology
  • Royal Melbourne Hospital
  • Fremantle Dermatology
  • North Eastern Health Specialists
  • University of British Columbia
  • Wiseman Dermatology Research Inc.
  • Lynderm Research Inc.
  • Research by ICLS
  • Skin Centre for Dermatology
  • The Centre for Dermatology
  • K. Papp Clinical Research
  • Windsor Clinical Research Inc
  • Innovaderm Research Inc.
  • Diex Research Sherbrooke Inc.
  • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
  • ISA GmbH
  • Universitaetsklinikum Schleswig-Holstein
  • Universitaetsklinikum Muenster
  • Universitaetsklinikum Tuebingen
  • Bacs Kiskun Megyei Korhaz, Bor es Nemibeteggondozo
  • CRU Hungary Ltd., MISEK-CRU
  • Szegedi Tudomanyegyetem SzentGyorgyi Albert Klinikai Kozpont Borgyogyaszati es Allergologiai Klinika
  • Allergo-Derm Bakos Kft.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

10 mg of PF-04965842 QD

30 mg of PF-04965842 QD

100 mg of PF-04965842 QD

200 mg of PF-04965842 QD

placebo QD

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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).
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.
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).
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Time to Achieving >=3 Points Improvement in NRS
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Time 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).
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).
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).
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.
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.
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.
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%.
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.
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.
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.
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 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.
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
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.
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.
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.
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.

Full Information

First Posted
April 11, 2016
Last Updated
April 17, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02780167
Brief Title
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
Official Title
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOSE-RANGING, STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-04965842 IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Phase 2, randomized, double-blind, placebo, atopic dermatitis, safety, efficacy, JAK, janus kinase, moderate, severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
10 mg of PF-04965842 QD
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
30 mg of PF-04965842 QD
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
100 mg of PF-04965842 QD
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
200 mg of PF-04965842 QD
Arm Title
Cohort 5
Arm Type
Placebo Comparator
Arm Description
placebo QD
Intervention Type
Drug
Intervention Name(s)
PF-04965842
Intervention Description
10 mg of PF-04965842 QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04965842
Intervention Description
30 mg of PF-04965842 QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04965842
Intervention Description
100 mg of PF-04965842 QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04965842
Intervention Description
200 mg of PF-04965842 QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo QD for 12 weeks
Primary Outcome Measure Information:
Title
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
Description
The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12
Description
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time Frame
Baseline and Week 12
Title
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
Description
The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time Frame
Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.
Title
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Description
The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Description
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time Frame
Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16
Title
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Description
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Time Frame
Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Title
Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Description
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Time Frame
Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Title
Time to Achieving >=3 Points Improvement in NRS
Description
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Time Frame
Baseline till Week 16
Title
Time to Achieving >=4 Points Improvement in NRS
Description
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Time Frame
Baseline till Week 16
Title
Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Description
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Time Frame
Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Title
Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Description
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
Time Frame
Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Title
Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Description
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time Frame
All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Description
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time Frame
All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Description
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
Time Frame
All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Change From Baseline in Affected BSA at All Scheduled Time Points
Description
BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
Description
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Percent Change From Baseline in SCORAD at All Scheduled Time Points
Description
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
Description
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
Description
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Title
Number of Participants With Treatment-emergent Adverse Events (AEs)
Description
An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Baseline till Week 16
Title
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
Time Frame
Baseline up to Week 16
Title
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
Description
The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Description
The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Title
Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Description
The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Title
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Description
The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Time Frame
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit. Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits). Exclusion Criteria: History of human immunodeficiency virus (HIV) or positive HIV serology at screening, Infected with hepatitis B or hepatitis C viruses. Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) Have received any of the following treatment regiments specified in the timeframes outlined below: Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine. Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor. Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Huntington Medical Foundation
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Peninsula Research Associates, Inc.
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
TCR Medical Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Connecticut Health Center (UConn Health)
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Olympian Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
North Florida Dermatology Associates, PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Park Avenue Dermatology Administration Annex
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Forward Clinical Trials, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Dundee Dermatology
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Dawes Fretzin Dermatology Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Shondra L Smith, MD Dermatology & Advanced Aesthetics
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
The Dermatology Group, P.C
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Forest Hills Dermatology Group
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
DermDox Centers for Dermatology
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
UPMC Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Virginia Clinical Research,Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
West End Dermatology Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Australian Clinical Research Network
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
North Eastern Health Specialists
City
Hectorville, South Australia
ZIP/Postal Code
5073
Country
Australia
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Research by ICLS
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Skin Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B IA5
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Windsor Clinical Research Inc
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
ISA GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Bacs Kiskun Megyei Korhaz, Bor es Nemibeteggondozo
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
CRU Hungary Ltd., MISEK-CRU
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem SzentGyorgyi Albert Klinikai Kozpont Borgyogyaszati es Allergologiai Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Allergo-Derm Bakos Kft.
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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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.
Results Reference
derived
PubMed Identifier
31577341
Citation
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. Erratum In: JAMA Dermatol. 2020 Jan 1;156(1):104.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7451006&StudyName=A+Phase+2b+Randomized%2C+Double%E2%80%91blind%2C+Placebo-controlled%2C+Parallel%2C+Multicenter%2C+Dose-ranging%2C+Study+To+Evaluate+The+Efficacy+And+Safety+Profile+Of+Pf-04965842+In+Subjects+With+Moderate+To+Severe+Atopic+Dermatitis
Description
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Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

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