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

• ClinicalTrials.gov Identifier: NCT02780167
• Recruitment Status: Completed
• First Posted: May 23, 2016
• Results First Posted: May 16, 2018
• Last Update Posted: May 2, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: PF-04965842; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 269 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: April 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1; 10 mg of PF-04965842 QD	Drug: PF-04965842; 10 mg of PF-04965842 QD for 12 weeks
Experimental: Cohort 2; 30 mg of PF-04965842 QD	Drug: PF-04965842; 30 mg of PF-04965842 QD for 12 weeks
Experimental: Cohort 3; 100 mg of PF-04965842 QD	Drug: PF-04965842; 100 mg of PF-04965842 QD for 12 weeks
Experimental: Cohort 4; 200 mg of PF-04965842 QD	Drug: PF-04965842; 200 mg of PF-04965842 QD for 12 weeks
Placebo Comparator: Cohort 5; placebo QD	Drug: Placebo; Placebo QD for 12 weeks

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: Baseline and Week 12 ]
   The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).

Secondary Outcome Measures :

1. Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 [ Time Frame: Baseline and Week 12 ]
   The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
2. 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 [ Time Frame: Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16. ]
   The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
3. Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points [ Time Frame: Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16 ]
   The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
4. Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. [ Time Frame: Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16 ]
   The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
5. Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points [ 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 ]

   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).

6. Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points [ 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 ]

   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).

7. Time to Achieving >=3 Points Improvement in NRS [ Time Frame: Baseline till Week 16 ]

   The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).

   The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).

8. Time to Achieving >=4 Points Improvement in NRS [ Time Frame: Baseline till Week 16 ]

   The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).

   The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).

9. Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points [ 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 ]

   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).

10. Change From Baseline in Pruritus NRS Score at All Scheduled Time Points [ 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 ]

    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).

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

  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.

Contacts and Locations

Locations

United States, Alabama

Clinical Research Center of Alabama

Birmingham, Alabama, United States, 35209

United States, California

California Dermatology & Clinical Research Institute

Encinitas, California, United States, 92024

Huntington Medical Foundation

Pasadena, California, United States, 91105

Peninsula Research Associates, Inc.

Rolling Hills Estates, California, United States, 90274

Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery

Sacramento, California, United States, 95819

TCR Medical Corporation

San Diego, California, United States, 92123

Clinical Science Institute

Santa Monica, California, United States, 90404

United States, Connecticut

University of Connecticut Health Center (UConn Health)

Farmington, Connecticut, United States, 06032

United States, Florida

Olympian Clinical Research

Clearwater, Florida, United States, 33756

North Florida Dermatology Associates, PA

Jacksonville, Florida, United States, 32204

Park Avenue Dermatology Administration Annex

Orange Park, Florida, United States, 32073

Park Avenue Dermatology

Orange Park, Florida, United States, 32073

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida, United States, 32174

Forward Clinical Trials, Inc.

Tampa, Florida, United States, 33624

United States, Georgia

MedaPhase, Inc.

Newnan, Georgia, United States, 30263

United States, Illinois

Dundee Dermatology

West Dundee, Illinois, United States, 60118

United States, Indiana

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46256

Dawes Fretzin Dermatology Group, LLC

Indianapolis, Indiana, United States, 46256

The Indiana Clinical Trials Center

Plainfield, Indiana, United States, 46168

United States, Kentucky

DS Research

Louisville, Kentucky, United States, 40241

United States, Louisiana

Shondra L Smith, MD Dermatology & Advanced Aesthetics

Lake Charles, Louisiana, United States, 70605

United States, Michigan

Somerset Skin Centre

Troy, Michigan, United States, 48084

United States, Missouri

MediSearch Clinical Trials

Saint Joseph, Missouri, United States, 64506

United States, Nevada

Clinical Research Consortium

Las Vegas, Nevada, United States, 89119

United States, New Jersey

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States, 08520

The Dermatology Group, P.C

Verona, New Jersey, United States, 07044

United States, New York

Forest Hills Dermatology Group

Forest Hills, New York, United States, 11375

Sadick Research Group

New York, New York, United States, 10075

United States, Oklahoma

Vital Prospects Clinical Research Institute, P.C

Tulsa, Oklahoma, United States, 74136

United States, Pennsylvania

DermDox Centers for Dermatology

Hazleton, Pennsylvania, United States, 18201

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, United States, 15213

United States, Rhode Island

Clinical Partners, LLC

Johnston, Rhode Island, United States, 02919

United States, South Dakota

Health Concepts

Rapid City, South Dakota, United States, 57702

United States, Texas

Bellaire Dermatology Associates

Bellaire, Texas, United States, 77401

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

United States, Virginia

Virginia Clinical Research,Inc

Norfolk, Virginia, United States, 23502

West End Dermatology Associates

Richmond, Virginia, United States, 23233

Australia, Australian Capital Territory

Woden Dermatology

Phillip, Australian Capital Territory, Australia, 2606

Australia, New South Wales

Australian Clinical Research Network

Sydney, New South Wales, Australia, 2035

Australia, Queensland

The Skin Centre

Benowa, Queensland, Australia, 4217

Veracity Clinical Research

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Sinclair Dermatology

East Melbourne, Victoria, Australia, 3002

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Australia, Western Australia

Fremantle Dermatology

Fremantle, Western Australia, Australia, 6160

Australia

North Eastern Health Specialists

Hectorville, South Australia, Australia, 5073

Canada, British Columbia

University of British Columbia

Vancouver, British Columbia, Canada, V5Z 4E8

Canada, Manitoba

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada, R3M 3Z4

Canada, Ontario

Lynderm Research Inc.

Markham, Ontario, Canada, L3P 1X2

Research by ICLS

Oakville, Ontario, Canada, L6J 7W5

Skin Centre for Dermatology

Peterborough, Ontario, Canada, K9J 5K2

The Centre for Dermatology

Richmond Hill, Ontario, Canada, L4B IA5

K. Papp Clinical Research

Waterloo, Ontario, Canada, N2J 1C4

Windsor Clinical Research Inc

Windsor, Ontario, Canada, N8W 5L7

Canada, Quebec

Innovaderm Research Inc.

Montreal, Quebec, Canada, H2K 4L5

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada, J1H 1Z1

Canada

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

Quebec, Canada, G1V 4X7

Germany

ISA GmbH

Berlin, Germany, 10789

Universitaetsklinikum Schleswig-Holstein

Luebeck, Germany, 23538

Universitaetsklinikum Muenster

Muenster, Germany, 48149

Universitaetsklinikum Tuebingen

Tuebingen, Germany, 72076

Hungary

Bacs Kiskun Megyei Korhaz, Bor es Nemibeteggondozo

Kecskemet, Hungary, 6000

CRU Hungary Ltd., MISEK-CRU

Miskolc, Hungary, 3529

Szegedi Tudomanyegyetem SzentGyorgyi Albert Klinikai Kozpont Borgyogyaszati es Allergologiai Klinika

Szeged, Hungary, 6720

Allergo-Derm Bakos Kft.

Szolnok, Hungary, 5000

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Statistical Analysis Plan  [PDF] May 9, 2017

Study Protocol  [PDF] December 22, 2015

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 Jan 21. doi: 10.1007/s40262-021-01104-z. [Epub ahead of print] Erratum in: Clin Pharmacokinet. 2022 Feb 18;:.

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. Erratum in: Am J Clin Dermatol. 2021 Nov;22(6):905.

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• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02780167
• Other Study ID Numbers: B7451006; 2015-005513-72 ( EudraCT Number )
• First Posted: May 23, 2016
• Results First Posted: May 16, 2018
• Last Update Posted: May 2, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:

Phase 2; randomized; double-blind; placebo; atopic dermatitis; safety; efficacy; JAK; janus kinase; moderate; severe

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Abrocitinib; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action