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Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-1)

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PF-04965842 100 mg

PF-04965842 200 mg

Placebo

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

12 years of age or older with a minimum body weight of 40 kg
Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)
Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Prior treatment with JAK inhibitors
Other active nonAD inflammatory skin diseases or conditions affecting skin
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Sites / Locations

Clinical Research Center of Alabama, LLC
California Dermatology & Clinical Research Institute
Rady Children's Hospital - San Diego/University of California, San Diego
TCR Medical Corporation
Clinical Science Institute
Florida Academic Centers Research and Education, LLC
Olympian Clinical Research
Forward Clinical Trials, Inc.
Meridian Clinical Research, LLC
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Dawes Fretzin Clinical Research Group, LLC
Dawes Fretzin Dermatology Group, LLC
Tufts Medical Center
Henry Ford Medical Center, New Center One
Somerset Skin Centre
MediSearch Clinical Trials
Lynn Health Science Institute
Vital Prospects Clinical Research Institute, P.C.
Oregon Health & Science University
Medical University of South Carolina Investigational Drug Services
MUSC SCTR Research Nexus Clinic and Laboratory
Arlington Research Center, Inc.
The University of Texas Health Science Center Houston
Texas Dermatology and Laser Specialists
Virginia Clinical Research, Inc.
Pace Dermatology Associates
MultiCare Allenmore Hospital
MultiCare Institute for Research and Innovation
Pace Dermatology Associates
Australian Clinical Research Network (ACRN)
Spectrum Medical Imaging
Queensland X-Ray
Veracity Clinical Research Pty Ltd
Emeritus Research
Skin and Cancer Foundation Inc
Melbourne Radiology Clinic
Sinclair Dermatology
The Royal Children's Hospital
Bridge Road Imaging
Kirk Barber Research
Institute for Skin Advancement
Dr. Chih-ho Hong Medical Inc
University of British Columbia Department of Dermatology and Skin Science
Wiseman Dermatology Research Inc.
Lynderm Research Inc
SKiN Centre for Dermatology
The Centre for Dermatology
York Dermatology Center
Research Toronto
Innovaderm Research Inc.
Diex Research Sherbrooke Inc.
Lekarna Na Vaclavskem namesti
Kozni ambulance Kutna Hora, s.r.o.
Lekarna Fakultni Nemocnice Ostrava
Fakultni Nemocnice Ostrava, Kozni oddeleni
Sanatorium profesora Arenbergera
Lekarna U sv. Ignace
Krajska zdravotni a.s.,Masarykova nemocnice o.z.
Lekarna Masarykovy nemocnice v Usti nad Labem, o.z.
Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
Fachklinik Bad Bentheim
Charité - Universitaetsmedizin Berlin, CCM
ISA - Interdisciplinary Study Association GmbH
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Universitätsklinikum Erlangen, Hautklinik
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Ludwig-Maximilians-University Munich
Universitätsklinikum Münster
Klinische Forschung Schwerin GmbH
Bács-Kiskun Megyei Kórház, Bőr-és nemibeteg Szakrendelés
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Bacs-Kiskun Megyei Korhaz Kozponti Radiologiai Osztaly
CRU Hungary Ltd.
Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-,Nemikortani es Onkodermatologiai Klinika
Pecsi Tudomanyegyetem Klinikai Kozpont
MULTIKLINIKA Salute Sp. z o.o.
Silmedic Sp. z o.o., Oddzial w Katowicach
Centrum Medyczne Angelius Provita
Pro Familia Altera Sp. z o.o.
NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
Dermedic Jacek Zdybski
Wojskowy Instytut Medyczny, Klinika Dermatologiczna
Derriford Hospital, Plymouth Hospitals NHS Trust
Royal Free London NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Children's Hospital NHS Foundation Trust
The Dudley Group NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-04965842 100 mg

PF-04965842 200 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12

IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12

EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Secondary Outcome Measures

Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS)

Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.

Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS)

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set

PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set

Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus

Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. 95% CI was based on the Brookmeyer and Crowley method.

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8

Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8

Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12

Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12

Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12

Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12

4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.

Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12

4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.

Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.

Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12

DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12

CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12

Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12

Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12

Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12

Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.

Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12

Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12

Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12

POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) 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, where higher score indicated greater severity.

Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12

Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.

Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12

Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12

EQ-5D-5L: standardized participant (aged >17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.

Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12

EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's (aged above 17 years) rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.

Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12

EQ-5D-Y: standardized participant (aged 12-17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. UK value sets (with all possible health states) was used for adolescents in the study, range from 1 to -0.594. Higher (positive) scores = better health state.

Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12

EQ-5D-Y is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score specifically developed and validated for use by youths age 12-17 years. EQ-5D-Y consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12

FACIT-F is a 13-item questionnaire. Participants (aged above 17 years) scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Higher the participant's response to the questions (with the exception of 2 negatively stated) greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).

Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12

Peds-FACIT-F is a 13-item questionnaire for adolescents of 12-17 years of age. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Higher the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the Peds-FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).

Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary

SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Physical component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.

Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary

SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.

Plasma Concentration Versus Time Summary of PF-04965842

Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.

Full Information

NCT ID

NCT03349060

First Posted

November 17, 2017

Last Updated

November 20, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03349060

Brief Title

Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

Acronym

JADE Mono-1

Official Title

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

December 7, 2017 (Actual)

Primary Completion Date

March 26, 2019 (Actual)

Study Completion Date

March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

387 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-04965842 100 mg

Arm Type

Experimental

Arm Title

PF-04965842 200 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-04965842 100 mg

Intervention Description

PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

PF-04965842 200 mg

Intervention Description

PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo, administered as two tablets to be taken orally once daily for 12 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12

Description

Time Frame

Baseline, Week 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS)

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS)

Description

Time Frame

Baseline, Week 2, 4, 12

Title

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set

Description

Time Frame

Baseline, Week 12

Title

Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus

Description

Time Frame

Baseline up to Week 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8

Description

Time Frame

Baseline, Week 2, 4, 8

Title

Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8

Description

Time Frame

Baseline, Week 2, 4, 8

Title

Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12

Description

Time Frame

Week 2, 4, 8, 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12

Description

4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.

Time Frame

Week 2, 4, 8, 12

Title

Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12

Description

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12

Description

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12

Description

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12

Description

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12

Description

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12

Description

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 2, 4, 8, 12

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary

Description

SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.

Time Frame

Baseline, Week 12

Title

Plasma Concentration Versus Time Summary of PF-04965842

Description

Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.

Time Frame

Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 12 years of age or older with a minimum body weight of 40 kg Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4) Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control Exclusion Criteria: Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study Prior treatment with JAK inhibitors Other active nonAD inflammatory skin diseases or conditions affecting skin Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

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, LLC

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

Rady Children's Hospital - San Diego/University of California, San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92123

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

Florida Academic Centers Research and Education, LLC

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Olympian Clinical Research

City

Largo

State/Province

Florida

ZIP/Postal Code

33770

Country

United States

Facility Name

Forward Clinical Trials, Inc.

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

NorthShore University HealthSystem Dermatology Clinical Trials Unit

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

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

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Henry Ford Medical Center, New Center One

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

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

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

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

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Medical University of South Carolina Investigational Drug Services

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

MUSC SCTR Research Nexus Clinic and Laboratory

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Arlington Research Center, Inc.

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

The University of Texas Health Science Center Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

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

Pace Dermatology Associates

City

Lakewood

State/Province

Washington

ZIP/Postal Code

98499

Country

United States

Facility Name

MultiCare Allenmore Hospital

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

MultiCare Institute for Research and Innovation

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Pace Dermatology Associates

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Australian Clinical Research Network (ACRN)

City

Maroubra

State/Province

New South Wales

ZIP/Postal Code

2035

Country

Australia

Facility Name

Spectrum Medical Imaging

City

Maroubra

State/Province

New South Wales

ZIP/Postal Code

2035

Country

Australia

Facility Name

Queensland X-Ray

City

Upper Mount Gravatt

State/Province

Queensland

ZIP/Postal Code

4122

Country

Australia

Facility Name

Veracity Clinical Research Pty Ltd

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Emeritus Research

City

Camberwell

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

Facility Name

Skin and Cancer Foundation Inc

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Melbourne Radiology Clinic

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Sinclair Dermatology

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

The Royal Children's Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Bridge Road Imaging

City

Richmond

State/Province

Victoria

ZIP/Postal Code

3121

Country

Australia

Facility Name

Kirk Barber Research

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Institute for Skin Advancement

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3A 2N1

Country

Canada

Facility Name

Dr. Chih-ho Hong Medical Inc

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

University of British Columbia Department of Dermatology and Skin Science

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

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 1A5

Country

Canada

Facility Name

York Dermatology Center

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4C 9M7

Country

Canada

Facility Name

Research Toronto

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4W 2N2

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

J1L 0H8

Country

Canada

Facility Name

Lekarna Na Vaclavskem namesti

City

Kutna Hora

ZIP/Postal Code

284 01

Country

Czechia

Facility Name

Kozni ambulance Kutna Hora, s.r.o.

City

Kutna Hora

ZIP/Postal Code

28401

Country

Czechia

Facility Name

Lekarna Fakultni Nemocnice Ostrava

City

Ostrava - Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Fakultni Nemocnice Ostrava, Kozni oddeleni

City

Ostrava - Poruba

ZIP/Postal Code

70852

Country

Czechia

Facility Name

Sanatorium profesora Arenbergera

City

Praha 1

ZIP/Postal Code

11000

Country

Czechia

Facility Name

Lekarna U sv. Ignace

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Krajska zdravotni a.s.,Masarykova nemocnice o.z.

City

Usti nad Labem

ZIP/Postal Code

40113

Country

Czechia

Facility Name

Lekarna Masarykovy nemocnice v Usti nad Labem, o.z.

City

Usti nad Labem

ZIP/Postal Code

40113

Country

Czechia

Facility Name

Universitaetsklinikum Schleswig-Holstein/Campus Luebeck

City

Luebeck

State/Province

Schleswig-holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

Fachklinik Bad Bentheim

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Charité - Universitaetsmedizin Berlin, CCM

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

ISA - Interdisciplinary Study Association GmbH

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitätsklinikum Erlangen, Hautklinik

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Ludwig-Maximilians-University Munich

City

Munich

ZIP/Postal Code

80337

Country

Germany

Facility Name

Universitätsklinikum Münster

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Klinische Forschung Schwerin GmbH

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Bács-Kiskun Megyei Kórház, Bőr-és nemibeteg Szakrendelés

City

Kecskemet

State/Province

Bács-kiskun

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Bacs-Kiskun Megyei Korhaz Kozponti Radiologiai Osztaly

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

CRU Hungary Ltd.

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-,Nemikortani es Onkodermatologiai Klinika

City

Pecs

ZIP/Postal Code

7632

Country

Hungary

Facility Name

Pecsi Tudomanyegyetem Klinikai Kozpont

City

Pecs

ZIP/Postal Code

7632

Country

Hungary

Facility Name

MULTIKLINIKA Salute Sp. z o.o.

City

Katowice

ZIP/Postal Code

40-123

Country

Poland

Facility Name

Silmedic Sp. z o.o., Oddzial w Katowicach

City

Katowice

ZIP/Postal Code

40-282

Country

Poland

Facility Name

Centrum Medyczne Angelius Provita

City

Katowice

ZIP/Postal Code

40-611

Country

Poland

Facility Name

Pro Familia Altera Sp. z o.o.

City

Katowice

ZIP/Postal Code

40-648

Country

Poland

Facility Name

NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak

City

Lodz

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Dermedic Jacek Zdybski

City

Ostrowiec Swietokrzyski

ZIP/Postal Code

27-400

Country

Poland

Facility Name

Wojskowy Instytut Medyczny, Klinika Dermatologiczna

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Derriford Hospital, Plymouth Hospitals NHS Trust

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Royal Free London NHS Foundation Trust

City

London

State/Province

Greater London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Sheffield Teaching Hospitals NHS Foundation Trust

City

Sheffield

State/Province

South Yorkshire, England

ZIP/Postal Code

S5 7AU

Country

United Kingdom

Facility Name

Sheffield Children's Hospital NHS Foundation Trust

City

Sheffield

State/Province

South Yorkshire

ZIP/Postal Code

S10 2TH

Country

United Kingdom

Facility Name

The Dudley Group NHS Foundation Trust

City

Dudley

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

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

Citations:

PubMed Identifier

35763326

Citation

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.

Results Reference

derived

PubMed Identifier

35462428

Citation

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.

Results Reference

derived

PubMed Identifier

35342978

Citation

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.

Results Reference

derived

PubMed Identifier

35061234

Citation

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. Erratum In: Clin Pharmacokinet. 2022 Apr;61(4):591.

Results Reference

derived

PubMed Identifier

34743361

Citation

Cork MJ, McMichael A, Teng J, Valdez H, Rojo R, Chan G, Zhang F, Myers DE, DiBonaventura M. Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):422-433. doi: 10.1111/jdv.17792. Epub 2021 Dec 4.

Results Reference

derived

PubMed Identifier

34406619

Citation

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.

Results Reference

derived

PubMed Identifier

33954933

Citation

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. Erratum In: Am J Clin Dermatol. 2021 Sep;22(5):739.

Results Reference

derived

PubMed Identifier

32711801

Citation

Simpson EL, Sinclair R, Forman S, Wollenberg A, Aschoff R, Cork M, Bieber T, Thyssen JP, Yosipovitch G, Flohr C, Magnolo N, Maari C, Feeney C, Biswas P, Tatulych S, Valdez H, Rojo R. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020 Jul 25;396(10246):255-266. doi: 10.1016/S0140-6736(20)30732-7.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=B7451012

Description

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

Learn more about this trial

Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

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