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Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-2)

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 severity 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

Emmaus Research Center, Inc.
Advanced Research Center, Inc. - Los Alamitos Site
Peninsula Research Associates, Inc.
Clinical Science Institute
Asthma and Allergy Associates, PC
Colorado Springs Dermatology Clinic, PC
Olympian Clinical Research
Clinical Neuroscience Solutions, Inc.
Precision Imaging
Solutions Through Advanced Research, Inc.
Clinical Neuroscience Solutions, Inc
ForCare Clinical Research
Imaging Center of Idaho
ASR, LLC
Meridian Clinical Research
Massachusetts General Hospital
MediSearch Clinical Trials
Sadick Research Group
PMG Research of Wilmington, LLC
The Ohio State University Wexner Medical Center
The Ohio State University Dermatology East
Tanenbaum Dermatology Center
Clinical Neuroscience Solutions, Inc.
Austin Institute for Clinical Research, Inc. - Central
Center for Clinical Studies, LTD. LLP
West Houston Dermatology, PA
Summit Clinical Research, LLC
Virginia Dermatology and Skin Cancer Center
Australian Clinical Research Network
The Skin Centre
Veracity Clinical Research Pty Ltd
Skin and Cancer Foundation Inc
Sinclair Dermatology
Royal Melbourne Hospital
The Royal Children's Hospital (RCH)
Medical Centre Asklepii OOD
MHAT Dr. Tota Venkova AD
"Acibadem City Clinic MHAT Tokuda" EAD
"DCC Aleksandrovska" EOOD
Diagnostic Consultative Center Fokus-5
Medical Centre Synexus Sofia EOOD
University of British Columbia Department of Dermatology and Skin Science
Winnipeg Clinic
North York Research Inc.
Oshawa Clinic Dermatology Trials
York Dermatology Clinic and Research Centre
Research Toronto
Diex Recherche Sherbrooke Inc.
Peking University First Hospital
Beijing Friendship Hospital, Capital Medical University
The Second Affiliated Hospital of Army Medical University, PLA
The University of Hong Kong - Shenzhen Hospital
Tianjin Medical University General Hospital, Dermatological Department
Dermamedica S.R.O.
Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni
Lekarna u Stribrneho orla
Sanatorium profesora Arenbergera
Lekarna U sv. Ignace
Dermatologicka Ambulance
Lekarna na Hranicni
Fachklinik Bad Bentheim
ISA GmbH
Fachärztliche Gemeinschaftspraxis für Dermatologie und Venerologie, Allergologie,
IKF Pneumologie GmbH & Co KG
Klinische Forschung Hamburg GmbH
Universitaet Muenster
Klinische Forschung Schwerin GmbH
SE AOK Bor, Nemikortani es Boronkologiai Klinika
Budapest Főváros XIX. Kerületi Önkormányzat Kispesti Egészsegügyi Intézete
Debreceni Egyetem Klinikai Kozpont
ALLERGO-DERM BAKOS Kft.
Queen's square Medical Facilities Queen's square Dermatology and Allergology
Noguchi Dermatology Clinic
Yoshioka Dermatology Clinic
Kume Clinic
Sumire Dermatology Clinic
Matsuyama Dermatology Clinic
Hoshikuma Dermatology・Allergy Clinic
Sanrui Hifuka
Soon Chun Hyang University Bucheon Hospital
The Catholic University of Korea, Incheon St.Mary's Hospital
Inha University Hospital
Kyungpook National University Hospital
Chonnam National University Hospital
Korea University Anam Hospital
Severance Hospital, Yonsei Univ. Health System
The Catholic University of Korea, Seoul St. Mary's Hospital
Chung-Ang University Hospital
Hallym university Kangnam Sacred Heart Hospital
Selga Freiberga private practice in dermatovenerology and cosmetology
Riga 1st Hospital, Clinic for Dermatology and STD
Aesthetic dermatology clinic of Prof. J. Kisis
Health Centre 4 Ltd. Diagnostics Centre
Health Centre 4 Ltd
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
KLIMED Marek Klimkiewicz
Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o. o.
Centrum Badań Klinicznych JCI
Krakowskie Centrum Medyczne Sp. z o.o.
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
KO-MED Centra Kliniczne Lublin II
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Synexus Polska Sp. z o. o. Oddzial w Warszawie
Centrum Medyczne AMED
MTZ Clinical Research Sp. z o.o.
Klinika Ambroziak Sp. z o.o.
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Lukasz Matusiak "4HEALTH"
Plymouth Hospitals NHS Trust, Derriford Hospital
MAC Clinical Research
MAC Clinical Research Ltd
Barnsley Hospital NHS Foundation Trust
University Hospital Bristol NHS Foundation Trust
MAC Clinical Research Ltd

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 soles, palms and scalp.

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) 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 Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12

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.

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12

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.

Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) 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.

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8

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.

Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8

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

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12

Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12

EASI evaluates severity of participant's 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.

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

Change From Baseline in the Percentage Body Surface Area (%BSA) Affected 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 (%BSA) (From EASI) < 5% at Weeks 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 Achieving Scoring Atopic Dermatitis (SCORAD) Response >=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 Achieving Scoring Atopic Dermatitis (SCORAD) Response >=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 (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 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 (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 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.

Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) 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.

Full Information

NCT ID

NCT03575871

First Posted

June 15, 2018

Last Updated

April 10, 2020

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03575871

Brief Title

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

Acronym

JADE Mono-2

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

April 2020

Overall Recruitment Status

Completed

Study Start Date

June 29, 2018 (Actual)

Primary Completion Date

August 13, 2019 (Actual)

Study Completion Date

August 13, 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

B7451013 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

391 (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 Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12

Description

Time Frame

Baseline, Weeks 2, 4, 8 and 12

Title

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

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

Description

Time Frame

Baseline up to Day 15

Title

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8

Description

Time Frame

Baseline, Weeks 2, 4, and 8

Title

Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8

Description

Time Frame

Baseline, Weeks 2, 4, and 8

Title

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

Description

Time Frame

Weeks 2, 4, 8 and 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12

Description

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12

Description

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12

Description

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

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

Description

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12

Description

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 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

Weeks 2, 4, 8, and 12

Title

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

Description

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=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, Weeks 2, 4, 8, and 12

Title

Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 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, Weeks 2, 4, 8, and 12

Title

Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 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, Weeks 2, 4, 8, and 12

Title

Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) 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, Weeks 2, 4, 8, and 12

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 severity 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

Emmaus Research Center, Inc.

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

Advanced Research Center, Inc. - Los Alamitos Site

City

Los Alamitos

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

Peninsula Research Associates, Inc.

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Clinical Science Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Asthma and Allergy Associates, PC

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Colorado Springs Dermatology Clinic, PC

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80910

Country

United States

Facility Name

Olympian Clinical Research

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc.

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Precision Imaging

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Solutions Through Advanced Research, Inc.

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

ForCare Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Imaging Center of Idaho

City

Caldwell

State/Province

Idaho

ZIP/Postal Code

83605

Country

United States

Facility Name

ASR, LLC

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83687

Country

United States

Facility Name

Meridian Clinical Research

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

MediSearch Clinical Trials

City

Saint Joseph

State/Province

Missouri

ZIP/Postal Code

64506

Country

United States

Facility Name

Sadick Research Group

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

PMG Research of Wilmington, LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28411

Country

United States

Facility Name

The Ohio State University Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

The Ohio State University Dermatology East

City

Gahanna

State/Province

Ohio

ZIP/Postal Code

43230

Country

United States

Facility Name

Tanenbaum Dermatology Center

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38117

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc.

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Austin Institute for Clinical Research, Inc. - Central

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Center for Clinical Studies, LTD. LLP

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

West Houston Dermatology, PA

City

Houston

State/Province

Texas

ZIP/Postal Code

77082

Country

United States

Facility Name

Summit Clinical Research, LLC

City

Franklin

State/Province

Virginia

ZIP/Postal Code

23851

Country

United States

Facility Name

Virginia Dermatology and Skin Cancer Center

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Australian Clinical Research Network

City

Maroubra

State/Province

New South Wales

ZIP/Postal Code

2035

Country

Australia

Facility Name

The Skin Centre

City

Benowa

State/Province

Queensland

ZIP/Postal Code

4217

Country

Australia

Facility Name

Veracity Clinical Research Pty Ltd

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Skin and Cancer Foundation Inc

City

Carlton

State/Province

Victoria

Country

Australia

Facility Name

Sinclair Dermatology

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

The Royal Children's Hospital (RCH)

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Medical Centre Asklepii OOD

City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Facility Name

MHAT Dr. Tota Venkova AD

City

Gabrovo

ZIP/Postal Code

5300

Country

Bulgaria

Facility Name

"Acibadem City Clinic MHAT Tokuda" EAD

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

"DCC Aleksandrovska" EOOD

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Diagnostic Consultative Center Fokus-5

City

Sofia

ZIP/Postal Code

1463

Country

Bulgaria

Facility Name

Medical Centre Synexus Sofia EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

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

Winnipeg Clinic

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3C 0N2

Country

Canada

Facility Name

North York Research Inc.

City

North York

State/Province

Ontario

ZIP/Postal Code

M2M 4J5

Country

Canada

Facility Name

Oshawa Clinic Dermatology Trials

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1H 1B9

Country

Canada

Facility Name

York Dermatology Clinic and Research Centre

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

Diex Recherche Sherbrooke Inc.

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1L 0H8

Country

Canada

Facility Name

Peking University First Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Beijing Friendship Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

The Second Affiliated Hospital of Army Medical University, PLA

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

The University of Hong Kong - Shenzhen Hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518053

Country

China

Facility Name

Tianjin Medical University General Hospital, Dermatological Department

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Dermamedica S.R.O.

City

Nachod

ZIP/Postal Code

547 01

Country

Czechia

Facility Name

Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni

City

Nachod

ZIP/Postal Code

547 01

Country

Czechia

Facility Name

Lekarna u Stribrneho orla

City

Nachod

ZIP/Postal Code

54701

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

Dermatologicka Ambulance

City

Svitavy

ZIP/Postal Code

568 02

Country

Czechia

Facility Name

Lekarna na Hranicni

City

Svitavy

ZIP/Postal Code

56802

Country

Czechia

Facility Name

Fachklinik Bad Bentheim

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

ISA GmbH

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Fachärztliche Gemeinschaftspraxis für Dermatologie und Venerologie, Allergologie,

City

Blankenfelde-Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

IKF Pneumologie GmbH & Co KG

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Klinische Forschung Hamburg GmbH

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Universitaet Muenster

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Klinische Forschung Schwerin GmbH

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

SE AOK Bor, Nemikortani es Boronkologiai Klinika

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Budapest Főváros XIX. Kerületi Önkormányzat Kispesti Egészsegügyi Intézete

City

Budapest

ZIP/Postal Code

1195

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

ALLERGO-DERM BAKOS Kft.

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Queen's square Medical Facilities Queen's square Dermatology and Allergology

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

220-6208

Country

Japan

Facility Name

Noguchi Dermatology Clinic

City

Kamimashiki-gun

State/Province

Kumamoto

ZIP/Postal Code

861-3101

Country

Japan

Facility Name

Yoshioka Dermatology Clinic

City

Neyagawa

State/Province

Osaka

ZIP/Postal Code

572-0838

Country

Japan

Facility Name

Kume Clinic

City

Sakai

State/Province

Osaka

ZIP/Postal Code

593-8324

Country

Japan

Facility Name

Sumire Dermatology Clinic

City

Edogawa-ku

State/Province

Tokyo

ZIP/Postal Code

133-0057

Country

Japan

Facility Name

Matsuyama Dermatology Clinic

City

Nakano-ku

State/Province

Tokyo

ZIP/Postal Code

165-0026

Country

Japan

Facility Name

Hoshikuma Dermatology・Allergy Clinic

City

Fukuoka

ZIP/Postal Code

814-0171

Country

Japan

Facility Name

Sanrui Hifuka

City

Saitama

ZIP/Postal Code

330-0854

Country

Japan

Facility Name

Soon Chun Hyang University Bucheon Hospital

City

Bucheon-si

State/Province

Gyeonggi-do

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Incheon St.Mary's Hospital

City

Bupyeong-gu

State/Province

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Inha University Hospital

City

Jung-gu

State/Province

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei Univ. Health System

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Chung-Ang University Hospital

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

Hallym university Kangnam Sacred Heart Hospital

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Selga Freiberga private practice in dermatovenerology and cosmetology

City

Jelgava

ZIP/Postal Code

LV-3001

Country

Latvia

Facility Name

Riga 1st Hospital, Clinic for Dermatology and STD

City

Riga

ZIP/Postal Code

LV-1001

Country

Latvia

Facility Name

Aesthetic dermatology clinic of Prof. J. Kisis

City

Riga

ZIP/Postal Code

LV-1003

Country

Latvia

Facility Name

Health Centre 4 Ltd. Diagnostics Centre

City

Riga

ZIP/Postal Code

LV-1003

Country

Latvia

Facility Name

Health Centre 4 Ltd

City

Riga

ZIP/Postal Code

LV-1013

Country

Latvia

Facility Name

NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.

City

Bialystok

ZIP/Postal Code

15-453

Country

Poland

Facility Name

KLIMED Marek Klimkiewicz

City

Białystok

ZIP/Postal Code

15-704

Country

Poland

Facility Name

Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o. o.

City

Krakow

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Centrum Badań Klinicznych JCI

City

Kraków

ZIP/Postal Code

30-348

Country

Poland

Facility Name

Krakowskie Centrum Medyczne Sp. z o.o.

City

Kraków

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

KO-MED Centra Kliniczne Lublin II

City

Lublin

ZIP/Postal Code

20-362

Country

Poland

Facility Name

Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.

City

Poznan

ZIP/Postal Code

60-848

Country

Poland

Facility Name

Twoja Przychodnia - Szczecinskie Centrum Medyczne

City

Szczecin

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Synexus Polska Sp. z o. o. Oddzial w Warszawie

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Centrum Medyczne AMED

City

Warszawa

ZIP/Postal Code

01-518

Country

Poland

Facility Name

MTZ Clinical Research Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

Klinika Ambroziak Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-758

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

City

Wroclaw

ZIP/Postal Code

50-381

Country

Poland

Facility Name

Lukasz Matusiak "4HEALTH"

City

Wrocław

ZIP/Postal Code

50-566

Country

Poland

Facility Name

Plymouth Hospitals NHS Trust, Derriford Hospital

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

MAC Clinical Research

City

Blackpool

State/Province

Lancashire

ZIP/Postal Code

FY2 0JH

Country

United Kingdom

Facility Name

MAC Clinical Research Ltd

City

Cannock

State/Province

South Staffordshire

ZIP/Postal Code

WS11 0BN

Country

United Kingdom

Facility Name

Barnsley Hospital NHS Foundation Trust

City

Barnsley

State/Province

South Yorkshire

ZIP/Postal Code

S75 2EP

Country

United Kingdom

Facility Name

University Hospital Bristol NHS Foundation Trust

City

Bristol

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

MAC Clinical Research Ltd

City

Manchester

ZIP/Postal Code

M13 9NQ

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

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Results Reference

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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

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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.

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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

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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.

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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

32492087

Citation

Silverberg JI, Simpson EL, Thyssen JP, Gooderham M, Chan G, Feeney C, Biswas P, Valdez H, DiBonaventura M, Nduaka C, Rojo R. Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Aug 1;156(8):863-873. doi: 10.1001/jamadermatol.2020.1406.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=B7451013

Description

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Learn more about this trial

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

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