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Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy (JADE Compare)

Primary Purpose

Dermatitis, Dermatitis, Atopic, Eczema

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PF-04965842 100 mg

PF-04965842 200 mg

Dupilumab

Oral Placebo

Injectable Placebo

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Male or female subjects aged 18 years or older at the time of informed consent
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)
Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study
Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
2. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure; or
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.

-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study

Exclusion Criteria:

Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
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
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Other active nonAD inflammatory skin diseases or conditions affecting skin
Prior treatment with JAK inhibitors
Previous treatment with dupilumab
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

Sites / Locations

Clinical Research Center of Alabama, LLC
The University Of Alabama At Birmingham
Marvel Research, LLC
Alliance Research Centers
Allergy & Asthma Care Center of Southern California
Allergy & Asthma Associates of Southern California dba Southern California Research
Dermatology Specialists, Inc.
MedDerm Associates
Clinical Science Institute
Synexus Clinical Research US, Inc.
IMMUNOe Research Centers
Renaissance Research and Medical Group, Inc
C & R Research Services USA, Inc
Florida Academic Centers Research and Education, LLC
Moonshine Research Center, Inc.
Solutions Through Advanced Research, Inc.
Olympian Clinical Research
Wellness Clinical Research, LLC
Savin Medical Group LLC
ForCare Clinical Research
Research Institute of Southeast, LLC
Research Institute of the Southeast, LLC
Columbus Regional Research Institute
Idaho Allergy and Research
ASR, LLC
Great Lakes Clinical Trials
Midwest Allergy Sinus Asthma, SC
NorthShore University HealthSystem
Southern Illinois University School of Medicine
Dundee Dermatology
The Indiana Clinical Trials Center
Forefront Dermatology, S.C.
Meridian Clinical Research, LLC
Clinical Research Institute, Inc.
Skin Laser and Surgery Specialists of NY and NJ
Forest Hills Dermatology Group
Juva Skin and Laser Center
TrialSpark, Inc (Russell Cohen)
Cary Dermatology Center, PA
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Medication Management, LLC
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
Winston-Salem Dermatology and Surgery Center, PLLC
University Hospitals Cleveland Medical Center
Newton Clinical Research
Vital Prospects Clinical Research Institute, P.C.
Portland Clinical Research dba Columbia Allergy & Asthma Clinic
Crisor, LLC
Oregon Health & Science University (OHSU)
Paddington Testing Co, Inc.
Synexus Clinical Research US, Inc.
Synexus Clinical Research US. Inc.
Health Concepts
Arlington Research Center, Inc.
Austin Institute for Clinical Research, Inc.
Center for Clinical Studies, LTD. LLP
Center for Clinical Studies, LTD. LLP
Jordan Valley Dermatology Center
Virginia Dermatology and Skin Cancer Center
Velocity Urgent Care
Woden Dermatology
Australian Clinical Research Network
The Skin Centre
Veracity Clinical Research Pty Ltd
North Eastern Health Specialists
Box Hill Hospital
Emeritus Research
Skin and Cancer Foundation Inc
Sinclair Dermatology
Royal Melbourne Hospital
DCC 2/Sofia EOOD
"DCC Aleksandrovska" EOOD
Dermatology Clinic "Sofia" Ltd
"Mc Synexus Sofia" Eood
Medical Centre Synexus Sofia EOOD-branch Stara Zagora
"DCC "Mladost-M Varna" OOD
Pacific Dermaesthetics Inc.
Wiseman Dermatology Research Inc.
DermEffects
Lynderm Research Inc.
North Bay Dermatology Centre
SKiN Centre for Dermatology
Toronto Research Centre
AvantDerm Clinical Research
Manna Research (Toronto)
Innovaderm Research Inc.
Dr. Rachel Asiniwasis Medical Prof Corp
Centro Medico SkinMed Limitada
Clinica Dermacross S.A.
Centro Internacional de Estudios Clinicos - CIEC
MIRES (M y F Estudios Clínicos Limitada)
Dermamedica S.R.O.
CCR Ostrava, s.r.o.
BENU Lekarna
CCR Czech, a.s.
Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie
Sanatorium profesora Arenbergera
Lekarna U sv. Ignace
Synexus Czech, s.r.o.
CCR Prague, s.r.o.
Licca Clinical Research Institute
Fachklinik Bad Bentheim
Klinikum Bielefeld Rosenhohe
Universitätsklinikum Bonn AöR
Klinische Forschung Dresden GmbH
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung
Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Studienzentrum Dr. med. Beate Schwarz
SIBAmed Studienzentrum GmbH & Co KG
Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling
Universitätsklinikum Marburg
University of Muenster
SE AOK Bor-, Nemikortani es Boronkologiai Klinika
Debreceni Egyetem Klinikai Kozpont
Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS
Trial Pharma Kft.
Medmare Bt
Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
AOU Policlinico di Modena, Struttura Complessa di Dermatologia
Kawashima Dermatology Clinic
Takagi Dermatological Clinic
Dermatology Shimizu Clinic
Noguchi Dermatology Clinic
Osaka Habikino Medical Center
Kume Clinic
Iidabashi Skin Clinic
Fukuwa Clinic
Tokyo Medical University Hospital
Hoshikuma Dermatology・Allergy Clinic
Matsuda Tomoko Dermatological Clinic
Sanrui Hifuka
Korea University Ansan Hospital
Soon Chun Hyang University Bucheon Hospital
Chungnam National University Hospital CNUH
The Catholic University of Korea, Incheon St. Mary's Hospital
Severance Hospital, Yonsei Univ. Health System
Chung-Ang University Hospital
Hallym University Kangnam Sacred Heart Hospital
Riga 1st Hospital, Clinic for Dermatology and STD
Aesthetic dermatology clinic of Prof. J. Kisis
Childrens Clinical University Hospital State SLLC
Health and aesthetics Ltd
Outpatient Clinic of Ventspils
Cryptex Investigación Clínica, S.A. de C.V.
Arke Estudios Clinicos S.A. de C.V.
Eukarya Pharmasite S.C.
SMIQ. S. de R. L. de C.V.
NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL"
Centrum Medyczne SENSEMED
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
COPERNICUS-SZPITAL Oddzial Dermatologii
Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
Synexus Polska Sp. z o.o. Oddzial w Gdyni
MCBK
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Care Clinic Centrum Medyczne
Centrum Medyczne Angelius Provita
Gabinet Dermatologiczny Beata Krecisz
Centrum Medyczne Plejady
AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc
Krakowskie Centrum Medyczne Sp. z o.o.
Centrum Medyczne Promed
Prywatna Praktyka Lekarska - Adam Smialowski
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
Salve Medica Sp. z o.o. Sp. k.
KO-MED Centra Kliniczne Lublin II
NZOZ "Med-Laser" Borzecki Spolka Jawna
Dermedic Jacek Zdybski
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
LIFT-MED Spolka Akcyjna
Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii
EMED Centrum Uslug Medycznych Ewa Smialek
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Medycyna Kliniczna
Synexus Polska Sp. z o.o. Oddzial w Warszawie
MTZ Clinical Research Sp. z o.o.
RCMed Oddzial Warszawa
Carpe Diem Centrum Medycyny Estetycznej
"REUMATIKA - Centrum Reumatologii" NZOZ
Klinika Ambroziak Sp. z o.o.
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Lukasz Matusiak "4Health"
Centrum Medyczne Oporow
SUMMIT CLINICAL RESEARCH, s.r.o.
Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica
Pedi-Derma s.r.o.
Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika
SANARE spol. s.r.o., Dermatovenerologicka ambulancia
Hospital Universitari Germans Trias i Pujol
Hospital Universitari Germans Trias i Pujol
Hospital Universitario Fundacion Alcorcon
Hospital Universitario Puerta de Hierro de Majadahonda
Hospital Universitario 12 de Octubre
Hospital Universitario y Politecnico La Fe
Taipei Veterans General Hospital
Chung Shan Medical University Hospital (CSMUH)
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
National Taiwan University Hospital
Mackay Memorial Hospital
Medinova Research -West London Dedicated Research Centre
Derriford Hospital
Medinova Research, East London Dedicated Research Centre
Guy's Hospital-Guy's and St Thomas NHS Foundation Trust
Medinova Research, South London Clinical Trial Centre
MeDiNova Research North London Dedicated Research Centre
Medinova Research
Medinova Research, Warwickshire Dedicated Research Centre
Medinova, Yorkshire Quality Research Site
MeDiNova Northamptonshire Dedicated Research Centre
West Glasgow ACH, NHS Greater Glasgow and Clyde

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg

PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg

Dupilumab Injection + Oral Placebo followed by Oral Placebo

Oral Placebo + Placebo Inj followed by 100 mg PF-04965842

Oral Placebo + Placebo Inj followed by 200 mg PF-04965842

Arm Description

Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20

Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20

Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20

Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20

Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20

Outcomes

Primary Outcome Measures

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

IGA assessed severity of atopic dermatitis (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 scalp, palms and sole.

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

EASI evaluates severity of participants with 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 in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16

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 Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16

IGA assessed 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 EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16

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 EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16

EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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 EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16

Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16

Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS

Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16

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 BSA at Week 18 and 20

Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16

Participant responded to the following question: "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.

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16

DLQI is a 10-item questionnaire that measures the impact of skin disease. 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.

DLQI at Week 20

Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16

EQ-5D-5L: standardized participant 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 EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16

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 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.

EQ-5D-5L- Index Value at Week 20

EQ-5D-5L- VAS Score at Week 20

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, 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.

Change From Baseline in HADS - Depression Scale at Week 12 and 16

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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.

HADS - Anxiety Scale at Week 20

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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.

HADS - Depression Scale at Week 20

Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16

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 following: "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.

POEM at Week 20

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16

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.

PSAAD Total Score at Week 18 and 20

Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16

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 SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16

Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16

SCORAD VAS of Itch and Sleep Loss at Week 18 and 20

Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16

Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure.

Full Information

NCT ID

NCT03720470

First Posted

October 24, 2018

Last Updated

December 21, 2020

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03720470

Brief Title

Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Acronym

JADE Compare

Official Title

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

October 29, 2018 (Actual)

Primary Completion Date

December 27, 2019 (Actual)

Study Completion Date

March 6, 2020 (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

B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy 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. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.

6. Conditions and Keywords

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

Dermatitis, Dermatitis, Atopic, Eczema, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases

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

838 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg

Arm Type

Experimental

Arm Description

Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20

Arm Title

PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg

Arm Type

Experimental

Arm Description

Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20

Arm Title

Dupilumab Injection + Oral Placebo followed by Oral Placebo

Arm Type

Active Comparator

Arm Description

Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20

Arm Title

Oral Placebo + Placebo Inj followed by 100 mg PF-04965842

Arm Type

Placebo Comparator

Arm Description

Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20

Arm Title

Oral Placebo + Placebo Inj followed by 200 mg PF-04965842

Arm Type

Placebo Comparator

Arm Description

Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20

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 as follows: In the arm "PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; In the arm "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" subjects take PF-04965842 100 mg from Week 16 to Week 20.

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 as follows: In the arm "PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; In the arm "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842" subjects take PF-04965842 200 mg from Week 16 to Week 20.

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Intervention Description

Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.

Intervention Type

Drug

Intervention Name(s)

Oral Placebo

Intervention Description

Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20; In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16.

Intervention Type

Drug

Intervention Name(s)

Injectable Placebo

Intervention Description

Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.

Primary Outcome Measure Information:

Title

Description

Time Frame

Baseline (the last measurement prior to first dosing on Day 1), Week 12

Title

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=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 in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16

Title

Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16

Description

Time Frame

Baseline, Week 2, 4, 8 and 16

Title

Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16

Description

Time Frame

Baseline, Week 2, 4, 8 and 16

Title

Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 2, 4, 8, 12 and 16

Title

Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 2, 4, 8,12 and 16

Title

Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 2, 4, 8, 12 and 16

Title

Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS

Description

Time Frame

Baseline up to Week 16

Title

Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 2, 4, 8, 12 and 16

Title

Percentage BSA at Week 18 and 20

Description

Time Frame

Week 18 and 20

Title

Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 2, 4, 8, 12 and 16

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16

Description

Time Frame

Baseline, Week 2, 12 and 16

Title

DLQI at Week 20

Description

Time Frame

Week 20

Title

Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16

Description

Time Frame

Baseline, Week 12 and 16

Title

Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16

Description

Time Frame

Baseline, Week 12 and 16

Title

EQ-5D-5L- Index Value at Week 20

Description

Time Frame

Week 20

Title

EQ-5D-5L- VAS Score at Week 20

Description

Time Frame

Week 20

Title

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16

Description

Time Frame

Baseline, Weeks 12 and 16

Title

Change From Baseline in HADS - Depression Scale at Week 12 and 16

Description

Time Frame

Baseline, Week 12 and 16

Title

HADS - Anxiety Scale at Week 20

Description

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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

Week 20

Title

HADS - Depression Scale at Week 20

Description

Time Frame

Week 20

Title

Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16

Description

Time Frame

Baseline, Week 12 and 16

Title

POEM at Week 20

Description

Time Frame

Week 20

Title

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16

Description

Time Frame

Baseline, Week 1 to Week 16

Title

PSAAD Total Score at Week 18 and 20

Description

Time Frame

Week 18 and 20

Title

Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 2, 4, 8 12 and 16

Title

Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16

Description

Time Frame

Baseline, Week 2, 4, 8 12 and 16

Title

Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16

Description

Time Frame

Baseline, Week 2, 4, 8 12 and 16

Title

SCORAD VAS of Itch and Sleep Loss at Week 18 and 20

Description

Time Frame

Week 18 and 20

Title

Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16

Description

Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure.

Time Frame

Baseline up to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects aged 18 years or older at the time of informed consent 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) Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease. Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization; Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product. Female subjects of non-childbearing potential must meet at least 1 of the following criteria: Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure; or Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. -If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study Exclusion Criteria: Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study 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 Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study Other active nonAD inflammatory skin diseases or conditions affecting skin Prior treatment with JAK inhibitors Previous treatment with dupilumab Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

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

The University Of Alabama At Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Marvel Research, LLC

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Alliance Research Centers

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Allergy & Asthma Care Center of Southern California

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

Allergy & Asthma Associates of Southern California dba Southern California Research

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Dermatology Specialists, Inc.

City

Murrieta

State/Province

California

ZIP/Postal Code

92562

Country

United States

Facility Name

MedDerm Associates

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Clinical Science Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Synexus Clinical Research US, Inc.

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

Facility Name

IMMUNOe Research Centers

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Renaissance Research and Medical Group, Inc

City

Cape Coral

State/Province

Florida

ZIP/Postal Code

33991

Country

United States

Facility Name

C & R Research Services USA, Inc

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

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

Moonshine Research Center, Inc.

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Solutions Through Advanced Research, Inc.

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Olympian Clinical Research

City

Largo

State/Province

Florida

ZIP/Postal Code

33770

Country

United States

Facility Name

Wellness Clinical Research, LLC

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Savin Medical Group LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

ForCare Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Research Institute of Southeast, LLC

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Research Institute of the Southeast, LLC

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Columbus Regional Research Institute

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Idaho Allergy and Research

City

Eagle

State/Province

Idaho

ZIP/Postal Code

83616

Country

United States

Facility Name

ASR, LLC

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83687

Country

United States

Facility Name

Great Lakes Clinical Trials

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Midwest Allergy Sinus Asthma, SC

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

NorthShore University HealthSystem

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Southern Illinois University School of Medicine

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Dundee Dermatology

City

West Dundee

State/Province

Illinois

ZIP/Postal Code

60118

Country

United States

Facility Name

The Indiana Clinical Trials Center

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Forefront Dermatology, S.C.

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Clinical Research Institute, Inc.

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Skin Laser and Surgery Specialists of NY and NJ

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Forest Hills Dermatology Group

City

Kew Gardens

State/Province

New York

ZIP/Postal Code

11374

Country

United States

Facility Name

Juva Skin and Laser Center

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

TrialSpark, Inc (Russell Cohen)

City

Oceanside

State/Province

New York

ZIP/Postal Code

11572

Country

United States

Facility Name

Cary Dermatology Center, PA

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27511

Country

United States

Facility Name

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Medication Management, LLC

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Winston-Salem Dermatology and Surgery Center, PLLC

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Newton Clinical Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

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

Portland Clinical Research dba Columbia Allergy & Asthma Clinic

City

Clackamas

State/Province

Oregon

ZIP/Postal Code

97015

Country

United States

Facility Name

Crisor, LLC

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Oregon Health & Science University (OHSU)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Paddington Testing Co, Inc.

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Facility Name

Synexus Clinical Research US, Inc.

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Synexus Clinical Research US. Inc.

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Health Concepts

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

Arlington Research Center, Inc.

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Austin Institute for Clinical Research, Inc.

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

Center for Clinical Studies, LTD. LLP

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Jordan Valley Dermatology Center

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

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

Velocity Urgent Care

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23518

Country

United States

Facility Name

Woden Dermatology

City

Phillip

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

Australian Clinical Research Network

City

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

North Eastern Health Specialists

City

Hectorville

State/Province

South Australia

ZIP/Postal Code

5073

Country

Australia

Facility Name

Box Hill Hospital

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

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

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

DCC 2/Sofia EOOD

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

"DCC Aleksandrovska" EOOD

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Dermatology Clinic "Sofia" Ltd

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

"Mc Synexus Sofia" Eood

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Medical Centre Synexus Sofia EOOD-branch Stara Zagora

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

"DCC "Mladost-M Varna" OOD

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Pacific Dermaesthetics Inc.

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H4E1

Country

Canada

Facility Name

Wiseman Dermatology Research Inc.

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3M3Z4

Country

Canada

Facility Name

DermEffects

City

London

State/Province

Ontario

ZIP/Postal Code

N6H 5L5

Country

Canada

Facility Name

Lynderm Research Inc.

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

North Bay Dermatology Centre

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 3Z7

Country

Canada

Facility Name

SKiN Centre for Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J5K2

Country

Canada

Facility Name

Toronto Research Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3H5Y8

Country

Canada

Facility Name

AvantDerm Clinical Research

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5A 3R6

Country

Canada

Facility Name

Manna Research (Toronto)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Innovaderm Research Inc.

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 2V1

Country

Canada

Facility Name

Dr. Rachel Asiniwasis Medical Prof Corp

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4V1R9

Country

Canada

Facility Name

Centro Medico SkinMed Limitada

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

7580206

Country

Chile

Facility Name

Clinica Dermacross S.A.

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

7640881

Country

Chile

Facility Name

Centro Internacional de Estudios Clinicos - CIEC

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

8420383

Country

Chile

Facility Name

MIRES (M y F Estudios Clínicos Limitada)

City

Santiago

State/Province

Región Metropolitana

ZIP/Postal Code

7750495

Country

Chile

Facility Name

Dermamedica S.R.O.

City

Nachod

ZIP/Postal Code

547 01

Country

Czechia

Facility Name

CCR Ostrava, s.r.o.

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

BENU Lekarna

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

CCR Czech, a.s.

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie

City

Pardubice

ZIP/Postal Code

532 03

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

Synexus Czech, s.r.o.

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

CCR Prague, s.r.o.

City

Praha 3

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Licca Clinical Research Institute

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Fachklinik Bad Bentheim

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Klinikum Bielefeld Rosenhohe

City

Bielefeld

ZIP/Postal Code

33647

Country

Germany

Facility Name

Universitätsklinikum Bonn AöR

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Klinische Forschung Dresden GmbH

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Universitätsklinikum und Poliklinik für Dermatologie und Venerologie

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Studienzentrum Dr. med. Beate Schwarz

City

Langenau

ZIP/Postal Code

89129

Country

Germany

Facility Name

SIBAmed Studienzentrum GmbH & Co KG

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein/Campus Luebeck

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Universitätsklinikum Marburg

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

University of Muenster

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

SE AOK Bor-, Nemikortani es Boronkologiai Klinika

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Trial Pharma Kft.

City

Püspökladány

ZIP/Postal Code

4150

Country

Hungary

Facility Name

Medmare Bt

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Facility Name

AOU Policlinico di Modena, Struttura Complessa di Dermatologia

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Kawashima Dermatology Clinic

City

Ichikawa

State/Province

Chiba

ZIP/Postal Code

272-0033

Country

Japan

Facility Name

Takagi Dermatological Clinic

City

Obihiro

State/Province

Hokkaido

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

Dermatology Shimizu Clinic

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

657-0846

Country

Japan

Facility Name

Noguchi Dermatology Clinic

City

Kamimashiki-gun

State/Province

Kumamoto

ZIP/Postal Code

861-3101

Country

Japan

Facility Name

Osaka Habikino Medical Center

City

Habikino

State/Province

Osaka

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

Kume Clinic

City

Sakai

State/Province

Osaka

ZIP/Postal Code

593-8324

Country

Japan

Facility Name

Iidabashi Skin Clinic

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

102-0072

Country

Japan

Facility Name

Fukuwa Clinic

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Tokyo Medical University Hospital

City

Shinjyuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

Hoshikuma Dermatology・Allergy Clinic

City

Fukuoka

ZIP/Postal Code

814-0171

Country

Japan

Facility Name

Matsuda Tomoko Dermatological Clinic

City

Fukuoka

ZIP/Postal Code

819-0167

Country

Japan

Facility Name

Sanrui Hifuka

City

Saitama

ZIP/Postal Code

330-0854

Country

Japan

Facility Name

Korea University Ansan Hospital

City

Ansan-si

State/Province

Gyeonggi-do

ZIP/Postal Code

15355

Country

Korea, Republic of

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

Chungnam National University Hospital CNUH

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

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

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei Univ. Health System

City

Seoul

ZIP/Postal Code

03722

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

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

Childrens Clinical University Hospital State SLLC

City

Riga

ZIP/Postal Code

LV-1004

Country

Latvia

Facility Name

Health and aesthetics Ltd

City

Riga

ZIP/Postal Code

LV-1009

Country

Latvia

Facility Name

Outpatient Clinic of Ventspils

City

Ventspils

ZIP/Postal Code

LV-3601

Country

Latvia

Facility Name

Cryptex Investigación Clínica, S.A. de C.V.

City

Cuauhtemoc

State/Province

Mexico CITY

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Arke Estudios Clinicos S.A. de C.V.

City

Cuauhtemoc

State/Province

Mexico CITY

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Eukarya Pharmasite S.C.

City

Monterrey

State/Province

Nuevo LEON

ZIP/Postal Code

64718

Country

Mexico

Facility Name

SMIQ. S. de R. L. de C.V.

City

Queretaro

ZIP/Postal Code

76070

Country

Mexico

Facility Name

NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL"

City

Bialystok

ZIP/Postal Code

15-453

Country

Poland

Facility Name

Centrum Medyczne SENSEMED

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

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

City

Czestochowa

ZIP/Postal Code

42-202

Country

Poland

Facility Name

COPERNICUS-SZPITAL Oddzial Dermatologii

City

Gdansk

ZIP/Postal Code

80-152

Country

Poland

Facility Name

Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii

City

Gdansk

ZIP/Postal Code

80-214

Country

Poland

Facility Name

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

City

Gdynia

ZIP/Postal Code

81-537

Country

Poland

Facility Name

MCBK

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

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

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Care Clinic Centrum Medyczne

City

Katowice

ZIP/Postal Code

40-568

Country

Poland

Facility Name

Centrum Medyczne Angelius Provita

City

Katowice

ZIP/Postal Code

40-611

Country

Poland

Facility Name

Gabinet Dermatologiczny Beata Krecisz

City

Kielce

ZIP/Postal Code

25-155

Country

Poland

Facility Name

Centrum Medyczne Plejady

City

Krakow

ZIP/Postal Code

30-363

Country

Poland

Facility Name

AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc

City

Krakow

ZIP/Postal Code

31-302

Country

Poland

Facility Name

Krakowskie Centrum Medyczne Sp. z o.o.

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Centrum Medyczne Promed

City

Krakow

ZIP/Postal Code

31-513

Country

Poland

Facility Name

Prywatna Praktyka Lekarska - Adam Smialowski

City

Ksawerow

ZIP/Postal Code

95-054

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

Salve Medica Sp. z o.o. Sp. k.

City

Lodz

ZIP/Postal Code

91-211

Country

Poland

Facility Name

KO-MED Centra Kliniczne Lublin II

City

Lublin

ZIP/Postal Code

20-362

Country

Poland

Facility Name

NZOZ "Med-Laser" Borzecki Spolka Jawna

City

Lublin

ZIP/Postal Code

20-406

Country

Poland

Facility Name

Dermedic Jacek Zdybski

City

Ostrowiec Swietokrzyski

ZIP/Postal Code

27-400

Country

Poland

Facility Name

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

City

Poznan

ZIP/Postal Code

60-702

Country

Poland

Facility Name

Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.

City

Poznan

ZIP/Postal Code

60-848

Country

Poland

Facility Name

LIFT-MED Spolka Akcyjna

City

Rybnik

ZIP/Postal Code

44-200

Country

Poland

Facility Name

Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii

City

Rzeszow

ZIP/Postal Code

35-055

Country

Poland

Facility Name

EMED Centrum Uslug Medycznych Ewa Smialek

City

Rzeszow

ZIP/Postal Code

35-205

Country

Poland

Facility Name

Twoja Przychodnia - Szczecinskie Centrum Medyczne

City

Szczecin

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Medycyna Kliniczna

City

Warszawa

ZIP/Postal Code

00-874

Country

Poland

Facility Name

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

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

MTZ Clinical Research Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

RCMed Oddzial Warszawa

City

Warszawa

ZIP/Postal Code

02-657

Country

Poland

Facility Name

Carpe Diem Centrum Medycyny Estetycznej

City

Warszawa

ZIP/Postal Code

02-661

Country

Poland

Facility Name

"REUMATIKA - Centrum Reumatologii" NZOZ

City

Warszawa

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Klinika Ambroziak Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-758

Country

Poland

Facility Name

EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

City

Wroclaw

ZIP/Postal Code

50-220

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

Wroclaw

ZIP/Postal Code

50-566

Country

Poland

Facility Name

Centrum Medyczne Oporow

City

Wroclaw

ZIP/Postal Code

52-416

Country

Poland

Facility Name

SUMMIT CLINICAL RESEARCH, s.r.o.

City

Bratislava

ZIP/Postal Code

831 01

Country

Slovakia

Facility Name

Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica

City

Kosice-Saca

ZIP/Postal Code

040 15

Country

Slovakia

Facility Name

Pedi-Derma s.r.o.

City

Kosice

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika

City

Nove Zamky

ZIP/Postal Code

940 34

Country

Slovakia

Facility Name

SANARE spol. s.r.o., Dermatovenerologicka ambulancia

City

Svidnik

ZIP/Postal Code

089 01

Country

Slovakia

Facility Name

Hospital Universitari Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08016

Country

Spain

Facility Name

Hospital Universitari Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Universitario Fundacion Alcorcon

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Hospital Universitario Puerta de Hierro de Majadahonda

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario y Politecnico La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Taipei Veterans General Hospital

City

Taipei

State/Province

Taiwan (r.o.c)

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital (CSMUH)

City

Taichung City

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

National Cheng-Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Mackay Memorial Hospital

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Medinova Research -West London Dedicated Research Centre

City

Wokingham

State/Province

Berkshire

ZIP/Postal Code

RG40 1XS

Country

United Kingdom

Facility Name

Derriford Hospital

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Medinova Research, East London Dedicated Research Centre

City

Romford

State/Province

Essex

ZIP/Postal Code

RM1 3PJ

Country

United Kingdom

Facility Name

Guy's Hospital-Guy's and St Thomas NHS Foundation Trust

City

London

State/Province

Greater London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Medinova Research, South London Clinical Trial Centre

City

Sidcup

State/Province

Kent

ZIP/Postal Code

DA14 6LT

Country

United Kingdom

Facility Name

MeDiNova Research North London Dedicated Research Centre

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Medinova Research

City

Yaxley

State/Province

Peterborough

ZIP/Postal Code

PE7 3JL

Country

United Kingdom

Facility Name

Medinova Research, Warwickshire Dedicated Research Centre

City

Kenilworth

State/Province

Warwickshire

ZIP/Postal Code

CV8 1JD

Country

United Kingdom

Facility Name

Medinova, Yorkshire Quality Research Site

City

Shipley

State/Province

WEST Yorkshire

ZIP/Postal Code

BD18 3SA

Country

United Kingdom

Facility Name

MeDiNova Northamptonshire Dedicated Research Centre

City

Corby

ZIP/Postal Code

NN18 9EZ

Country

United Kingdom

Facility Name

West Glasgow ACH, NHS Greater Glasgow and Clyde

City

Glasgow

ZIP/Postal Code

G3 8SJ

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

36108923

Citation

Reich K, Lio PA, Bissonnette R, Alexis AF, Lebwohl MG, Pink AE, Kabashima K, Boguniewicz M, Nowicki RJ, Valdez H, Zhang F, DiBonaventura M, Cameron MC, Clibborn C. Magnitude and Time Course of Response to Abrocitinib for Moderate-to-Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2022 Dec;10(12):3228-3237.e2. doi: 10.1016/j.jaip.2022.08.042. Epub 2022 Sep 13.

Results Reference

derived

PubMed Identifier

35297025

Citation

Alexis A, de Bruin-Weller M, Weidinger S, Soong W, Barbarot S, Ionita I, Zhang F, Valdez H, Clibborn C, Yin N. Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study. Dermatol Ther (Heidelb). 2022 Mar;12(3):771-785. doi: 10.1007/s13555-022-00694-1. Epub 2022 Mar 17.

Results Reference

derived

PubMed Identifier

34775830

Citation

Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H. Comparing abrocitinib and dupilumab in the treatment of atopic dermatitis: a plain language summary. Immunotherapy. 2022 Jan;14(1):5-14. doi: 10.2217/imt-2021-0224. Epub 2021 Nov 15.

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

33761207

Citation

Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H; JADE COMPARE Investigators. Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis. N Engl J Med. 2021 Mar 25;384(12):1101-1112. doi: 10.1056/NEJMoa2019380.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=B7451029

Description

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

Learn more about this trial

Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

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