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
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
3 other identifiers
interventional
838
18 countries
216
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
Shorter than P25 for phase_3
216 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedStudy Start
First participant enrolled
October 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2020
CompletedResults Posted
Study results publicly available
January 19, 2021
CompletedJanuary 19, 2021
December 1, 2020
1.2 years
October 24, 2018
December 21, 2020
December 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline (the last measurement prior to first dosing on Day 1), Week 12
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.
Baseline, Week 12
Secondary Outcomes (29)
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
Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16
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
Baseline, Week 2, 4, 8 and 16
Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16
Baseline, Week 2, 4, 8 and 16
Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Baseline, Week 2, 4, 8, 12 and 16
Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Baseline, Week 2, 4, 8,12 and 16
- +24 more secondary outcomes
Study Arms (5)
PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg
EXPERIMENTALOnce-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
PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg
EXPERIMENTALOnce-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 Injection + Oral Placebo followed by Oral Placebo
ACTIVE COMPARATORDupilumab 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
Oral Placebo + Placebo Inj followed by 100 mg PF-04965842
PLACEBO COMPARATOROnce-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
Oral Placebo + Placebo Inj followed by 200 mg PF-04965842
PLACEBO COMPARATOROnce-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
Interventions
PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows: 1. 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; 2. 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.
PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows: 1. 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; 2. 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.
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.
Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: 1. 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; 2. 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (216)
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35209, United States
The University Of Alabama At Birmingham
Birmingham, Alabama, 35233, United States
Marvel Research, LLC
Huntington Beach, California, 92647, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Allergy & Asthma Care Center of Southern California
Long Beach, California, 90808, United States
Allergy & Asthma Associates of Southern California dba Southern California Research
Mission Viejo, California, 92691, United States
Dermatology Specialists, Inc.
Murrieta, California, 92562, United States
MedDerm Associates
San Diego, California, 92103, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Synexus Clinical Research US, Inc.
Santa Rosa, California, 95405, United States
IMMUNOe Research Centers
Centennial, Colorado, 80112, United States
Renaissance Research and Medical Group, Inc
Cape Coral, Florida, 33991, United States
C & R Research Services USA, Inc
Coral Gables, Florida, 33134, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134, United States
Moonshine Research Center, Inc.
Doral, Florida, 33166, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256, United States
Olympian Clinical Research
Largo, Florida, 33770, United States
Savin Medical Group LLC
Miami, Florida, 33126, United States
Wellness Clinical Research, LLC
Miami Lakes, Florida, 33016, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Research Institute of Southeast, LLC
West Palm Beach, Florida, 33401, United States
Research Institute of the Southeast, LLC
West Palm Beach, Florida, 33401, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Idaho Allergy and Research
Eagle, Idaho, 83616, United States
ASR, LLC
Nampa, Idaho, 83687, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Midwest Allergy Sinus Asthma, SC
Normal, Illinois, 61761, United States
NorthShore University HealthSystem
Skokie, Illinois, 60077, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Forefront Dermatology, S.C.
Louisville, Kentucky, 40202, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70808, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Skin Laser and Surgery Specialists of NY and NJ
Hackensack, New Jersey, 07601, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11374, United States
Juva Skin and Laser Center
New York, New York, 10022, United States
TrialSpark, Inc (Russell Cohen)
Oceanside, New York, 11572, United States
Cary Dermatology Center, PA
Cary, North Carolina, 27511, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518, United States
Medication Management, LLC
Greensboro, North Carolina, 27408, United States
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
Statesville, North Carolina, 28625, United States
Winston-Salem Dermatology and Surgery Center, PLLC
Winston-Salem, North Carolina, 27103, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Newton Clinical Research
Oklahoma City, Oklahoma, 73120, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Portland Clinical Research dba Columbia Allergy & Asthma Clinic
Clackamas, Oregon, 97015, United States
Crisor, LLC
Medford, Oregon, 97504, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239, United States
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, 19103, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, 29621, United States
Synexus Clinical Research US. Inc.
Greer, South Carolina, 29651, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
Austin Institute for Clinical Research, Inc.
Austin, Texas, 78705, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, 77598, United States
Jordan Valley Dermatology Center
West Jordan, Utah, 84088, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502, United States
Velocity Urgent Care
Norfolk, Virginia, 23518, United States
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
Australian Clinical Research Network
Maroubra, New South Wales, 2035, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
North Eastern Health Specialists
Hectorville, South Australia, 5073, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Skin and Cancer Foundation Inc
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
DCC 2/Sofia EOOD
Sofia, 1000, Bulgaria
"DCC Aleksandrovska" EOOD
Sofia, 1431, Bulgaria
Dermatology Clinic "Sofia" Ltd
Sofia, 1756, Bulgaria
"Mc Synexus Sofia" Eood
Sofia, 1784, Bulgaria
Medical Centre Synexus Sofia EOOD-branch Stara Zagora
Stara Zagora, 6000, Bulgaria
"DCC "Mladost-M Varna" OOD
Varna, 9000, Bulgaria
Pacific Dermaesthetics Inc.
Vancouver, British Columbia, V6H4E1, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M3Z4, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J5K2, Canada
Toronto Research Centre
Toronto, Ontario, M3H5Y8, Canada
AvantDerm Clinical Research
Toronto, Ontario, M5A 3R6, Canada
Manna Research (Toronto)
Toronto, Ontario, M9W 4L6, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Dr. Rachel Asiniwasis Medical Prof Corp
Regina, Saskatchewan, S4V1R9, Canada
Centro Medico SkinMed Limitada
Santiago, Santiago Metropolitan, 7580206, Chile
Clinica Dermacross S.A.
Santiago, Santiago Metropolitan, 7640881, Chile
MIRES (M y F Estudios Clínicos Limitada)
Santiago, Santiago Metropolitan, 7750495, Chile
Centro Internacional de Estudios Clinicos - CIEC
Santiago, Santiago Metropolitan, 8420383, Chile
Dermamedica S.R.O.
Náchod, 547 01, Czechia
CCR Ostrava, s.r.o.
Ostrava, 702 00, Czechia
BENU Lekarna
Pardubice, 530 02, Czechia
CCR Czech, a.s.
Pardubice, 530 02, Czechia
Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie
Pardubice, 532 03, Czechia
Sanatorium profesora Arenbergera
Prague, 11000, Czechia
Lekarna U sv. Ignace
Prague, 120 00, Czechia
Synexus Czech, s.r.o.
Prague, 120 00, Czechia
CCR Prague, s.r.o.
Prague, 130 00, Czechia
Licca Clinical Research Institute
Augsburg, 86179, Germany
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Klinikum Bielefeld Rosenhohe
Bielefeld, 33647, Germany
Universitätsklinikum Bonn AöR
Bonn, 53105, Germany
Klinische Forschung Dresden GmbH
Dresden, 01069, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, 01307, Germany
IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung
Frankfurt, 60596, Germany
Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
Halle, 06120, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Studienzentrum Dr. med. Beate Schwarz
Langenau, 89129, Germany
SIBAmed Studienzentrum GmbH & Co KG
Leipzig, 04103, Germany
Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
Lübeck, 23538, Germany
Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling
Mahlow, 15831, Germany
Universitätsklinikum Marburg
Marburg, 35043, Germany
University of Muenster
Münster, 48149, Germany
SE AOK Bor-, Nemikortani es Boronkologiai Klinika
Budapest, 1085, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS
Gyula, 5700, Hungary
Trial Pharma Kft.
Püspökladány, 4150, Hungary
Medmare Bt
Veszprém, 8200, Hungary
Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
Roma, RM, 00168, Italy
AOU Policlinico di Modena, Struttura Complessa di Dermatologia
Modena, 41124, Italy
Kawashima Dermatology Clinic
Ichikawa, Chiba, 272-0033, Japan
Takagi Dermatological Clinic
Obihiro, Hokkaido, 080-0013, Japan
Dermatology Shimizu Clinic
Kobe, Hyōgo, 657-0846, Japan
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, 861-3101, Japan
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588, Japan
Kume Clinic
Sakai, Osaka, 593-8324, Japan
Iidabashi Skin Clinic
Chiyoda-ku, Tokyo, 102-0072, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Tokyo Medical University Hospital
Shinjyuku-ku, Tokyo, 160-0023, Japan
Hoshikuma Dermatology・Allergy Clinic
Fukuoka, 814-0171, Japan
Matsuda Tomoko Dermatological Clinic
Fukuoka, 819-0167, Japan
Sanrui Hifuka
Saitama, 330-0854, Japan
Riga 1st Hospital, Clinic for Dermatology and STD
Riga, LV-1001, Latvia
Aesthetic dermatology clinic of Prof. J. Kisis
Riga, LV-1003, Latvia
Childrens Clinical University Hospital State SLLC
Riga, LV-1004, Latvia
Health and aesthetics Ltd
Riga, LV-1009, Latvia
Outpatient Clinic of Ventspils
Ventspils, LV-3601, Latvia
Cryptex Investigación Clínica, S.A. de C.V.
Cuauhtémoc, Mexico City, 06100, Mexico
Arke Estudios Clinicos S.A. de C.V.
Cuauhtémoc, Mexico City, 06700, Mexico
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, 64718, Mexico
SMIQ. S. de R. L. de C.V.
Querétaro, 76070, Mexico
NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL"
Bialystok, 15-453, Poland
Centrum Medyczne SENSEMED
Chorzów, 41-500, Poland
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, 42-202, Poland
COPERNICUS-SZPITAL Oddzial Dermatologii
Gdansk, 80-152, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
Gdansk, 80-214, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537, Poland
MCBK
Grodzisk Mazowiecki, 05-825, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040, Poland
Care Clinic Centrum Medyczne
Katowice, 40-568, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Gabinet Dermatologiczny Beata Krecisz
Kielce, 25-155, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc
Krakow, 31-302, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501, Poland
Centrum Medyczne Promed
Krakow, 31-513, Poland
Prywatna Praktyka Lekarska - Adam Smialowski
Ksawerów, 95-054, Poland
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
Lodz, 90-436, Poland
Salve Medica Sp. z o.o. Sp. k.
Lodz, 91-211, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
NZOZ "Med-Laser" Borzecki Spolka Jawna
Lublin, 20-406, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400, Poland
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, 60-702, Poland
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
Poznan, 60-848, Poland
LIFT-MED Spolka Akcyjna
Rybnik, 44-200, Poland
Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii
Rzeszów, 35-055, Poland
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, 35-205, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Medycyna Kliniczna
Warsaw, 00-874, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01-192, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
RCMed Oddzial Warszawa
Warsaw, 02-657, Poland
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, 02-661, Poland
"REUMATIKA - Centrum Reumatologii" NZOZ
Warsaw, 02-691, Poland
Klinika Ambroziak Sp. z o.o.
Warsaw, 02-758, Poland
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Wroclaw, 50-220, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, 50-381, Poland
Lukasz Matusiak "4Health"
Wroclaw, 50-566, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
SUMMIT CLINICAL RESEARCH, s.r.o.
Bratislava, 831 01, Slovakia
Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica
Kosice-Saca, 040 15, Slovakia
Pedi-Derma s.r.o.
Košice, 04001, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika
Nové Zámky, 940 34, Slovakia
SANARE spol. s.r.o., Dermatovenerologicka ambulancia
Svidník, 089 01, Slovakia
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584, South Korea
Chungnam National University Hospital CNUH
Daejeon, 35015, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431, South Korea
Severance Hospital, Yonsei Univ. Health System
Seoul, 03722, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08016, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Taipei Veterans General Hospital
Taipei, Taiwan (r.o.c), 11217, Taiwan
Chung Shan Medical University Hospital (CSMUH)
Taichung, 40201, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng-Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Medinova Research -West London Dedicated Research Centre
Wokingham, Berkshire, RG40 1XS, United Kingdom
Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
Medinova Research, East London Dedicated Research Centre
Romford, Essex, RM1 3PJ, United Kingdom
Guy's Hospital-Guy's and St Thomas NHS Foundation Trust
London, Greater London, SE1 9RT, United Kingdom
Medinova Research, South London Clinical Trial Centre
Sidcup, KENT, DA14 6LT, United Kingdom
MeDiNova Research North London Dedicated Research Centre
Northwood, Middlesex, HA6 2RN, United Kingdom
Medinova Research
Yaxley, Peterborough, PE7 3JL, United Kingdom
Medinova Research, Warwickshire Dedicated Research Centre
Kenilworth, Warwickshire, CV8 1JD, United Kingdom
Medinova, Yorkshire Quality Research Site
Shipley, WEST Yorkshire, BD18 3SA, United Kingdom
MeDiNova Northamptonshire Dedicated Research Centre
Corby, NN18 9EZ, United Kingdom
West Glasgow ACH, NHS Greater Glasgow and Clyde
Glasgow, G3 8SJ, United Kingdom
Related Publications (10)
Simpson EL, Silverberg JI, Geng B, Carrascosa JM, Bieber T, Brunner PM, Staumont-Salle D, Ji C, Biswas P, Feeney C, Hernandez-Martin I, Rebollo Laserna FJ, Koppensteiner H. Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis? Dermatol Ther (Heidelb). 2025 Nov;15(11):3391-3407. doi: 10.1007/s13555-025-01516-w. Epub 2025 Sep 23.
PMID: 40987931DERIVEDSilverberg JI, Thyssen JP, Lazariciu I, Myers DE, Guler E, Chovatiya R. Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis. Skin Health Dis. 2024 May 5;4(4):e382. doi: 10.1002/ski2.382. eCollection 2024 Aug.
PMID: 39104653DERIVEDArmstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.
PMID: 38896380DERIVEDSimpson EL, Silverberg JI, Thyssen JP, Viguier M, Thaci D, de Bruin-Weller M, Weidinger S, Chan G, DiBonaventura M, Biswas P, Feeney C, Koulias C, Cork MJ. Efficacy and Safety of Abrocitinib in Patients with Severe and/or Difficult-to-Treat Atopic Dermatitis: A Post Hoc Analysis of the Randomized Phase 3 JADE COMPARE Trial. Am J Clin Dermatol. 2023 Jul;24(4):609-621. doi: 10.1007/s40257-023-00785-5. Epub 2023 May 22.
PMID: 37213005DERIVEDStander S, Kwatra SG, Silverberg JI, Simpson EL, Thyssen JP, Yosipovitch G, Zhang F, Cameron MC, Cella RR, Valdez H, DiBonaventura M, Feeney C. Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial. Am J Clin Dermatol. 2023 Jan;24(1):97-107. doi: 10.1007/s40257-022-00738-4. Epub 2022 Dec 13.
PMID: 36512175DERIVEDReich 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.
PMID: 36108923DERIVEDAlexis 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.
PMID: 35297025DERIVEDBieber 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.
PMID: 34775830DERIVEDSimpson 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.
PMID: 34406619DERIVEDBieber 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.
PMID: 33761207DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2018
First Posted
October 25, 2018
Study Start
October 29, 2018
Primary Completion
December 27, 2019
Study Completion
March 6, 2020
Last Updated
January 19, 2021
Results First Posted
January 19, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
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.