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Dermatitis, AtopicPhase 3JADE Mono-2NCT03575871

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

A Phase 3 study testing PF-04965842 100 mg and PF-04965842 200 mg in people with Dermatitis, Atopic, run by Pfizer at 115 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Dermatitis, Atopic
What is being tested?
PF-04965842 100 mg and PF-04965842 200 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
391 participants
Where
115 sitesin 13 countries
Study dates
29 Jun 2018to 13 Aug 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

115 sites in 13 countries.

115 sites in 13 countries

United States28 sites

  • Emmaus Research Center, Inc.

    Anaheim, California, 92804

  • Austin Institute for Clinical Research, Inc. - Central

    Austin, Texas, 78705

  • Meridian Clinical Research

    Baton Rouge, Louisiana, 70808

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Imaging Center of Idaho

    Caldwell, Idaho, 83605

  • Olympian Clinical Research

    Clearwater, Florida, 33756

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado, 80907

  • Colorado Springs Dermatology Clinic, PC

    Colorado Springs, Colorado, 80910

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Summit Clinical Research, LLC

    Franklin, Virginia, 23851

  • The Ohio State University Dermatology East

    Gahanna, Ohio, 43230

  • Center for Clinical Studies, LTD. LLP

    Houston, Texas, 77004

  • West Houston Dermatology, PA

    Houston, Texas, 77082

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Precision Imaging

    Jacksonville, Florida, 32256

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida, 32256

  • Advanced Research Center, Inc. - Los Alamitos Site

    Los Alamitos, California, 90720

  • Tanenbaum Dermatology Center

    Memphis, Tennessee, 38117

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • ASR, LLC

    Nampa, Idaho, 83687

  • Sadick Research Group

    New York, New York, 10075

  • Virginia Dermatology and Skin Cancer Center

    Norfolk, Virginia, 23502

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Peninsula Research Associates, Inc.

    Rolling Hills Estates, California, 90274

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Clinical Science Institute

    Santa Monica, California, 90404

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28411

Other trials in United States

Poland15 sites

  • NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.

    Bialystok, 15-453

  • KLIMED Marek Klimkiewicz

    Bialystok, 15-704

  • Centrum Badań Klinicznych JCI

    Krakow, 30-348

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

    Krakow, 31-011

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501

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

    Lodz, 90-242

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

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

    Poznan, 60-848

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

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

    Warsaw, 01-192

  • Centrum Medyczne AMED

    Warsaw, 01-518

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02-106

  • Klinika Ambroziak Sp. z o.o.

    Warsaw, 02-758

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

    Wroclaw, 50-381

  • Lukasz Matusiak "4HEALTH"

    Wroclaw, 50-566

Other trials in Poland

South Korea10 sites

  • Soon Chun Hyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do, 14584

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

    Bupyeong-gu, Incheon, 21431

  • Kyungpook National University Hospital

    Daegu, 41944

  • Chonnam National University Hospital

    Gwangju, 61469

  • Inha University Hospital

    Jung-gu, Incheon, 22332

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital, Yonsei Univ. Health System

    Seoul, 03722

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

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Hallym university Kangnam Sacred Heart Hospital

    Seoul, 07441

Other trials in South Korea

Japan8 sites

  • Sumire Dermatology Clinic

    Edogawa-ku, Tokyo, 133-0057

  • Hoshikuma Dermatology・Allergy Clinic

    Fukuoka, 814-0171

  • Noguchi Dermatology Clinic

    Kamimashiki-gun, Kumamoto, 861-3101

  • Matsuyama Dermatology Clinic

    Nakano-ku, Tokyo, 165-0026

  • Yoshioka Dermatology Clinic

    Neyagawa, Osaka, 572-0838

  • Sanrui Hifuka

    Saitama, 330-0854

  • Kume Clinic

    Sakai, Osaka, 593-8324

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

    Yokohama, Kanagawa, 220-6208

Other trials in Japan

Australia7 sites

  • The Skin Centre

    Benowa, Queensland, 4217

  • Skin and Cancer Foundation Inc

    Carlton, VIC 3053

  • Sinclair Dermatology

    East Melbourne, Victoria, 3002

  • Australian Clinical Research Network

    Maroubra, New South Wales, 2035

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • The Royal Children's Hospital (RCH)

    Parkville, Victoria, 3052

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada7 sites

  • North York Research Inc.

    North York, Ontario, M2M 4J5

  • Oshawa Clinic Dermatology Trials

    Oshawa, Ontario, L1H 1B9

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario, L4C 9M7

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Research Toronto

    Toronto, Ontario, M4W 2N2

  • University of British Columbia Department of Dermatology and Skin Science

    Vancouver, British Columbia, V5Z 4E8

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Czechia7 sites

  • Dermamedica S.R.O.

    Náchod, 547 01

  • Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni

    Náchod, 547 01

  • Lekarna u Stribrneho orla

    Náchod, 54701

  • Sanatorium profesora Arenbergera

    Prague, 11000

  • Lekarna U sv. Ignace

    Prague, 120 00

  • Dermatologicka Ambulance

    Svitavy, 568 02

  • Lekarna na Hranicni

    Svitavy, 56802

Other trials in Czechia

Germany7 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • ISA GmbH

    Berlin, 10789

  • Fachärztliche Gemeinschaftspraxis für Dermatologie und Venerologie, Allergologie,

    Blankenfelde-Mahlow, 15831

  • IKF Pneumologie GmbH & Co KG

    Frankfurt, 60596

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • Universitaet Muenster

    Münster, 48149

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

Other trials in Germany

Bulgaria6 sites

  • Medical Centre Asklepii OOD

    Dupnitsa, 2600

  • MHAT Dr. Tota Venkova AD

    Gabrovo, 5300

  • "Acibadem City Clinic MHAT Tokuda" EAD

    Sofia, 1407

  • "DCC Aleksandrovska" EOOD

    Sofia, 1431

  • Diagnostic Consultative Center Fokus-5

    Sofia, 1463

  • Medical Centre Synexus Sofia EOOD

    Sofia, 1784

Other trials in Bulgaria

United Kingdom6 sites

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, South Yorkshire, S75 2EP

  • MAC Clinical Research

    Blackpool, Lancashire, FY2 0JH

  • University Hospital Bristol NHS Foundation Trust

    Bristol, BS2 8HW

  • MAC Clinical Research Ltd

    Cannock, South Staffordshire, WS11 0BN

  • MAC Clinical Research Ltd

    Manchester, M13 9NQ

  • Plymouth Hospitals NHS Trust, Derriford Hospital

    Plymouth, Devon, PL6 8DH

Other trials in United Kingdom

China5 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The Second Affiliated Hospital of Army Medical University, PLA

    Chongqing, Chongqing Municipality, 400037

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, Guangdong, 518053

  • Tianjin Medical University General Hospital, Dermatological Department

    Tianjin, 300052

Other trials in China

Latvia5 sites

  • Selga Freiberga private practice in dermatovenerology and cosmetology

    Jelgava, LV-3001

  • Riga 1st Hospital, Clinic for Dermatology and STD

    Riga, LV-1001

  • Aesthetic dermatology clinic of Prof. J. Kisis

    Riga, LV-1003

  • Health Centre 4 Ltd. Diagnostics Centre

    Riga, LV-1003

  • Health Centre 4 Ltd

    Riga, LV-1013

Other trials in Latvia

Hungary4 sites

  • SE AOK Bor, Nemikortani es Boronkologiai Klinika

    Budapest, 1085

  • Budapest Főváros XIX. Kerületi Önkormányzat Kispesti Egészsegügyi Intézete

    Budapest, 1195

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • ALLERGO-DERM BAKOS Kft.

    Szolnok, 5000

Other trials in Hungary

About this study

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

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Being tested
PF-04965842 100 mg, PF-04965842 200 mg, Placebo
Keywords
atopic dermatitis, atopic eczema, eczema, JAK, janus kinase
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-04965842 100 mgDrug

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

  • PF-04965842 200 mgDrug

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

  • PlaceboDrug

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

Study groups in NCT03575871
Study groupRoleWhat they receive
PF-04965842 100 mgExperimentalNot described
Receives: Drug: PF-04965842 100 mg
PF-04965842 200 mgExperimentalNot described
Receives: Drug: PF-04965842 200 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline, Week 12

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

    EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks] on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

    Measured: Baseline, Week 12

Secondary outcomes (17)

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

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

    Measured: Baseline, Weeks 2, 4, 8 and 12

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

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

    Measured: Baseline, Week 12

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

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

    Measured: Baseline up to Day 15

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

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

    Measured: Baseline, Weeks 2, 4, and 8

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

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

    Measured: Baseline, Weeks 2, 4, and 8

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

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

    Measured: Weeks 2, 4, 8 and 12

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

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

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

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

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

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

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

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

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

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

  12. Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12

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

    Measured: Weeks 2, 4, 8, and 12

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

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

  14. Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

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

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

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

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

  17. Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12

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

    Measured: Baseline, Weeks 2, 4, 8, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2018
  2. Study start29 Jun 2018
  3. Primary completion13 Aug 2019
  4. Study completion13 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03575871
Sponsor's protocol ID
B7451013
Other IDs
MONO-2, 2018-001136-21, 2018
Acronym
JADE Mono-2
Status last verified
Apr 2020
First submitted
15 Jun 2018
Last updated
21 Apr 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Silverberg JI, Simpson EL, Farooqui SA, Chan G, Biswas P, Guler E. Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis. Dermatol Ther (Heidelb). 2026 May 20. doi: 10.1007/s13555-026-01778-y. Online ahead of print.

    PubMed 42162528

  • Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.

    PubMed 40028832

  • Silverberg 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.

    PubMed 39104653

  • Armstrong 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.

    PubMed 38896380

  • Schmid-Grendelmeier P, Gooderham MJ, Hartmann K, Konstantinou GN, Fellmann M, Koulias C, Clibborn C, Biswas P, Brunner PM. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. Allergy. 2024 Jan;79(1):174-183. doi: 10.1111/all.15952. Epub 2023 Nov 21.

    PubMed 37988255

  • Alexis AF, Silverberg JI, Rice ZP, Armstrong AW, Desai SR, Fonacier L, Kabashima K, Biswas P, Cella RR, Chan GL, Levenberg M. Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type. Ann Allergy Asthma Immunol. 2024 Mar;132(3):383-389.e3. doi: 10.1016/j.anai.2023.11.002. Epub 2023 Nov 10.

    PubMed 37949351

  • Yosipovitch G, Gooderham MJ, Stander S, Fonacier L, Szepietowski JC, Deleuran M, Girolomoni G, Su JC, Bushmakin AG, Cappelleri JC, Feeney C, Chan G, Thorpe AJ, Valdez H, Biswas P, Rojo R, DiBonaventura M, Myers DE. Interpreting the Relationship Among Itch, Sleep, and Work Productivity in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE MONO-2. Am J Clin Dermatol. 2024 Jan;25(1):127-138. doi: 10.1007/s40257-023-00810-7. Epub 2023 Aug 25.

    PubMed 37624488

  • Blauvelt A, Boguniewicz M, Brunner PM, Luna PC, Biswas P, DiBonaventura M, Farooqui SA, Rojo R, Cameron MC. Abrocitinib monotherapy in Investigator's Global Assessment nonresponders: improvement in signs and symptoms of atopic dermatitis and quality of life. J Dermatolog Treat. 2022 Aug;33(5):2605-2613. doi: 10.1080/09546634.2022.2059053. Epub 2022 Jul 6.

    PubMed 35763326

  • Stander S, Bhatia N, Gooderham MJ, Silverberg JI, Thyssen JP, Biswas P, DiBonaventura M, Romero W, Farooqui SA. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 Aug;36(8):1308-1317. doi: 10.1111/jdv.18170. Epub 2022 May 6.

    PubMed 35462428

  • Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.

    PubMed 35342978

  • Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.

    PubMed 35061234

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

    PubMed 34743361

  • 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.

    PubMed 34406619

  • Silverberg JI, Thyssen JP, Simpson EL, Yosipovitch G, Stander S, Valdez H, Rojo R, Biswas P, Myers DE, Feeney C, DiBonaventura M. Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes. Am J Clin Dermatol. 2021 Jul;22(4):541-554. doi: 10.1007/s40257-021-00604-9. Epub 2021 May 5.

    PubMed 33954933

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

    PubMed 32492087

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-04965842 100 mg and PF-04965842 200 mg in people with Dermatitis, Atopic, run by Pfizer at 115 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Poland, South Korea, Japan, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12 (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03575871, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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