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

NCT03349060 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: B74510122017-003651-29MONO-1JADE MONO-1
• Study Type: interventional
• Target: 387
• Locations: 8 countries
• Sites: 88

Brief Summary

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

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

Outcome Measures

Primary Outcomes (2)

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

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

  Baseline, Week 12

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

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

  Baseline, Week 12

Secondary Outcomes (43)

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

  Baseline, Week 2, 4, 8, 12

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

  Baseline, Week 2, 4, 12

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

  Baseline, Week 2, 4, 8, 12

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

  Baseline, Week 12

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

  Baseline up to Week 12

Study Arms (3)

PF-04965842 100 mg

EXPERIMENTAL

Drug: PF-04965842 100 mg

PF-04965842 200 mg

EXPERIMENTAL

Drug: PF-04965842 200 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-04965842 100 mg DRUG

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

PF-04965842 100 mg

PF-04965842 200 mg DRUG

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

PF-04965842 200 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (88)

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, 35209, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

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

San Diego, California, 92123, United States

Location

TCR Medical Corporation

San Diego, California, 92123, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, 33134, United States

Location

Olympian Clinical Research

Largo, Florida, 33770, United States

Location

Forward Clinical Trials, Inc.

Tampa, Florida, 33624, United States

Location

Meridian Clinical Research, LLC

Savannah, Georgia, 31406, United States

Location

NorthShore University HealthSystem Dermatology Clinical Trials Unit

Skokie, Illinois, 60077, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Dawes Fretzin Dermatology Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Henry Ford Medical Center, New Center One

Detroit, Michigan, 48202, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina Investigational Drug Services

Charleston, South Carolina, 29425, United States

Location

MUSC SCTR Research Nexus Clinic and Laboratory

Charleston, South Carolina, 29425, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

The University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Pace Dermatology Associates

Lakewood, Washington, 98499, United States

Location

MultiCare Allenmore Hospital

Tacoma, Washington, 98405, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Pace Dermatology Associates

Tacoma, Washington, 98405, United States

Location

Australian Clinical Research Network (ACRN)

Maroubra, New South Wales, 2035, Australia

Location

Spectrum Medical Imaging

Maroubra, New South Wales, 2035, Australia

Location

Queensland X-Ray

Upper Mount Gravatt, Queensland, 4122, Australia

Location

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 4102, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Skin and Cancer Foundation Inc

Carlton, Victoria, 3053, Australia

Location

Melbourne Radiology Clinic

East Melbourne, Victoria, 3002, Australia

Location

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

The Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Bridge Road Imaging

Richmond, Victoria, 3121, Australia

Location

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

Location

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1, Canada

Location

Dr. Chih-ho Hong Medical Inc

Surrey, British Columbia, V3R 6A7, Canada

Location

University of British Columbia Department of Dermatology and Skin Science

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

York Dermatology Center

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N2, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Lekarna Na Vaclavskem namesti

Kutná Hora, 284 01, Czechia

Location

Kozni ambulance Kutna Hora, s.r.o.

Kutná Hora, 28401, Czechia

Location

Lekarna Fakultni Nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia

Location

Fakultni Nemocnice Ostrava, Kozni oddeleni

Ostrava - Poruba, 70852, Czechia

Location

Sanatorium profesora Arenbergera

Prague, 11000, Czechia

Location

Lekarna U sv. Ignace

Prague, 120 00, Czechia

Location

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

Ústí nad Labem, 40113, Czechia

Location

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

Ústí nad Labem, 40113, Czechia

Location

Universitaetsklinikum Schleswig-Holstein/Campus Luebeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Charité - Universitaetsmedizin Berlin, CCM

Berlin, 10117, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen, Hautklinik

Erlangen, 91054, Germany

Location

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Ludwig-Maximilians-University Munich

Munich, 80337, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Bács-Kiskun Megyei Kórház, Bőr-és nemibeteg Szakrendelés

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

Debrecen, 4032, Hungary

Location

Bacs-Kiskun Megyei Korhaz Kozponti Radiologiai Osztaly

Kecskemét, 6000, Hungary

Location

CRU Hungary Ltd.

Miskolc, 3529, Hungary

Location

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

Pécs, 7632, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, 7632, Hungary

Location

MULTIKLINIKA Salute Sp. z o.o.

Katowice, 40-123, Poland

Location

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

Katowice, 40-282, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Pro Familia Altera Sp. z o.o.

Katowice, 40-648, Poland

Location

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

Lodz, 90-265, Poland

Location

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

Lodz, 90-436, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Wojskowy Instytut Medyczny, Klinika Dermatologiczna

Warsaw, 04-141, Poland

Location

Derriford Hospital, Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, Greater London, NW3 2QG, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, England, S5 7AU, United Kingdom

Location

Sheffield Children's Hospital NHS Foundation Trust

Sheffield, South Yorkshire, S10 2TH, United Kingdom

Location

The Dudley Group NHS Foundation Trust

Dudley, DY1 2HQ, United Kingdom

Location

Related Publications (13)

• 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.

  PMID: 40028832 DERIVED

• 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.

  PMID: 39104653 DERIVED

• 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.

  PMID: 38896380 DERIVED

• 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.

  PMID: 37988255 DERIVED

• 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.

  PMID: 37949351 DERIVED

• 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.

  PMID: 35763326 DERIVED

• 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.

  PMID: 35462428 DERIVED

• 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.

  PMID: 35342978 DERIVED

• 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.

  PMID: 35061234 DERIVED

• 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.

  PMID: 34743361 DERIVED

• 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.

  PMID: 34406619 DERIVED

• 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.

  PMID: 33954933 DERIVED

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

  PMID: 32711801 DERIVED

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: November 17, 2017
• First Posted: November 21, 2017
• Study Start: December 7, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: December 10, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (5); DE (10); CZ (8); US (29); PL (8); CA (12); HU (6); AU (10)