Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOSE-RANGING, STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-04965842 IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
2 other identifiers
interventional
269
5 countries
64
Brief Summary
Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2016
Shorter than P25 for phase_2
64 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
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedResults Posted
Study results publicly available
May 16, 2018
CompletedMay 2, 2019
April 1, 2019
11 months
April 11, 2016
February 23, 2018
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12
The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Baseline and Week 12
Secondary Outcomes (24)
Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12
Baseline and Week 12
Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.
Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16
Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
- +19 more secondary outcomes
Study Arms (5)
Cohort 1
EXPERIMENTAL10 mg of PF-04965842 QD
Cohort 2
EXPERIMENTAL30 mg of PF-04965842 QD
Cohort 3
EXPERIMENTAL100 mg of PF-04965842 QD
Cohort 4
EXPERIMENTAL200 mg of PF-04965842 QD
Cohort 5
PLACEBO COMPARATORplacebo QD
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
- Must have the following atopic dermatitis criteria:
- Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
- Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
- Moderate to severe AD (affected BSA \>=10 %, IGA \>=3, and EASI \>=12 at the screening and baseline visits).
You may not qualify if:
- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
- Infected with hepatitis B or hepatitis C viruses.
- Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Have received any of the following treatment regiments specified in the timeframes outlined below:
- Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.
- Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
- Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (64)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
Huntington Medical Foundation
Pasadena, California, 91105, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274, United States
Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery
Sacramento, California, 95819, United States
TCR Medical Corporation
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
University of Connecticut Health Center (UConn Health)
Farmington, Connecticut, 06032, United States
Olympian Clinical Research
Clearwater, Florida, 33756, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204, United States
Park Avenue Dermatology Administration Annex
Orange Park, Florida, 32073, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida, 32174, United States
Forward Clinical Trials, Inc.
Tampa, Florida, 33624, United States
MedaPhase, Inc.
Newnan, Georgia, 30263, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, 46256, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
DS Research
Louisville, Kentucky, 40241, United States
Shondra L Smith, MD Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605, United States
Somerset Skin Centre
Troy, Michigan, 48084, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
The Dermatology Group, P.C
Verona, New Jersey, 07044, United States
Forest Hills Dermatology Group
Forest Hills, New York, 11375, United States
Sadick Research Group
New York, New York, 10075, United States
Vital Prospects Clinical Research Institute, P.C
Tulsa, Oklahoma, 74136, United States
DermDox Centers for Dermatology
Hazleton, Pennsylvania, 18201, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Virginia Clinical Research,Inc
Norfolk, Virginia, 23502, United States
West End Dermatology Associates
Richmond, Virginia, 23233, United States
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
Australian Clinical Research Network
Sydney, New South Wales, 2035, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fremantle Dermatology
Fremantle, Western Australia, 6160, Australia
North Eastern Health Specialists
Hectorville, South Australia, 5073, Australia
University of British Columbia
Vancouver, British Columbia, V5Z 4E8, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
Research by ICLS
Oakville, Ontario, L6J 7W5, Canada
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B IA5, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
Windsor Clinical Research Inc
Windsor, Ontario, N8W 5L7, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, G1V 4X7, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
ISA GmbH
Berlin, 10789, Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Bacs Kiskun Megyei Korhaz, Bor es Nemibeteggondozo
Kecskemét, 6000, Hungary
CRU Hungary Ltd., MISEK-CRU
Miskolc, 3529, Hungary
Szegedi Tudomanyegyetem SzentGyorgyi Albert Klinikai Kozpont Borgyogyaszati es Allergologiai Klinika
Szeged, 6720, Hungary
Allergo-Derm Bakos Kft.
Szolnok, 5000, Hungary
Related Publications (13)
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: 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: 38896380DERIVEDSchmid-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: 37988255DERIVEDAlexis 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: 37949351DERIVEDGooderham MJ, Girolomoni G, Moore JO, Silverberg JI, Bissonnette R, Forman S, Peeva E, Biswas P, Valdez H, Chan G. Durability of Response to Abrocitinib in Patients with Moderate-to-Severe Atopic Dermatitis After Treatment Discontinuation in a Phase 2b Trial. Dermatol Ther (Heidelb). 2022 Sep;12(9):2077-2085. doi: 10.1007/s13555-022-00764-4. Epub 2022 Aug 7.
PMID: 35933552DERIVEDBlauvelt 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: 35763326DERIVEDStander 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: 35462428DERIVEDWojciechowski 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: 35342978DERIVEDWojciechowski 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: 35061234DERIVEDSimpson 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: 34406619DERIVEDSilverberg 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: 33954933DERIVEDSimpson EL, Wollenberg A, Bissonnette R, Silverberg JI, Papacharalambous J, Zhu L, Zhang W, Beebe JS, Vincent M, Peeva E, Bushmakin AG, Cappelleri JC, Chen L, Sikirica V, Xenakis J. Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. Dermatitis. 2021 Oct 1;32(1S):S53-S61. doi: 10.1097/DER.0000000000000725.
PMID: 33795561DERIVEDGooderham MJ, Forman SB, Bissonnette R, Beebe JS, Zhang W, Banfield C, Zhu L, Papacharalambous J, Vincent MS, Peeva E. Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2019 Dec 1;155(12):1371-1379. doi: 10.1001/jamadermatol.2019.2855.
PMID: 31577341DERIVED
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 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2016
First Posted
May 23, 2016
Study Start
April 1, 2016
Primary Completion
March 1, 2017
Study Completion
April 1, 2017
Last Updated
May 2, 2019
Results First Posted
May 16, 2018
Record last verified: 2019-04
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.