Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
NCT ID: NCT02780167
Last Updated: 2019-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
269 participants
INTERVENTIONAL
2016-04-30
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
10 mg of PF-04965842 QD
PF-04965842
10 mg of PF-04965842 QD for 12 weeks
Cohort 2
30 mg of PF-04965842 QD
PF-04965842
30 mg of PF-04965842 QD for 12 weeks
Cohort 3
100 mg of PF-04965842 QD
PF-04965842
100 mg of PF-04965842 QD for 12 weeks
Cohort 4
200 mg of PF-04965842 QD
PF-04965842
200 mg of PF-04965842 QD for 12 weeks
Cohort 5
placebo QD
Placebo
Placebo QD for 12 weeks
Interventions
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PF-04965842
10 mg of PF-04965842 QD for 12 weeks
PF-04965842
30 mg of PF-04965842 QD for 12 weeks
PF-04965842
100 mg of PF-04965842 QD for 12 weeks
PF-04965842
200 mg of PF-04965842 QD for 12 weeks
Placebo
Placebo QD for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Must have the following atopic dermatitis criteria:
1. 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.
2. 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.
3. Moderate to severe AD (affected BSA \>=10 %, IGA \>=3, and EASI \>=12 at the screening and baseline visits).
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Huntington Medical Foundation
Pasadena, California, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States
Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery
Sacramento, California, United States
TCR Medical Corporation
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
University of Connecticut Health Center (UConn Health)
Farmington, Connecticut, United States
Olympian Clinical Research
Clearwater, Florida, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States
Park Avenue Dermatology Administration Annex
Orange Park, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida, United States
Forward Clinical Trials, Inc.
Tampa, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Dundee Dermatology
West Dundee, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
DS Research
Louisville, Kentucky, United States
Shondra L Smith, MD Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, United States
Somerset Skin Centre
Troy, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
The Dermatology Group, P.C
Verona, New Jersey, United States
Forest Hills Dermatology Group
Forest Hills, New York, United States
Sadick Research Group
New York, New York, United States
Vital Prospects Clinical Research Institute, P.C
Tulsa, Oklahoma, United States
DermDox Centers for Dermatology
Hazleton, Pennsylvania, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Health Concepts
Rapid City, South Dakota, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Virginia Clinical Research,Inc
Norfolk, Virginia, United States
West End Dermatology Associates
Richmond, Virginia, United States
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Australian Clinical Research Network
Sydney, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
North Eastern Health Specialists
Hectorville, South Australia, , Australia
University of British Columbia
Vancouver, British Columbia, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Research by ICLS
Oakville, Ontario, Canada
Skin Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Windsor Clinical Research Inc
Windsor, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
ISA GmbH
Berlin, , Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Bacs Kiskun Megyei Korhaz, Bor es Nemibeteggondozo
Kecskemét, , Hungary
CRU Hungary Ltd., MISEK-CRU
Miskolc, , Hungary
Szegedi Tudomanyegyetem SzentGyorgyi Albert Klinikai Kozpont Borgyogyaszati es Allergologiai Klinika
Szeged, , Hungary
Allergo-Derm Bakos Kft.
Szolnok, , Hungary
Countries
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References
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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.
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.
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.
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.
Gooderham 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.
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.
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.
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.
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.
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.
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.
Simpson 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.
Gooderham 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2015-005513-72
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7451006
Identifier Type: -
Identifier Source: org_study_id
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