Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
NCT ID: NCT03850483
Last Updated: 2022-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
344 participants
INTERVENTIONAL
2019-04-08
2021-04-20
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
QUADRUPLE
Study Groups
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Vehicle cream QD
Vehicle cream applied once daily (QD)
Vehicle (Placebo)
Vehicle topical cream
PF-06700841 0.1% cream QD
PF-06700841 0.1% cream applied once daily (QD)
PF-06700841
PF-06700841 topical cream
PF-06700841 0.3% cream QD
PF-06700841 0.3% cream applied once daily (QD)
PF-06700841
PF-06700841 topical cream
PF-06700841 1% cream QD
PF-06700841 1% cream applied once daily (QD)
PF-06700841
PF-06700841 topical cream
PF-06700841 3% cream QD
PF-06700841 3% cream applied once daily (QD)
PF-06700841
PF-06700841 topical cream
PF-06700841 0.3% cream BID
PF-06700841 0.3% cream applied twice daily (BID)
PF-06700841
PF-06700841 topical cream
PF-06700841 1% cream BID
PF-06700841 1% cream applied twice daily (BID)
PF-06700841
PF-06700841 topical cream
Vehicle cream BID
Vehicle cream applied twice daily (BID)
Vehicle (Placebo)
Vehicle topical cream
PF-06700841 3% cream BID
PF-06700841 3% cream applied twice daily (BID)
PF-06700841
PF-06700841 topical cream
Interventions
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PF-06700841
PF-06700841 topical cream
Vehicle (Placebo)
Vehicle topical cream
Eligibility Criteria
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Inclusion Criteria
* PGA score mild or moderate
* body surface area (BSA) 2-15%
Exclusion Criteria
* history of herpes zoster or simplex
* Infected with Mycobacterium tuberculosis
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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Center for Dermatology and Plastic Surgery/CCT
Scottsdale, Arizona, United States
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
California Skin Institute
Anaheim, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology
Fountain Valley, California, United States
Clinical Science Institute
Santa Monica, California, United States
New England Research Associates, LLC
Bridgeport, Connecticut, United States
Dermatology Physicians of Connecticut
Shelton, Connecticut, United States
Olympian Clinical Research
Clearwater, Florida, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
MidState Skin Institute
Ocala, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Park Avenue Dermatology, PA
Orange Park, Florida, United States
Center for Clinical Studies
Tampa, Florida, United States
Dundee Dermatology
West Dundee, Illinois, United States
Ds Research
Clarksville, Indiana, United States
DS Research
Louisville, Kentucky, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Hassman Research Institute
Berlin, New Jersey, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Bayside Dermatology Center
Bayside, New York, United States
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Health Concepts
Rapid City, South Dakota, United States
Rivergate Dermatology Clinical Research
Goodlettsville, Tennessee, United States
Austin Institute for Clinical Research, Inc.
Austin, Texas, United States
studies in Dermatology, LLC
Cypress, Texas, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Summit Clinical Research, LLC
Franklin, Virginia, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, United States
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Center for Skin and Venereal Diseases EOOD - Sofia
Sofia, , Bulgaria
DCC Alexandrovska
Sofia, , Bulgaria
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
Sofia, , Bulgaria
Dermatological Clinic Sofia
Sofia, , Bulgaria
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
SKiN Health
Cobourg, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Gentofte Hospital
Hellerup, , Denmark
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Emovis GmbH
Berlin, , Germany
Rothhaar Studien GmbH
Berlin, , Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Klinikum Bielefeld gem.GmbH
Bielefeld, , Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, , Germany
MENSINGDERMA research GmbH
Hamburg, , Germany
MVZ Alstermed GmbH
Hamburg, , Germany
Dermatologische Gemeinschaftspraxis
Mahlow, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
Kecskemét, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Kitago Dermatology Clinic
Sapporo, Hokkaido, Japan
Nakatsuhifuka Clinic
Kita-ku, Osaka-shi, Osaka, Japan
Parkside Hiroo Ladies Clinic
Minato-ku, Tokyo, Japan
Tanpopo Skin Clinic
Ōta-ku, Tokyo, Japan
Samoncho Dermatological Clinic
Shinjuku-ku, Tokyo, Japan
Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
Tachikawa, Tokyo, Japan
Riga 1st Hospital
Riga, , Latvia
Aesthetic dermatology clinic of Prof. J. Kisis
Riga, , Latvia
Health and Aesthetics Ltd
Riga, , Latvia
Outpatient Clinic of Ventspils
Ventspils, , Latvia
Zdrowie Osteo-Medic s.c. LiA Racewicz, AiJ Supronik
Bialystok, , Poland
Nasz Lekarz Przychodnie Medyczne
Torun, , Poland
MTZ Clinical Research Sp. z o.o
Warsaw, , Poland
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw, , Poland
Countries
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References
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Forman SB, Pariser DM, Poulin Y, Vincent MS, Gilbert SA, Kieras EM, Qiu R, Yu D, Papacharalambous J, Tehlirian C, Peeva E. TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. J Invest Dermatol. 2020 Dec;140(12):2359-2370.e5. doi: 10.1016/j.jid.2020.03.962. Epub 2020 Apr 18.
Draelos ZD, Bushmakin AG, Ghosh P, Xenakis J, Cappelleri JC. Validation of the Peak Pruritus-Numerical Rating Scale in patients with chronic plaque psoriasis: results from a phase 2 study. Int J Dermatol. 2024 Dec;63(12):e375-e382. doi: 10.1111/ijd.17428. Epub 2024 Aug 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-003051-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7931023
Identifier Type: -
Identifier Source: org_study_id
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