Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
NCT ID: NCT02969018
Last Updated: 2019-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
212 participants
INTERVENTIONAL
2016-12-31
2018-03-31
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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PF-06700841 60 mg followed by 30 mg once daily
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily
PF-06700841
PF-06700841 60 mg followed by 10 mg once daily
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
PF-06700841
PF-06700841 60mg once daily followed by 100mg once weekly
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
PF-06700841
PF-06700841 60mg once daily followed by placebo once daily
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily
PF-06700841
PF-06700841 30mg once daily
4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily
PF-06700841
PF-06700841 30mg once daily followed by 10mg once daily
4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
PF-06700841
PF-06700841 30mg once daily followed by 100mg once weekly
4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
PF-06700841
Placebo
12 weeks once daily placebo
Placebo
Interventions
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PF-06700841
Placebo
Eligibility Criteria
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Inclusion Criteria
* Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
* Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
* Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)
Exclusion Criteria
* Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
* Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
* Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
* Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
* Have undergone treatment with tofacitinib within 3 months of first dose.
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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Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
Rogers, Arkansas, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery
Sacramento, California, United States
Southern California Dermatology
Santa Ana, California, United States
Tower Saint John's Imaging
Santa Monica, California, United States
Clinical Science Institute
Santa Monica, California, United States
Park Avenue Dermatology Administrative Annex
Orange Park, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Rose Radiology
Tampa, Florida, United States
Forward Clinical Trials, Inc
Tampa, Florida, 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
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
The Rockefeller University
New York, New York, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Investigational Drug Services, UNC Hospitals
Chapel Hill, North Carolina, United States
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States
UNC Clinical and Translation Research Center
Chapel Hill, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C
Tulsa, Oklahoma, United States
Health Concepts
Rapid City, South Dakota, United States
Center for Clinical Studies
Houston, Texas, United States
Lee Medical Associates, PA
San Antonio, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
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 Inc.
Waterloo, Ontario, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Centrum Medyczne Enel-Med Przychodnia Grunwaldzka
Gdansk, , Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, , Poland
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
Lodz, , Poland
NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Torun, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
WroMedica s.c.
Wroclaw, , Poland
Countries
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References
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Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
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.
Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.
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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2016-004049-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7931004
Identifier Type: -
Identifier Source: org_study_id
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