Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
NCT ID: NCT02201524
Last Updated: 2016-10-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
59 participants
INTERVENTIONAL
2014-11-30
2015-09-30
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
200mg of PF-04965842 twice daily
PF-04965842
Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks
Cohort 2
400mg of PF-04965842 once daily
PF-04965842
Subjects will receive 400 mg PF 04965842 daily for 4 weeks
Cohort 3
200mg of PF-04965842 once daily
PF-04965842
Subjects will receive 200 mg PF 04965842 daily for 4 weeks
Cohort 4
Placebo comparator daily
Placebo
Subjects will receive placebo for 4 weeks
Interventions
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PF-04965842
Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks
PF-04965842
Subjects will receive 400 mg PF 04965842 daily for 4 weeks
PF-04965842
Subjects will receive 200 mg PF 04965842 daily for 4 weeks
Placebo
Subjects will receive placebo for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
Exclusion Criteria
2. 3\. Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
3. Have received any of the following treatment regimens specified in the timeframes outlined below:
Within 9 months of first dose of study drug:
• Ustekinumab (Stelara).
Within 12 weeks of first dose of study drug:
• Any experimental therapy for psoriasis or rheumatoid arthritis.
Within 4 8 weeks of first dose of study drug:
* Biologic therapies for psoriasis have discontinuation periods determined from approximately 5x half life of the respective biologic:
* 4 weeks: etanercept (Enbrel).
* 8 weeks: infliximab (Remicade), adalimumab (Humira).
Within 4 weeks of first dose of study drug:
* Systemic treatments other than biologics that could affect psoriasis (eg, oral or injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine).
* Phototherapy and psoralen plus ultraviolet A therapy (PUVA).
* Other - intramuscular gold, immunization with any live virus vaccination (eg, FluMist), herbal medications.
Within 2 weeks of first dose of study drug:
* Topical treatments that could affect psoriasis (eg, corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids).
* Phototherapy with ultraviolet B (UVB) (narrowband or broadband).
18 Years
65 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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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
Rogers, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Dermatology Specialists, Inc.
Oceanside, California, United States
Huntington Medical Foundation/Specialty Office
Pasadena, California, United States
Clinical Science Institute
Santa Monica, California, United States
Olympian Clinical Research
Clearwater, Florida, United States
Westcoast Radiology Services
Clearwater, Florida, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Park Avenue Dermatology, PA
Orange Park, Florida, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida, United States
Advanced Medical Research, Inc
Atlanta, Georgia, United States
Columbus Dermatology, P.C.
Columbus, Georgia, United States
Columbus Regional Research Institute
Columbus, 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
DS Research
Louisville, Kentucky, United States
Shondra L Smith, MD
Lake Charles, Louisiana, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Dartmouth-Hitchcock Medical Center - Section of Dermatology
Lebanon, New Hampshire, United States
Mount Sinai Medical Center
New York, New York, United States
Duke University Medical Center - Shipment Only
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Health Concepts
Rapid City, South Dakota, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Dermatology Treatment & Research Center, PA
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Enverus Medical Research
Surrey, British Columbia, Canada
Co-Medica Research Network Inc.
Courtice, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Research by ICLS
Oakville, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology & Cosmetic
Richmond Hill, Ontario, Canada
K.Papp Clinical Research Inc.
Waterloo, Ontario, Canada
Dr Isabelle Delorme Inc.
Drummondville, Quebec, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Q & T Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Countries
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References
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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.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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JAK-1 FOR PSORIASIS
Identifier Type: OTHER
Identifier Source: secondary_id
B7451005
Identifier Type: -
Identifier Source: org_study_id
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