A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis
NCT ID: NCT03895372
Last Updated: 2021-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
179 participants
INTERVENTIONAL
2019-06-27
2020-11-26
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
DOUBLE
Study Groups
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PF-06826647 Drug Dose Level 1
Delivered orally for 16 weeks during the Investigational Treatment Period
PF-06826647 or Placebo
Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
PF-06826647 Placebo
Delivered orally for 16 weeks during the Investigational Treatment Period
PF-06826647 or Placebo
Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
PF-06826647 Drug Dose Level 2
Delivered orally for 16 weeks during the Investigational Treatment Period
PF-06826647 or Placebo
Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
PF-06826647 Drug Dose Level 3
Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.
PF-06826647 or Placebo
Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
PF-06826647
Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
PF-06826647 Drug Dose Level 4
Delivered orally for 16 weeks then for 24 weeks in Extension Period.
PF-06826647 or Placebo
Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
PF-06826647
Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
Interventions
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PF-06826647 or Placebo
Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
PF-06826647
Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
Eligibility Criteria
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Inclusion Criteria
* Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.
* Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).
* Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).
Exclusion Criteria
* Drug-induced psoriasis.
* Current active infection.
* Infected with Mycobacterium tuberculosis (TB).
* Have any history of malignancies.
* Require treatment with prohibited concomitant medications(s).
* Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
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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Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States
Center for Dermatology and Plastic Surgery/CCT
Scottsdale, Arizona, United States
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Kern Research. Inc.
Bakersfield, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Imaging Healthcare Specialists
San Diego, California, United States
Medderm Associates Dermatology
San Diego, California, United States
University Clinical Trials
San Diego, California, United States
Renstar Medical Research
Ocala, Florida, United States
MidState Skin Institute
Ocala, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Advanced Diagnostic Group
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
ForCare Clinical Research
Tampa, Florida, United States
Hamilton Research, LLC
Alpharetta, Georgia, United States
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, United States
Qualmedica Research, LLC
Owensboro, Kentucky, United States
Owensboro Dermatology Associates
Owensboro, Kentucky, United States
DelRicht Research
Baton Rouge, Louisiana, United States
DelRicht Research
Baton Rouge, Louisiana, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
SKiN Health
Cobourg, Ontario, Canada
Dermatrials Research
Hamilton, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Centre Radiologique de l'Estrie
Sherbrooke, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan
Seibo International Catholic Hospital
Shinjuku-ku, Tokyo, Japan
Fukuoka University Hospital
Fukuoka, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Malopolskie Centrum Medyczn
Krakow, Lesser Poland Voivodeship, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, Masovian Voivodeship, Poland
Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik
Bialystok, Podlaskie Voivodeship, Poland
SpecDerm Poznanska Sp. J.
Bialystok, , Poland
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
Kielce, , Poland
Pratia MCM Krakow
Krakow, , Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Swidnik, Lubelskie, , Poland
Countries
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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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2018-004669-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C2501004
Identifier Type: -
Identifier Source: org_study_id
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