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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2020-11-26

Brief Summary

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This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06826647 Drug Dose Level 1

Delivered orally for 16 weeks during the Investigational Treatment Period

Group Type EXPERIMENTAL

PF-06826647 or Placebo

Intervention Type DRUG

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

Group Type EXPERIMENTAL

PF-06826647 or Placebo

Intervention Type DRUG

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

Group Type EXPERIMENTAL

PF-06826647 or Placebo

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

PF-06826647 or Placebo

Intervention Type DRUG

Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period

PF-06826647

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

PF-06826647 or Placebo

Intervention Type DRUG

Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period

PF-06826647

Intervention Type DRUG

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

Intervention Type DRUG

PF-06826647

Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female between the ages of 18 and 75 years.
* 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

* Have non-plaque forms of psoriasis.
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Center for Dermatology and Plastic Surgery/CCT

Scottsdale, Arizona, United States

Site Status

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, United States

Site Status

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Kern Research. Inc.

Bakersfield, California, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

Imaging Healthcare Specialists

San Diego, California, United States

Site Status

Medderm Associates Dermatology

San Diego, California, United States

Site Status

University Clinical Trials

San Diego, California, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

MidState Skin Institute

Ocala, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Advanced Diagnostic Group

Orange Park, Florida, United States

Site Status

Park Avenue Dermatology

Orange Park, Florida, United States

Site Status

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Hamilton Research, LLC

Alpharetta, Georgia, United States

Site Status

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, United States

Site Status

Qualmedica Research, LLC

Owensboro, Kentucky, United States

Site Status

Owensboro Dermatology Associates

Owensboro, Kentucky, United States

Site Status

DelRicht Research

Baton Rouge, Louisiana, United States

Site Status

DelRicht Research

Baton Rouge, Louisiana, United States

Site Status

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Site Status

Arlington Research Center, Inc.

Arlington, Texas, United States

Site Status

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Site Status

SKiN Health

Cobourg, Ontario, Canada

Site Status

Dermatrials Research

Hamilton, Ontario, Canada

Site Status

Lynderm Research Inc.

Markham, Ontario, Canada

Site Status

Toronto Research Centre

Toronto, Ontario, Canada

Site Status

K. Papp Clinical Research

Waterloo, Ontario, Canada

Site Status

Centre Radiologique de l'Estrie

Sherbrooke, Quebec, Canada

Site Status

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Site Status

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Site Status

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, Japan

Site Status

Seibo International Catholic Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

Fukuoka University Hospital

Fukuoka, , Japan

Site Status

Tokyo Medical University Hospital

Tokyo, , Japan

Site Status

Malopolskie Centrum Medyczn

Krakow, Lesser Poland Voivodeship, Poland

Site Status

MTZ Clinical Research Sp. z o.o.

Warsaw, Masovian Voivodeship, Poland

Site Status

Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik

Bialystok, Podlaskie Voivodeship, Poland

Site Status

SpecDerm Poznanska Sp. J.

Bialystok, , Poland

Site Status

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, , Poland

Site Status

Pratia MCM Krakow

Krakow, , Poland

Site Status

Tomasz Blicharski Lubelskie Centrum Diagnostyczne

Swidnik, Lubelskie, , Poland

Site Status

Countries

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United States Canada Japan Poland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C2501004

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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