A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03895372
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Japan, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: PF-06826647 Drug Dose Level 1

Delivered orally for 16 weeks during the Investigational Treatment Period

Experimental: PF-06826647 Placebo

Delivered orally for 16 weeks during the Investigational Treatment Period

Experimental: PF-06826647 Drug Dose Level 2

Delivered orally for 16 weeks during the Investigational Treatment Period

Experimental: PF-06826647 Drug Dose Level 3

Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.

Experimental: PF-06826647 Drug Dose Level 4

Delivered orally for 16 weeks then for 24 weeks in Extension Period.

Interventions

Drug: - PF-06826647 or Placebo

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

Drug: - PF-06826647

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Alliance Dermatology and Mohs Center, Phoenix, Arizona

Status

Recruiting

Address

Alliance Dermatology and Mohs Center

Phoenix, Arizona, 85032

Scottsdale, Arizona

Status

Recruiting

Address

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, 85260

Anaheim, California

Status

Recruiting

Address

Anaheim Clinical Trials LLC-Clinical Research

Anaheim, California, 92801

Dynamic Medical Imaging, Anaheim, California

Status

Recruiting

Address

Dynamic Medical Imaging

Anaheim, California, 92801

Kern Allergy and Medical Research, Bakersfield, California

Status

Recruiting

Address

Kern Allergy and Medical Research

Bakersfield, California, 93301

Encinitas, California

Status

Recruiting

Address

California Dermatology & Clinical Research Institute

Encinitas, California, 92024

Medderm Associates Dermatology, San Diego, California

Status

Recruiting

Address

Medderm Associates Dermatology

San Diego, California, 92103

University Clinical Trials, San Diego, California

Status

Recruiting

Address

University Clinical Trials

San Diego, California, 92123

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

MidState Skin Institute, Ocala, Florida

Status

Recruiting

Address

MidState Skin Institute

Ocala, Florida, 34471

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34471

Advanced Diagnostic Group, Orange Park, Florida

Status

Recruiting

Address

Advanced Diagnostic Group

Orange Park, Florida, 32073

Park Avenue Dermatology, Orange Park, Florida

Status

Recruiting

Address

Park Avenue Dermatology

Orange Park, Florida, 32073

Ormond Beach, Florida

Status

Recruiting

Address

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

Ormond Beach, Florida, 32174

ForCare Clinical Research, Tampa, Florida

Status

Recruiting

Address

ForCare Clinical Research

Tampa, Florida, 33613

Hamilton Research, LLC, Alpharetta, Georgia

Status

Recruiting

Address

Hamilton Research, LLC

Alpharetta, Georgia, 30022

Kansas City Dermatology, P.A., Overland Park, Kansas

Status

Recruiting

Address

Kansas City Dermatology, P.A.

Overland Park, Kansas, 66215

Qualmedica Research, LLC, Owensboro, Kentucky

Status

Recruiting

Address

Qualmedica Research, LLC

Owensboro, Kentucky, 42301

DelRicht Research, Baton Rouge, Louisiana

Status

Recruiting

Address

DelRicht Research

Baton Rouge, Louisiana, 70809

Tulsa, Oklahoma

Status

Recruiting

Address

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136

Arlington Research Center, Inc., Arlington, Texas

Status

Recruiting

Address

Arlington Research Center, Inc.

Arlington, Texas, 76011

International Sites

Wiseman Dermatology Research Inc., Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4

SKiN Health, Cobourg, Ontario, Canada

Status

Recruiting

Address

SKiN Health

Cobourg, Ontario, K9A 4J9

Dermatrials Research, Hamilton, Ontario, Canada

Status

Recruiting

Address

Dermatrials Research

Hamilton, Ontario, L8N 1Y2

Lynderm Research Inc., Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research Inc.

Markham, Ontario, L3P 1X2

Toronto Research Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Toronto Research Centre

Toronto, Ontario, M3H 5Y8

K. Papp Clinical Research, Waterloo, Ontario, Canada

Status

Recruiting

Address

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4

Centre Radiologique de l'Estrie, Sherbrooke, Quebec, Canada

Status

Recruiting

Address

Centre Radiologique de l'Estrie

Sherbrooke, Quebec, J1L 0H8

Diex Recherche Sherbrooke Inc., Sherbrooke, Quebec, Canada

Status

Recruiting

Address

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8

Nagoya City University Hospital, Nagoya, Aichi, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya, Aichi, 467-8602

Teikyo University Hospital, Itabashi-ku, Tokyo, Japan

Status

Recruiting

Address

Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606

NTT Medical Center Tokyo, Shinagawa-ku, Tokyo, Japan

Status

Recruiting

Address

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625

Seibo International Catholic Hospital, Shinjuku-ku, Tokyo, Japan

Status

Recruiting

Address

Seibo International Catholic Hospital

Shinjuku-ku, Tokyo, 161-8521

Fukuoka University Hospital, Fukuoka, Japan

Status

Recruiting

Address

Fukuoka University Hospital

Fukuoka, , 814-0180

Tokyo Medical University Hospital, Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical University Hospital

Tokyo, , 160-0023

Bialystok, Poland

Status

Recruiting

Address

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

Bialystok, , 15-351

SpecDerm Poznanska Sp. J., Bialystok, Poland

Status

Recruiting

Address

SpecDerm Poznanska Sp. J.

Bialystok, , 15-375

Kielce, Poland

Status

Recruiting

Address

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, , 25-316

Pratia MCM Krakow, Krakow, Poland

Status

Recruiting

Address

Pratia MCM Krakow

Krakow, , 30-510

Swidnik, Lubelskie, Poland

Status

Recruiting

Address

Tomasz Blicharski Lubelskie Centrum Diagnostyczne

Swidnik, Lubelskie, , 21-040

MTZ Clinical Research Sp. z o.o., Warszawa, Poland

Status

Recruiting

Address

MTZ Clinical Research Sp. z o.o.

Warszawa, , 02-106

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