Clinical trial NCT03895372: A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis
Official title: A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
timeFrame: From Week 16 to Week 40
measure: Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
timeFrame: From Week 16 to Week 40
measure: Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
timeFrame: From Week 16 to Week 40
measure: Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
timeFrame: From Week 16 to Week 40
measure: Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
timeFrame: From Week 16 to Week 40
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
timeFrame: From Week 16 to Week 40
measure: Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
timeFrame: From Week 16 to Week 40
Secondary outcomes:
measure: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
measure: Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16.
measure: Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
timeFrame: Baseline up to Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery/CCT
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Bakersfield
country: United States
facility: Kern Research. Inc.
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: San Diego
country: United States
facility: Imaging Healthcare Specialists
state: California
city: San Diego
country: United States
facility: Medderm Associates Dermatology
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: MidState Skin Institute
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orange Park
country: United States
facility: Advanced Diagnostic Group
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida d/b/a Ameriderm Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research, LLC
state: Georgia
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas, LLC
state: Kansas
city: Owensboro
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Dermatology Associates
state: Kentucky
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Cobourg
country: Canada
facility: SKiN Health
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre Radiologique de l'Estrie
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Seibo International Catholic Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczn
state: Malopolskie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
state: Mazowieckie
city: Bialystok
country: Poland
facility: Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik
state: Podlaskie
city: Bialystok
country: Poland
facility: SpecDerm Poznanska Sp. J.
city: Kielce
country: Poland
facility: Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Swidnik, Lubelskie
country: Poland
facility: Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: