Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

Pfizer212 enrolled

Overview

The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

212

Conditions

Chronic Plaque Psoriasis

Interventions

PF-06700841DRUG

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug) * Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug) * Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug) * Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment) Exclusion Criteria: * Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed * Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis * Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) * Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz). * Have taken Apremilast (Otezla) within 3 months of first dose of study drug. * Have undergone treatment with tofacitinib within 3 months of first dose.

Locations (44)

Outcomes

Primary Outcomes

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Time frame: Baseline (Day 1 pre-dose), Week 12

Secondary Outcomes

Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12

A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Time frame: Week 12

Change From Baseline in PASI Scores at Week 4 by Induction Dose

Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Time frame: Baseline (Day 1 pre-dose), Week 4

Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16

Time frame: Weeks 1, 2, 4, 6, 8, 10, 14, 16

Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Data from ClinicalTrials.gov

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Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA

Rogers, Arkansas, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery

Sacramento, California, United States

Southern California Dermatology

Santa Ana, California, United States

Tower Saint John's Imaging

Santa Monica, California, United States

Clinical Science Institute

Santa Monica, California, United States

Park Avenue Dermatology Administrative Annex

Orange Park, Florida, United States

Park Avenue Dermatology

Orange Park, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

...and 34 more locations

A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16

The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Time frame: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16

Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Time frame: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.

Time frame: From first dose of study treatment (Day 1) up to Week 20

Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs

The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).

Time frame: From first dose of study treatment (Day 1) up to Week 20

Change From Baseline in Blood Lipid Level at Weeks 4 and 12

Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.

Time frame: Baseline (Day 1 pre-dose), Weeks 4 and 12

Number of Participants With Any Post-Baseline Laboratory Test Abnormalities

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio; chemistry (total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, total cholesterol, LDL and HDL cholesterol, triglycerides, calcium, sodium, potassium, chloride, bicarbonate, glucose, creatine kinase, Cystatin C, glomerular filtration rate; urinalysis (pH, urine glucose, ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria, choriogonadotropin beta).

Time frame: From first dose of study treatment (Day 1) up to Week 16

Number of Participants With Post-Baseline Vital Sign Abnormalities

Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) \<50 mmHg; 3) sitting pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (\>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP \>=30 mmHg.

Time frame: From first dose of study treatment (Day 1) up to Week 16

Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities

ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): \>=140 milliseconds (msec), \>=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% change when baseline is \> 200 msec or \>=50% change when baseline is less than or equal to (\<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of \>=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; a change from baseline of 30 to \<60 msec or \>=60 msec.

Time frame: From first dose of study treatment (Day 1) up to Week 16