Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
- Registration Number
- NCT02969018
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-06700841 60 mg followed by 30 mg once daily PF-06700841 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily PF-06700841 60mg once daily followed by 100mg once weekly PF-06700841 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly PF-06700841 30mg once daily PF-06700841 4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily PF-06700841 30mg once daily followed by 10mg once daily PF-06700841 4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily PF-06700841 60mg once daily followed by placebo once daily PF-06700841 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily Placebo Placebo 12 weeks once daily placebo PF-06700841 60 mg followed by 10 mg once daily PF-06700841 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily PF-06700841 30mg once daily followed by 100mg once weekly PF-06700841 4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
- Primary Outcome Measures
Name Time Method Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 Baseline (Day 1 pre-dose), 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From first dose of study treatment (Day 1) up to Week 20 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.
Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs From first dose of study treatment (Day 1) up to Week 20 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).
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 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.
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Baseline (Day 1 pre-dose), 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.
Number of Participants With Any Post-Baseline Laboratory Test Abnormalities From first dose of study treatment (Day 1) up to Week 16 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).
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 Baseline (Day 1 pre-dose), Weeks 4 and 12 Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.
Number of Participants With Post-Baseline Vital Sign Abnormalities From first dose of study treatment (Day 1) up to Week 16 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.
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 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.
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Weeks 1, 2, 4, 6, 8, 10, 14, 16 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.
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 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.
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Baseline (Day 1 pre-dose), 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.
Change From Baseline in PASI Scores at Week 4 by Induction Dose Baseline (Day 1 pre-dose), Week 4 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.
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities From first dose of study treatment (Day 1) up to Week 16 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.
Trial Locations
- Locations (44)
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Dawes Fretzin Dermatology Group, LLC
🇺🇸Indianapolis, Indiana, United States
Lee Medical Associates, PA
🇺🇸San Antonio, Texas, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
🇺🇸Rogers, Arkansas, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Centrum Medyczne Enel-Med Przychodnia Grunwaldzka
🇵🇱Gdansk, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
🇵🇱Gdansk, Poland
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Park Avenue Dermatology Administrative Annex
🇺🇸Orange Park, Florida, United States
Southern California Dermatology
🇺🇸Santa Ana, California, United States
Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States
Rose Radiology
🇺🇸Tampa, Florida, United States
Dundee Dermatology
🇺🇸West Dundee, Illinois, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
🇨🇦Quebec, Canada
Skin Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
K.Papp Clinical Research Inc.
🇨🇦Waterloo, Ontario, Canada
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Research by ICLS
🇨🇦Oakville, Ontario, Canada
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
🇵🇱Lodz, Poland
NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
🇵🇱Torun, Poland
MTZ Clinical Research Sp. z o.o.
🇵🇱Warszawa, Poland
WroMedica s.c.
🇵🇱Wroclaw, Poland
The Rockefeller University
🇺🇸New York, New York, United States
Tower Saint John's Imaging
🇺🇸Santa Monica, California, United States
Vital Prospects Clinical Research Institute, P.C
🇺🇸Tulsa, Oklahoma, United States
Forward Clinical Trials, Inc
🇺🇸Tampa, Florida, United States
Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery
🇺🇸Sacramento, California, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
UNC Dermatology and Skin Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Investigational Drug Services, UNC Hospitals
🇺🇸Chapel Hill, North Carolina, United States
UNC Clinical and Translation Research Center
🇺🇸Chapel Hill, North Carolina, United States