Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
- Registration Number
- NCT03850483
- Lead Sponsor
- Pfizer
- Brief Summary
This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
- plaque psoriasis for 6 months
- PGA score mild or moderate
- body surface area (BSA) 2-15%
- other skin conditions that would interfere with the evaluation of psoriasis
- history of herpes zoster or simplex
- Infected with Mycobacterium tuberculosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle cream QD Vehicle (Placebo) Vehicle cream applied once daily (QD) PF-06700841 0.1% cream QD PF-06700841 PF-06700841 0.1% cream applied once daily (QD) PF-06700841 0.3% cream QD PF-06700841 PF-06700841 0.3% cream applied once daily (QD) PF-06700841 0.3% cream BID PF-06700841 PF-06700841 0.3% cream applied twice daily (BID) Vehicle cream BID Vehicle (Placebo) Vehicle cream applied twice daily (BID) PF-06700841 1% cream BID PF-06700841 PF-06700841 1% cream applied twice daily (BID) PF-06700841 1% cream QD PF-06700841 PF-06700841 1% cream applied once daily (QD) PF-06700841 3% cream QD PF-06700841 PF-06700841 3% cream applied once daily (QD) PF-06700841 3% cream BID PF-06700841 PF-06700841 3% cream applied twice daily (BID)
- Primary Outcome Measures
Name Time Method Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 Baseline, Week 12 The Psoriasis Area and Severity Index (PASI) score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected body surface area (BSA) from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
- Secondary Outcome Measures
Name Time Method Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2 Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET) PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2 Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET) PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16 Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16 PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity.
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. Treatment emergent AEs (TEAEs) were events that occurred between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
Number of Participants With TEAEs by Severity Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Number of Participants Who Discontinued From Study Due to Adverse Events Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Number of Participants With Laboratory Abnormalities Meeting Specified Criteria Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) Bilirubin: greater than (\>) 1.5\* upper limit normal (ULN); aspartate aminotransferase, alanine aminotransferase: \>2.5\*ULN; creatinine, cystatin C: \>1.3\*ULN; creatine kinase: \>2.0\*ULN; glomerular filtration rate (GFR) CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Equat: less than (\<) 60 milliliter (mL)/minute (min)/1.73 meter(m)\^2, greater than or equal to (\>=) 30% decrease from baseline; GFR: \<60 mL/min/1.73m\^2.
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12 Baseline, Week 1, 2, 4, 6, 8, 10 and 12 Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
Absolute PP-NRS Score at Week 14 and 16 Week 14 and 16 Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12 Baseline, Week 1, 2, 4, 6, 8, 10 and 12 Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
Change From Baseline in PP-NRS Score at Week 14 and 16 Baseline, Week 14 and 16 Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12 Baseline, Week 12 PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity.
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 Baseline, Week 1, 2, 4, 6, 8, 10 and 12 The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Change From Baseline in PASI Scores at Week 14 and 16 Baseline, Week 14 and 16 The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 Baseline, Week 1, 2, 4, 6, 8, 10 and 12 The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Percent Change From Baseline in PASI Scores at Week 14 and 16 Baseline, Week 14 and 16 The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data Post-baseline to Week 6, Post-baseline to Week 12 Following were ECG criteria used for categorical summary:1) PR interval: percentage change \>=25/50%, QRS interval: value \>140 msec, and QT interval corrected using the Fridericia's formula (QTcF): 450 msec \< value less than equal to (\<=) 480 and 30 \< change \<=60.
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data Post-baseline to Week 12 Following were the vital signs criteria: 1) Pulse rate: value \<40 beats per min (bpm), value \>120 bpm; 2) Sitting diastolic blood pressure (DBP): value \<50 mmHg; change \>=20 mmHg increase; change \>=20 mmHg decrease; 3) Sitting systolic blood pressure (SBP): value \<90 mmHg, change \>=30 mmHg increase, change \>=30 mmHg decrease; 4) Supine DBP: value \<50 mmHg, change \>=20 mmHg increase, change \>=20 mmHg decrease; 5) Supine SBP: value \<90 mmHg, change \>=30 mmHg increase, change \>=30 mmHg decrease.
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 At the site of study drug application, skin tolerability was assessed for non-lesional skin surrounding the plaques on a scale from 0 to 4. Grade 0= none (no evidence of local intolerance), Grade 1= mild (minimal erythema and/or edema, slight glazed appearance), Grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology), Grade 3= severe, reported as AE (erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent \[if still in place\]), Grade 4= very severe, reported as AE (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent \[if still in place\]).
Trial Locations
- Locations (77)
Tanpopo Skin Clinic
🇯🇵Ota Ku, Tokyo, Japan
Aesthetic dermatology clinic of Prof. J. Kisis
🇱🇻Riga, Latvia
Health and Aesthetics Ltd
🇱🇻Riga, Latvia
MTZ Clinical Research Sp. z o.o
🇵🇱Warszawa, Poland
Outpatient Clinic of Ventspils
🇱🇻Ventspils, Latvia
Zdrowie Osteo-Medic s.c. LiA Racewicz, AiJ Supronik
🇵🇱Bialystok, Poland
Diex Recherche Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
California Skin Institute
🇺🇸Anaheim, California, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Vital Prospects Clinical Research Institute, PC
🇺🇸Tulsa, Oklahoma, United States
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
Veracity Clinical Research Pty Ltd
🇦🇺Woolloongabba, Queensland, Australia
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
DCC Alexandrovska
🇧🇬Sofia, Bulgaria
Dermatological Clinic Sofia
🇧🇬Sofia, Bulgaria
ISA - Interdisciplinary Study Association GmbH
🇩🇪Berlin, Germany
Klinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
Emovis GmbH
🇩🇪Berlin, Germany
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
🇭🇺Budapest, Hungary
Dermatologische Gemeinschaftspraxis
🇩🇪Mahlow, Germany
Klinikum Bielefeld gem.GmbH
🇩🇪Bielefeld, Germany
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
Rothhaar Studien GmbH
🇩🇪Berlin, Germany
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
Parkside Hiroo Ladies Clinic
🇯🇵Minato-ku, Tokyo, Japan
Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
🇯🇵Tachikawa, Tokyo, Japan
Riga 1st Hospital
🇱🇻Riga, Latvia
WroMedica I. Bielicka, A. Strzalkowska s.c.
🇵🇱Wroclaw, Poland
Nakatsuhifuka Clinic
🇯🇵Kita-ku, Osaka-shi, Osaka, Japan
MVZ Alstermed GmbH
🇩🇪Hamburg, Germany
Center for Clinical Studies, LTD. LLP
🇺🇸Houston, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Center for Dermatology and Plastic Surgery
🇺🇸Scottsdale, Arizona, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
New England Research Associates, LLC
🇺🇸Bridgeport, Connecticut, United States
Accel Research Sites - DeLand Clinical Research Unit
🇺🇸DeLand, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
MidState Skin Institute
🇺🇸Ocala, Florida, United States
Park Avenue Dermatology, PA
🇺🇸Orange Park, Florida, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Dundee Dermatology
🇺🇸West Dundee, Illinois, United States
Ds Research
🇺🇸Clarksville, Indiana, United States
Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
M3 Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Summit Clinical Research, LLC
🇺🇸Franklin, Virginia, United States
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
SKiN Health
🇨🇦Cobourg, Ontario, Canada
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada
Gentofte Hospital
🇩🇰Hellerup, Denmark
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
🇩🇪Dresden, Germany
MENSINGDERMA research GmbH
🇩🇪Hamburg, Germany
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
🇭🇺Kecskemet, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Samoncho Dermatological Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Kitago Dermatology Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Rivergate Dermatology Clinical Research
🇺🇸Goodlettsville, Tennessee, United States
Dermatology Physicians of Connecticut
🇺🇸Shelton, Connecticut, United States
Olympian Clinical Research
🇺🇸Clearwater, Florida, United States
Meridian Clinical Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Bayside Dermatology Center
🇺🇸Bayside, New York, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Virginia Dermatology and Skin Cancer Center
🇺🇸Norfolk, Virginia, United States
Dermatology Consulting Services, PLLC
🇺🇸High Point, North Carolina, United States
studies in Dermatology, LLC
🇺🇸Cypress, Texas, United States
Center for Skin and Venereal Diseases EOOD - Sofia
🇧🇬Sofia, Bulgaria
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
🇧🇬Sofia, Bulgaria
DS Research
🇺🇸Louisville, Kentucky, United States
Nasz Lekarz Przychodnie Medyczne
🇵🇱Torun, Poland
Austin Institute for Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Center for Dermatology and Plastic Surgery/CCT
🇺🇸Scottsdale, Arizona, United States
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia