Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis

A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM APPLIED ONCE OR TWICE DAILY FOR 12 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Vehicle (Placebo); Drug: PF-06700841

• Study Type: Interventional
• Enrollment (Actual): 344
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research Pty Ltd
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital
• Bulgaria
  • Sofia, Bulgaria, 1431
    • DCC Alexandrovska
  • Sofia, Bulgaria, 1404
    • Center for Skin and Venereal Diseases EOOD - Sofia
  • Sofia, Bulgaria, 1463
    • Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
  • Sofia, Bulgaria, 1756
    • Dermatological Clinic Sofia
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
  • Ontario
    • Cobourg, Ontario, Canada, K9A 4J9
      • Skin Health
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Recherche Sherbrooke Inc.
• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Berlin, Germany, 10789
    • ISA - Interdisciplinary Study Association GmbH
  • Bielefeld, Germany, 33647
    • Klinikum Bielefeld gem.GmbH
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
  • Hamburg, Germany, 22391
    • MENSINGDERMA research GmbH
  • Hamburg, Germany, 22391
    • MVZ Alstermed GmbH
  • Mahlow, Germany, 15831
    • Dermatologische Gemeinschaftspraxis
  • Schwerin, Germany, 19055
    • Klinische Forschung Schwerin GmbH
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem Általános Orvostudományi Kar
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Kecskemet, Hungary, 6000
    • Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
• Japan
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 003-0833
      • Kitago Dermatology Clinic
  • Osaka
    • Kita-ku, Osaka-shi, Osaka, Japan, 531-0072
      • Nakatsuhifuka Clinic
  • Tokyo
    • Minato-ku, Tokyo, Japan, 106-0047
      • Parkside Hiroo Ladies Clinic
    • Ota Ku, Tokyo, Japan, 143-0023
      • Tanpopo Skin Clinic
    • Shinjuku-ku, Tokyo, Japan, 160-0017
      • Samoncho Dermatological Clinic
    • Tachikawa, Tokyo, Japan, 190-0023
      • Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
• Latvia
  • Riga, Latvia, LV-1003
    • Aesthetic dermatology clinic of Prof. J. Kisis
  • Riga, Latvia, LV-1009
    • Health and Aesthetics Ltd
  • Riga, Latvia, LV-1001
    • Riga 1st Hospital
  • Ventspils, Latvia, LV3601
    • Outpatient Clinic Of Ventspils
• Poland
  • Bialystok, Poland, 15-351
    • Zdrowie Osteo-Medic s.c. LiA Racewicz, AiJ Supronik
  • Torun, Poland, 87-100
    • Nasz Lekarz Przychodnie Medyczne
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp. z o.o
  • Wroclaw, Poland, 51-685
    • WroMedica I. Bielicka, A. Strzalkowska s.c.
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Center for Dermatology and Plastic Surgery/CCT
    • Scottsdale, Arizona, United States, 85260
      • Center For Dermatology and Plastic Surgery
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Anaheim, California, United States, 92801
      • California Skin Institute
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • New England Research Associates, LLC
    • Shelton, Connecticut, United States, 06484
      • Dermatology Physicians of Connecticut
  • Florida
    • Clearwater, Florida, United States, 33756
      • Olympian Clinical Research
    • DeLand, Florida, United States, 32720
      • Accel Research Sites - DeLand Clinical Research Unit
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34471
      • MidState Skin Institute
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology, PA
    • Tampa, Florida, United States, 33613
      • Center for Clinical Studies
  • Illinois
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • DS Research
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • DS Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Meridian Clinical Research, LLC
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
  • New York
    • Bayside, New York, United States, 11360
      • Bayside Dermatology Center
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services, PLLC
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, PC
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology Clinical Research
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Institute for Clinical Research, Inc.
    • Cypress, Texas, United States, 77433
      • Studies in Dermatology, LLC
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD. LLP
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Virginia
    • Franklin, Virginia, United States, 23851
      • Summit Clinical Research, LLC
    • Norfolk, Virginia, United States, 23502
      • Virginia Dermatology and Skin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• plaque psoriasis for 6 months
• PGA score mild or moderate
• body surface area (BSA) 2-15%

Exclusion Criteria:

• other skin conditions that would interfere with the evaluation of psoriasis
• history of herpes zoster or simplex
• Infected with Mycobacterium tuberculosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle cream QD; Vehicle cream applied once daily (QD)	Drug: Vehicle (Placebo); Vehicle topical cream
EXPERIMENTAL: PF-06700841 0.1% cream QD; PF-06700841 0.1% cream applied once daily (QD)	Drug: PF-06700841; PF-06700841 topical cream
EXPERIMENTAL: PF-06700841 0.3% cream QD; PF-06700841 0.3% cream applied once daily (QD)	Drug: PF-06700841; PF-06700841 topical cream
EXPERIMENTAL: PF-06700841 1% cream QD; PF-06700841 1% cream applied once daily (QD)	Drug: PF-06700841; PF-06700841 topical cream
EXPERIMENTAL: PF-06700841 3% cream QD; PF-06700841 3% cream applied once daily (QD)	Drug: PF-06700841; PF-06700841 topical cream
EXPERIMENTAL: PF-06700841 0.3% cream BID; PF-06700841 0.3% cream applied twice daily (BID)	Drug: PF-06700841; PF-06700841 topical cream
EXPERIMENTAL: PF-06700841 1% cream BID; PF-06700841 1% cream applied twice daily (BID)	Drug: PF-06700841; PF-06700841 topical cream
PLACEBO_COMPARATOR: Vehicle cream BID; Vehicle cream applied twice daily (BID)	Drug: Vehicle (Placebo); Vehicle topical cream
EXPERIMENTAL: PF-06700841 3% cream BID; PF-06700841 3% cream applied twice daily (BID)	Drug: PF-06700841; PF-06700841 topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, Week 12
Percentage of Participants With 75% Reduction From Baseline in PASI at 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.	Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Change From Baseline in PASI Scores at 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.	Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Change From Baseline in PASI Scores at 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.	Baseline, Week 14 and 16
Percent Change From Baseline in PASI Scores at 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.	Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Percent Change From Baseline in PASI Scores at 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.	Baseline, Week 14 and 16
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at 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.	Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Absolute PP-NRS Score at 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.	Week 14 and 16
Change From Baseline in PP-NRS Score at 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.	Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Change From Baseline in PP-NRS Score at 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.	Baseline, Week 14 and 16
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	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.	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)
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	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.	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)
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	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.	Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16
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	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.	Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs	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.	Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With TEAEs by Severity	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).	Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants Who Discontinued From Study Due to Adverse Events	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.	Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With Laboratory Abnormalities Meeting Specified Criteria	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.	Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data	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.	Post-baseline to Week 6, Post-baseline to Week 12
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data	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.	Post-baseline to Week 12
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on 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]).	Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Forman SB, Pariser DM, Poulin Y, Vincent MS, Gilbert SA, Kieras EM, Qiu R, Yu D, Papacharalambous J, Tehlirian C, Peeva E. TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. J Invest Dermatol. 2020 Dec;140(12):2359-2370.e5. doi: 10.1016/j.jid.2020.03.962. Epub 2020 Apr 18.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2019
• Primary Completion (ACTUAL): April 20, 2021
• Study Completion (ACTUAL): April 20, 2021

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (ACTUAL): February 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: topical; psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; PF-06700841
• Other Study ID Numbers: B7931023; 2018-003051-38 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No