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

• ClinicalTrials.gov Identifier: NCT03850483
• Recruitment Status: Completed
• First Posted: February 21, 2019
• Results First Posted: June 29, 2022
• Last Update Posted: June 29, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: PF-06700841; Drug: Vehicle (Placebo)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 344 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: April 8, 2019
• Actual Primary Completion Date: April 20, 2021
• Actual Study Completion Date: April 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 [ Time Frame: 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 :

1. 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 [ Time Frame: 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.
2. Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 [ Time Frame: 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.
3. Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 [ Time Frame: 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.
4. Change From Baseline in PASI Scores at Week 14 and 16 [ Time Frame: 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.
5. Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 [ Time Frame: 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.
6. Percent Change From Baseline in PASI Scores at Week 14 and 16 [ Time Frame: 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.
7. Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12 [ Time Frame: 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.
8. Absolute PP-NRS Score at Week 14 and 16 [ Time Frame: 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.
9. Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12 [ Time Frame: 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.
10. Change From Baseline in PP-NRS Score at Week 14 and 16 [ Time Frame: 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.
11. 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 [ Time Frame: 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.
12. 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 [ Time Frame: 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.
13. 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 [ Time Frame: 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.
14. 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 [ Time Frame: 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.
15. Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs [ Time Frame: 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.
16. Number of Participants With TEAEs by Severity [ Time Frame: 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).
17. Number of Participants Who Discontinued From Study Due to Adverse Events [ Time Frame: 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.
18. Number of Participants With Laboratory Abnormalities Meeting Specified Criteria [ Time Frame: 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.
19. Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data [ Time Frame: 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.
20. Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data [ Time Frame: 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.
21. Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 [ Time Frame: 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]).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Center for Dermatology and Plastic Surgery/CCT

Scottsdale, Arizona, United States, 85260

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, United States, 85260

United States, Arkansas

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States, 71913

United States, California

Anaheim Clinical Trials, LLC

Anaheim, California, United States, 92801

California Skin Institute

Anaheim, California, United States, 92801

California Dermatology & Clinical Research Institute

Encinitas, California, United States, 92024

First OC Dermatology

Fountain Valley, California, United States, 92708

Clinical Science Institute

Santa Monica, California, United States, 90404

United States, Connecticut

New England Research Associates, LLC

Bridgeport, Connecticut, United States, 06606

Dermatology Physicians of Connecticut

Shelton, Connecticut, United States, 06484

United States, Florida

Olympian Clinical Research

Clearwater, Florida, United States, 33756

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States, 32720

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States, 32216

Renstar Medical Research

Ocala, Florida, United States, 34470

MidState Skin Institute

Ocala, Florida, United States, 34471

Renstar Medical Research

Ocala, Florida, United States, 34471

Park Avenue Dermatology, PA

Orange Park, Florida, United States, 32073

Center for Clinical Studies

Tampa, Florida, United States, 33613

United States, Illinois

Dundee Dermatology

West Dundee, Illinois, United States, 60118

United States, Indiana

Ds Research

Clarksville, Indiana, United States, 47129

United States, Kentucky

DS Research

Louisville, Kentucky, United States, 40241

United States, Louisiana

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States, 70808

United States, Missouri

MediSearch Clinical Trials

Saint Joseph, Missouri, United States, 64506

United States, New Jersey

Hassman Research Institute

Berlin, New Jersey, United States, 08009

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States, 08520

United States, New York

Bayside Dermatology Center

Bayside, New York, United States, 11360

United States, North Carolina

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States, 27262

M3 Wake Research, Inc.

Raleigh, North Carolina, United States, 27612

United States, Oklahoma

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States, 74136

United States, South Dakota

Health Concepts

Rapid City, South Dakota, United States, 57702

United States, Tennessee

Rivergate Dermatology Clinical Research

Goodlettsville, Tennessee, United States, 37072

United States, Texas

Austin Institute for Clinical Research, Inc.

Austin, Texas, United States, 78705

studies in Dermatology, LLC

Cypress, Texas, United States, 77433

Center for Clinical Studies, LTD. LLP

Houston, Texas, United States, 77004

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

Center for Clinical Studies

Webster, Texas, United States, 77598

United States, Virginia

Summit Clinical Research, LLC

Franklin, Virginia, United States, 23851

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, United States, 23502

Australia, Queensland

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Emeritus Research

Camberwell, Victoria, Australia, 3124

Sinclair Dermatology

East Melbourne, Victoria, Australia, 3002

Cabrini Hospital

Malvern, Victoria, Australia, 3144

Bulgaria

Center for Skin and Venereal Diseases EOOD - Sofia

Sofia, Bulgaria, 1404

DCC Alexandrovska

Sofia, Bulgaria, 1431

Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD

Sofia, Bulgaria, 1463

Dermatological Clinic Sofia

Sofia, Bulgaria, 1756

Canada, Manitoba

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada, R3M 3Z4

Canada, Ontario

SKiN Health

Cobourg, Ontario, Canada, K9A 4J9

Canada, Quebec

Innovaderm Research Inc.

Montreal, Quebec, Canada, H2X 2V1

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada, J1L 0H8

Denmark

Gentofte Hospital

Hellerup, Denmark, 2900

Germany

Fachklinik Bad Bentheim

Bad Bentheim, Germany, 48455

Emovis GmbH

Berlin, Germany, 10629

Rothhaar Studien GmbH

Berlin, Germany, 10783

ISA - Interdisciplinary Study Association GmbH

Berlin, Germany, 10789

Klinikum Bielefeld gem.GmbH

Bielefeld, Germany, 33647

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Germany, 01307

MENSINGDERMA research GmbH

Hamburg, Germany, 22391

MVZ Alstermed GmbH

Hamburg, Germany, 22391

Dermatologische Gemeinschaftspraxis

Mahlow, Germany, 15831

Klinische Forschung Schwerin GmbH

Schwerin, Germany, 19055

Hungary

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, Hungary, 1085

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

Kecskemet, Hungary, 6000

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Hungary, 6720

Japan

Kitago Dermatology Clinic

Sapporo-shi, Hokkaido, Japan, 003-0833

Nakatsuhifuka Clinic

Kita-ku, Osaka-shi, Osaka, Japan, 531-0072

Parkside Hiroo Ladies Clinic

Minato-ku, Tokyo, Japan, 106-0047

Tanpopo Skin Clinic

Ota Ku, Tokyo, Japan, 143-0023

Samoncho Dermatological Clinic

Shinjuku-ku, Tokyo, Japan, 160-0017

Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

Tachikawa, Tokyo, Japan, 190-0023

Latvia

Riga 1st Hospital

Riga, Latvia, LV-1001

Aesthetic dermatology clinic of Prof. J. Kisis

Riga, Latvia, LV-1003

Health and Aesthetics Ltd

Riga, Latvia, LV-1009

Outpatient Clinic of Ventspils

Ventspils, Latvia, LV3601

Poland

Zdrowie Osteo-Medic s.c. LiA Racewicz, AiJ Supronik

Bialystok, Poland, 15-351

Nasz Lekarz Przychodnie Medyczne

Torun, Poland, 87-100

MTZ Clinical Research Sp. z o.o

Warszawa, Poland, 02-106

WroMedica I. Bielicka, A. Strzalkowska s.c.

Wroclaw, Poland, 51-685

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] April 20, 2020

Statistical Analysis Plan  [PDF] May 4, 2021

More Information

Additional Information:

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

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03850483
• Other Study ID Numbers: B7931023; 2018-003051-38 ( EudraCT Number )
• First Posted: February 21, 2019
• Results First Posted: June 29, 2022
• Last Update Posted: June 29, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

psoriasis; topical

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; PF-06700841; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action