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
2 other identifiers
interventional
344
10 countries
79
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2019
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2021
CompletedResults Posted
Study results publicly available
June 29, 2022
CompletedJune 29, 2022
June 1, 2022
2 years
February 20, 2019
April 7, 2022
June 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (21)
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
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
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
Change From Baseline in PASI Scores at Week 14 and 16
Baseline, Week 14 and 16
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
- +16 more secondary outcomes
Study Arms (9)
Vehicle cream QD
PLACEBO COMPARATORVehicle cream applied once daily (QD)
PF-06700841 0.1% cream QD
EXPERIMENTALPF-06700841 0.1% cream applied once daily (QD)
PF-06700841 0.3% cream QD
EXPERIMENTALPF-06700841 0.3% cream applied once daily (QD)
PF-06700841 1% cream QD
EXPERIMENTALPF-06700841 1% cream applied once daily (QD)
PF-06700841 3% cream QD
EXPERIMENTALPF-06700841 3% cream applied once daily (QD)
PF-06700841 0.3% cream BID
EXPERIMENTALPF-06700841 0.3% cream applied twice daily (BID)
PF-06700841 1% cream BID
EXPERIMENTALPF-06700841 1% cream applied twice daily (BID)
Vehicle cream BID
PLACEBO COMPARATORVehicle cream applied twice daily (BID)
PF-06700841 3% cream BID
EXPERIMENTALPF-06700841 3% cream applied twice daily (BID)
Interventions
PF-06700841 topical cream
Eligibility Criteria
You may qualify if:
- plaque psoriasis for 6 months
- PGA score mild or moderate
- body surface area (BSA) 2-15%
You may not qualify if:
- other skin conditions that would interfere with the evaluation of psoriasis
- history of herpes zoster or simplex
- Infected with Mycobacterium tuberculosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (79)
Center for Dermatology and Plastic Surgery/CCT
Scottsdale, Arizona, 85260, United States
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, 85260, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
California Skin Institute
Anaheim, California, 92801, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
New England Research Associates, LLC
Bridgeport, Connecticut, 06606, United States
Dermatology Physicians of Connecticut
Shelton, Connecticut, 06484, United States
Olympian Clinical Research
Clearwater, Florida, 33756, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
MidState Skin Institute
Ocala, Florida, 34471, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Park Avenue Dermatology, PA
Orange Park, Florida, 32073, United States
Center for Clinical Studies
Tampa, Florida, 33613, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Ds Research
Clarksville, Indiana, 47129, United States
DS Research
Louisville, Kentucky, 40241, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70808, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Bayside Dermatology Center
Bayside, New York, 11360, United States
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Rivergate Dermatology Clinical Research
Goodlettsville, Tennessee, 37072, United States
Austin Institute for Clinical Research, Inc.
Austin, Texas, 78705, United States
studies in Dermatology, LLC
Cypress, Texas, 77433, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Summit Clinical Research, LLC
Franklin, Virginia, 23851, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502, United States
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Center for Skin and Venereal Diseases EOOD - Sofia
Sofia, 1404, Bulgaria
DCC Alexandrovska
Sofia, 1431, Bulgaria
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
Sofia, 1463, Bulgaria
Dermatological Clinic Sofia
Sofia, 1756, Bulgaria
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
SKiN Health
Cobourg, Ontario, K9A 4J9, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Gentofte Hospital
Hellerup, 2900, Denmark
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Emovis GmbH
Berlin, 10629, Germany
Rothhaar Studien GmbH
Berlin, 10783, Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789, Germany
Klinikum Bielefeld gem.GmbH
Bielefeld, 33647, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, 01307, Germany
MENSINGDERMA research GmbH
Hamburg, 22391, Germany
MVZ Alstermed GmbH
Hamburg, 22391, Germany
Dermatologische Gemeinschaftspraxis
Mahlow, 15831, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, 1085, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
Kecskemét, 6000, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
Kitago Dermatology Clinic
Sapporo, Hokkaido, 003-0833, Japan
Nakatsuhifuka Clinic
Kita-ku, Osaka-shi, Osaka, 531-0072, Japan
Parkside Hiroo Ladies Clinic
Minato-ku, Tokyo, 106-0047, Japan
Tanpopo Skin Clinic
Ōta-ku, Tokyo, 143-0023, Japan
Samoncho Dermatological Clinic
Shinjuku-ku, Tokyo, 160-0017, Japan
Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
Tachikawa, Tokyo, 190-0023, Japan
Riga 1st Hospital
Riga, LV-1001, Latvia
Aesthetic dermatology clinic of Prof. J. Kisis
Riga, LV-1003, Latvia
Health and Aesthetics Ltd
Riga, LV-1009, Latvia
Outpatient Clinic of Ventspils
Ventspils, LV3601, Latvia
Zdrowie Osteo-Medic s.c. LiA Racewicz, AiJ Supronik
Bialystok, 15-351, Poland
Nasz Lekarz Przychodnie Medyczne
Torun, 87-100, Poland
MTZ Clinical Research Sp. z o.o
Warsaw, 02-106, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw, 51-685, Poland
Related Publications (2)
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.
PMID: 32311398BACKGROUNDDraelos ZD, Bushmakin AG, Ghosh P, Xenakis J, Cappelleri JC. Validation of the Peak Pruritus-Numerical Rating Scale in patients with chronic plaque psoriasis: results from a phase 2 study. Int J Dermatol. 2024 Dec;63(12):e375-e382. doi: 10.1111/ijd.17428. Epub 2024 Aug 19.
PMID: 39160651DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2019
First Posted
February 21, 2019
Study Start
April 8, 2019
Primary Completion
April 20, 2021
Study Completion
April 20, 2021
Last Updated
June 29, 2022
Results First Posted
June 29, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
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.