Clinical trial NCT03850483: Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
topical
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: 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
timeFrame: Baseline, Week 12
measure: Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
measure: Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Change From Baseline in PASI Scores at Week 14 and 16
timeFrame: Baseline, Week 14 and 16
measure: Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Percent Change From Baseline in PASI Scores at Week 14 and 16
timeFrame: Baseline, Week 14 and 16
measure: Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Absolute PP-NRS Score at Week 14 and 16
timeFrame: Week 14 and 16
measure: Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Change From Baseline in PP-NRS Score at Week 14 and 16
timeFrame: Baseline, Week 14 and 16
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16
measure: 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
timeFrame: Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs
timeFrame: Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
measure: Number of Participants With TEAEs by Severity
timeFrame: Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
measure: Number of Participants Who Discontinued From Study Due to Adverse Events
timeFrame: Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
measure: Number of Participants With Laboratory Abnormalities Meeting Specified Criteria
timeFrame: Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
measure: Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
timeFrame: Post-baseline to Week 6, Post-baseline to Week 12
measure: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
timeFrame: Post-baseline to Week 12
measure: Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
timeFrame: Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery/CCT
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Anaheim
country: United States
facility: California Skin Institute
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Shelton
country: United States
facility: Dermatology Physicians of Connecticut
state: Connecticut
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites - DeLand Clinical Research Unit
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: MidState Skin Institute
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Tampa
country: United States
facility: Center for Clinical Studies
state: Florida
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Clarksville
country: United States
facility: Ds Research
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Bayside
country: United States
facility: Bayside Dermatology Center
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Cypress
country: United States
facility: studies in Dermatology, LLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Franklin
country: United States
facility: Summit Clinical Research, LLC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Dermatology and Skin Cancer Center
state: Virginia
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Sofia
country: Bulgaria
facility: Center for Skin and Venereal Diseases EOOD - Sofia
city: Sofia
country: Bulgaria
facility: DCC Alexandrovska
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
city: Sofia
country: Bulgaria
facility: Dermatological Clinic Sofia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Cobourg
country: Canada
facility: SKiN Health
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Emovis GmbH
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld gem.GmbH
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
city: Hamburg
country: Germany
facility: MENSINGDERMA research GmbH
city: Hamburg
country: Germany
facility: MVZ Alstermed GmbH
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Sapporo-shi
country: Japan
facility: Kitago Dermatology Clinic
state: Hokkaido
city: Kita-ku, Osaka-shi
country: Japan
facility: Nakatsuhifuka Clinic
state: Osaka
city: Minato-ku
country: Japan
facility: Parkside Hiroo Ladies Clinic
state: Tokyo
city: Ota Ku
country: Japan
facility: Tanpopo Skin Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Samoncho Dermatological Clinic
state: Tokyo
city: Tachikawa
country: Japan
facility: Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
state: Tokyo
city: Riga
country: Latvia
facility: Riga 1st Hospital
city: Riga
country: Latvia
facility: Aesthetic dermatology clinic of Prof. J. Kisis
city: Riga
country: Latvia
facility: Health and Aesthetics Ltd
city: Ventspils
country: Latvia
facility: Outpatient Clinic of Ventspils
city: Bialystok
country: Poland
facility: Zdrowie Osteo-Medic s.c. LiA Racewicz, AiJ Supronik
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o
city: Wroclaw
country: Poland
facility: WroMedica I. Bielicka, A. Strzalkowska s.c.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.