Clinical trial NCT02969018: Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Keywords: plaque psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 212
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: The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
* Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
* Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
* Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:

* Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
* Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
* Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
* Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
* Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
* Have undergone treatment with tofacitinib within 3 months of first dose.

Primary outcomes:
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
timeFrame: Baseline (Day 1 pre-dose), Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
timeFrame: Week 12
measure: Change From Baseline in PASI Scores at Week 4 by Induction Dose
timeFrame: Baseline (Day 1 pre-dose), Week 4
measure: Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16
timeFrame: Weeks 1, 2, 4, 6, 8, 10, 14, 16
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
timeFrame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
timeFrame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
measure: Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16
timeFrame: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16
measure: Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
timeFrame: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study treatment (Day 1) up to Week 20
measure: Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs
timeFrame: From first dose of study treatment (Day 1) up to Week 20
measure: Change From Baseline in Blood Lipid Level at Weeks 4 and 12
timeFrame: Baseline (Day 1 pre-dose), Weeks 4 and 12
measure: Number of Participants With Any Post-Baseline Laboratory Test Abnormalities
timeFrame: From first dose of study treatment (Day 1) up to Week 16
measure: Number of Participants With Post-Baseline Vital Sign Abnormalities
timeFrame: From first dose of study treatment (Day 1) up to Week 16
measure: Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
timeFrame: From first dose of study treatment (Day 1) up to Week 16
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Sacramento
country: United States
facility: Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Santa Monica
country: United States
facility: Tower Saint John's Imaging
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Orange Park
country: United States
facility: Park Avenue Dermatology Administrative Annex
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: Rose Radiology
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials, Inc
state: Florida
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group, LLC
state: Indiana
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: New York
country: United States
facility: The Rockefeller University
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Chapel Hill
country: United States
facility: Investigational Drug Services, UNC Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Dermatology and Skin Cancer Center
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Clinical and Translation Research Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C
state: Oklahoma
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Lee Medical Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Oakville
country: Canada
facility: Research by ICLS
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc.
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
city: Gdansk
country: Poland
facility: Centrum Medyczne Enel-Med Przychodnia Grunwaldzka
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
city: Torun
country: Poland
facility: NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Wroclaw
country: Poland
facility: WroMedica s.c.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
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.
citation: Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.