Clinical trial NCT02201524: Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: Phase 2
randomized
double-blind
placebo
plaque
psoriasis
safety
efficacy
JAK
janus kinase
moderate
severe
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.


Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.
2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).

Exclusion Criteria:

1. Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis.
2. 3. Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
3. Have received any of the following treatment regimens specified in the timeframes outlined below:

Within 9 months of first dose of study drug:

• Ustekinumab (Stelara).

Within 12 weeks of first dose of study drug:

• Any experimental therapy for psoriasis or rheumatoid arthritis.

Within 4 8 weeks of first dose of study drug:

* Biologic therapies for psoriasis have discontinuation periods determined from approximately 5x half life of the respective biologic:
* 4 weeks: etanercept (Enbrel).
* 8 weeks: infliximab (Remicade), adalimumab (Humira).

Within 4 weeks of first dose of study drug:

* Systemic treatments other than biologics that could affect psoriasis (eg, oral or injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine).
* Phototherapy and psoralen plus ultraviolet A therapy (PUVA).
* Other - intramuscular gold, immunization with any live virus vaccination (eg, FluMist), herbal medications.

Within 2 weeks of first dose of study drug:

* Topical treatments that could affect psoriasis (eg, corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids).
* Phototherapy with ultraviolet B (UVB) (narrowband or broadband).

Primary outcomes:
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
measure: Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8
timeFrame: Baseline, Week 1, 2, 3, 5, 6, 8
measure: Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
measure: Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
measure: Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
measure: Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8
timeFrame: Week 1, 2, 3, 4, 5, 6, 8
measure: Change From Baseline in Fasting Lipids at Week 2, 4 and 8
timeFrame: Baseline, Week 2, 4, 8 (early termination)
measure: Change From Baseline in Lipid Ratios at Week 2, 4 and 8
timeFrame: Baseline, Week 2, 4, 8 (early termination)
measure: Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 8 (early termination)
measure: Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values
timeFrame: Baseline up to Week 8 (early termination)
measure: Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values
timeFrame: Baseline up to Week 8 (early termination)
measure: Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values
timeFrame: Baseline up to Week 8 (early termination)
measure: Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
measure: Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
measure: Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
measure: Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
measure: Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate
timeFrame: Baseline up to Week 8 (early termination)
measure: Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
timeFrame: Baseline up to Week 8 (early termination)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: Pasadena
country: United States
facility: Huntington Medical Foundation/Specialty Office
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Westcoast Radiology Services
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida d/b/a Ameriderm Research
state: Florida
city: Atlanta
country: United States
facility: Advanced Medical Research, Inc
state: Georgia
city: Columbus
country: United States
facility: Columbus Dermatology, P.C.
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
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: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Lake Charles
country: United States
facility: Shondra L Smith, MD
state: Louisiana
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center - Section of Dermatology
state: New Hampshire
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center - Shipment Only
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center, PA
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Courtice
country: Canada
facility: Co-Medica Research Network Inc.
state: Ontario
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 & Cosmetic
state: Ontario
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc.
state: Ontario
city: Drummondville
country: Canada
facility: Dr Isabelle Delorme Inc.
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Q & T Research Sherbrooke Inc.
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.
citation: Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.