Plaque PsoriasisPhase 2NCT02201524
Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
A Phase 2 study testing PF-04965842 in people with Plaque Psoriasis, run by Pfizer at 45 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- PF-04965842
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 45 sitesin 2 countries
- Study dates
- Nov 2014to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.
- Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
- Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
- Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
Who cannot join
- Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis.
- 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.
- 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:
Show all 18Show fewer
- 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).
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States35 sites
Arlington Research Center, Inc.
Arlington, Texas, 76011
Advanced Medical Research, Inc
Atlanta, Georgia, 30342
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 32505
Olympian Clinical Research
Clearwater, Florida, 33756
Westcoast Radiology Services
Clearwater, Florida, 33756
Columbus Dermatology, P.C.
Columbus, Georgia, 31904
Columbus Regional Research Institute
Columbus, Georgia, 31904
Dermatology Treatment & Research Center, PA
Dallas, Texas, 75230
Duke University Medical Center - Shipment Only
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Dermatology Consulting Services
High Point, North Carolina, 27262
Center for Clinical Studies
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, 46256
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Shondra L Smith, MD
Lake Charles, Louisiana, 70605
Dartmouth-Hitchcock Medical Center - Section of Dermatology
Lebanon, New Hampshire, 03756
Dermatology Research Associates
Los Angeles, California, 90045
DS Research
Louisville, Kentucky, 40202
International Dermatology Research, Inc.
Miami, Florida, 33144
Mount Sinai Medical Center
New York, New York, 10029
Virginia Clinical Research
Norfolk, Virginia, 23507
Dermatology Specialists, Inc.
Oceanside, California, 92056
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Park Avenue Dermatology, PA
Orange Park, Florida, 32073
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida, 32174
Huntington Medical Foundation/Specialty Office
Pasadena, California, 91105
Health Concepts
Rapid City, South Dakota, 57702
Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
Rogers, Arkansas, 72758
Clinical Science Institute
Santa Monica, California, 90404
Premier Clinical Research
Spokane, Washington, 99202-1480
Dundee Dermatology
West Dundee, Illinois, 60118
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
Canada10 sites
Co-Medica Research Network Inc.
Courtice, Ontario, L1E 3C3
Dr Isabelle Delorme Inc.
Drummondville, Quebec, J2B 5L4
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
Research by ICLS
Oakville, Ontario, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
The Centre for Dermatology & Cosmetic
Richmond Hill, Ontario, L4B 1A5
Q & T Research Sherbrooke Inc.
Sherbrooke, Quebec, J1J 2G2
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
K.Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
About this study
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 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.
- Conditions
- Plaque Psoriasis
- Being tested
- PF-04965842, Placebo
- Keywords
- Phase 2, randomized, double-blind, placebo, plaque, psoriasis, safety, efficacy, JAK, janus kinase, moderate, severe
- Medical subject headings
- Plaque, Amyloid, Psoriasis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04965842Drug
Also called JAK1 inhibitor
Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks
PF-04965842Drug
Also called JAK1 inhibitor
Subjects will receive 400 mg PF 04965842 daily for 4 weeks
PF-04965842Drug
Also called JAK1 inhibitor
Subjects will receive 200 mg PF 04965842 daily for 4 weeks
PlaceboOther
Subjects will receive placebo for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 200mg of PF-04965842 twice daily Receives: Drug: PF-04965842 |
| Cohort 2 | Experimental | 400mg of PF-04965842 once daily Receives: Drug: PF-04965842 |
| Cohort 3 | Experimental | 200mg of PF-04965842 once daily Receives: Drug: PF-04965842 |
| Cohort 4 | Placebo comparator | Placebo comparator daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4
PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).
Measured: Baseline, Week 4
Secondary outcomes (18)
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8
PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).
Measured: Baseline, Week 1, 2, 3, 5, 6, 8
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 50 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8
PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 75 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 90 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8
The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicating more severity. Participants with response of clear and almost clear were reported. 90 percent confidence intervals were calculated using clopper-pearson (exact) method.
Measured: Week 1, 2, 3, 4, 5, 6, 8
Change From Baseline in Fasting Lipids at Week 2, 4 and 8
Participants were required to fast 9 hours prior to sampling for lipid profile which included following parameters: low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), cholesterol, triglycerides.
Measured: Baseline, Week 2, 4, 8 (early termination)
Change From Baseline in Lipid Ratios at Week 2, 4 and 8
The ratio of LDL-C/HDL-C was reported.
Measured: Baseline, Week 2, 4, 8 (early termination)
Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Reference range for measurements is 0-0.5 mg/dL and lower limit of detection is less than (<) 0.015 mg/dL. Any value <0.015 mg/dL is imputed as 0.0075 mg/dL.
Measured: Baseline, Week 1, 2, 3, 4, 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values
EBV samples were collected and changes from baseline were evaluated by the principal investigator (PI) for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in adverse event (AEs) or required follow-up.
Measured: Baseline up to Week 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values
CMV samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.
Measured: Baseline up to Week 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values
HSV DNA samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.
Measured: Baseline up to Week 8 (early termination)
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate
Measured: Baseline up to Week 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
ECG change data was reported as qualitative results, as per change in planned analysis. It was categorized as: normal; abnormal, not clinically significant or abnormal, clinically significant.
Measured: Baseline up to Week 8 (early termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Study terminated 26 June 2015 due to changes in the drug development portfolio. This study was not terminated for reasons of safety and/or efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201524
- Sponsor's protocol ID
- B7451005
- Other IDs
- JAK-1 FOR PSORIASIS
- Status last verified
- Aug 2016
- First submitted
- 24 Jul 2014
- Last updated
- 5 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.
PubMed 38896380Wojciechowski 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.
PubMed 35342978Wojciechowski 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.
PubMed 35061234
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02201524
- Acronym / sponsor ID
- B7451005
- Conditions
- Plaque Psoriasis
- Keywords
- Phase 2, randomized, double-blind, placebo, plaque, psoriasis, safety, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated 26 June 2015 due to changes in the drug development portfolio. This study was not terminated for reasons of safety and/or efficacy
- Enrolment
- 59 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-04965842200mg of PF-04965842 twice daily |
| Cohort 2 | Experimental | Drug: PF-04965842400mg of PF-04965842 once daily |
| Cohort 3 | Experimental | Drug: PF-04965842200mg of PF-04965842 once daily |
| Cohort 4 | Placebo comparator | Other: PlaceboPlacebo comparator daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.
- Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
- Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
- Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
Key exclusion criteria (18 listed)
- Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis.
- 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.
- Have received any of the following treatment regimens specified in the timeframes outlined below:
- Ustekinumab (Stelara).
- Any experimental therapy for psoriasis or rheumatoid arthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-04965842Also: JAK1 inhibitorSubjects will receive 200 mg PF 04965842 twice daily for 4 weeks | Drug | Cohort 1 |
| PF-04965842Also: JAK1 inhibitorSubjects will receive 400 mg PF 04965842 daily for 4 weeks | Drug | Cohort 2 |
| PF-04965842Also: JAK1 inhibitorSubjects will receive 200 mg PF 04965842 daily for 4 weeks | Drug | Cohort 3 |
| PlaceboSubjects will receive placebo for 4 weeks | Other | Cohort 4 |
Primary outcome
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4
Time frame: Baseline, Week 4
PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).
18 secondary outcomes
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8
Time frame: Baseline, Week 1, 2, 3, 5, 6, 8
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Week 1, 2, 3, 4, 5, 6, 8
Change From Baseline in Fasting Lipids at Week 2, 4 and 8
Time frame: Baseline, Week 2, 4, 8 (early termination)
Change From Baseline in Lipid Ratios at Week 2, 4 and 8
Time frame: Baseline, Week 2, 4, 8 (early termination)
Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values
Time frame: Baseline up to Week 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values
Time frame: Baseline up to Week 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values
Time frame: Baseline up to Week 8 (early termination)
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate
Time frame: Baseline up to Week 8 (early termination)
Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline up to Week 8 (early termination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38896380Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.
- Derived from this study: PubMed 35342978Wojciechowski 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.
- Derived from this study: PubMed 35061234Wojciechowski 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-04965842 in people with Plaque Psoriasis, run by Pfizer at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201524, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.