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Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT02201524
Recruitment Status : Terminated (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)
First Posted : July 28, 2014
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: PF-04965842 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
200mg of PF-04965842 twice daily
 Drug: PF-04965842
Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks
Other Name: JAK1 inhibitor
Experimental: Cohort 2
400mg of PF-04965842 once daily
 Drug: PF-04965842
Subjects will receive 400 mg PF 04965842 daily for 4 weeks
Other Name: JAK1 inhibitor
Experimental: Cohort 3
200mg of PF-04965842 once daily
 Drug: PF-04965842
Subjects will receive 200 mg PF 04965842 daily for 4 weeks
Other Name: JAK1 inhibitor
Placebo Comparator: Cohort 4
Placebo comparator daily
 Other: Placebo
Subjects will receive placebo for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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).

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. 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) ]
    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.

  6. 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 ]
    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.

  7. Change From Baseline in Fasting Lipids at Week 2, 4 and 8 [ Time Frame: Baseline, Week 2, 4, 8 (early termination) ]
    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.

  8. Change From Baseline in Lipid Ratios at Week 2, 4 and 8 [ Time Frame: Baseline, Week 2, 4, 8 (early termination) ]
    The ratio of LDL-C/HDL-C was reported.

  9. 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) ]
    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.

  10. Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values [ Time Frame: Baseline up to Week 8 (early termination) ]
    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.

  11. Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values [ Time Frame: Baseline up to Week 8 (early termination) ]
    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.

  12. 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) ]
    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.

  13. 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) ]
  14. 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) ]
  15. 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) ]
  16. 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) ]
  17. Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate [ Time Frame: Baseline up to Week 8 (early termination) ]
  18. Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline up to Week 8 (early termination) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201524


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02201524    
Other Study ID Numbers: B7451005
JAK-1 FOR PSORIASIS ( Other Identifier: Alias Study Number )
First Posted: July 28, 2014    Key Record Dates
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016
Last Verified: August 2016
Keywords provided by Pfizer:
Phase 2
randomized
double-blind
placebo
plaque
psoriasis
 safety
efficacy
JAK
janus kinase
moderate
severe
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Abrocitinib
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action