Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: PF-04965842; PF-04965842; PF-04965842; Placebo
Intervention description: Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks; Subjects will receive 400 mg PF 04965842 daily for 4 weeks; Subjects will receive 200 mg PF 04965842 daily for 4 weeks; Subjects will receive placebo for 4 weeks
Intervention MeSH terms: Abrocitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Phase 2; randomized; double-blind; placebo; plaque; psoriasis; safety; efficacy; JAK; janus kinase; moderate; severe

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).