Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis
Condition: Psoriasis; Immunomodulation
MeSH terms: Psoriasis
Intervention: tofacitinib; tofacitinib; tofacitinib; tofacitinib; tofacitinib; tofacitinib
Intervention description: 5 mg BID For 13 days and once on Day 14; 10 mg BID for 13 days and once on Day 14*; 20 mg BID for 13 days and once on Day 14; 30 mg BID for 13 days and once on Day 14; 60 mg tablet once a day (QD) for 14 days; 50 mg tablets two times a day (BID) for 13 days and once on day 14
Intervention MeSH terms: Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Psoriasis; PASI; plaques; skin biopsy; immunomodulation

Summary:

      This study was conducted in subjects with psoriasis to evaluate drug activity in this patient
      population by analysis of changes in psoriatic lesion biopsy characteristics. This subject
      population was selected to evaluate potentially relevant biological activity of CP-690,550 as
      well as assessing safety and pharmacokinetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and/or female subjects between the ages of 18 and 65 years, inclusive, with
             active psoriasis lesion(s).

          -  Subjects should be healthy with the exception of psoriasis, where healthy is defined
             as no clinically relevant abnormalities identified by a detailed medical history, full
             physical examination. Blood pressure must be < 140/89. Body Mass Index (BMI) between
             18-36 kg/m2, inclusive; and a total body weight >50 kg (110 lbs)

          -  The following laboratory variables must be no more than 10% below the lower limit of
             the normal reference range: RBC, hemoglobin, hematocrit, WBC, absolute neutrophil
             count. The absolute lymphocyte count must be greater than or equal to the lower limit
             of the reference range. Values for AST, ALT, bilirubin and alkaline phosphatase must
             be no more than 10% above the upper limit of the normal reference range. Values for
             total cholesterol and LDL must be no more than 20% above the upper limit of the normal
             reference range except for subjects being treated for hyperlipidemia. Normal
             glomerular filtration rate (> 80 mL/min).

        Exclusion Criteria:

          -  Subjects with evidence or history of clinically significant hematological, renal,
             urological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
             psychiatric, neurologic disorder.

          -  Subjects with controlled essential hypertension and/or hyperlipidemia may be eligible
             for the study provided that any medications that are administered.

          -  Screening 12-lead ECG demonstrating at least one of the following: heart rate > 100
             bpm, QRS >120 msec, QTc > 430 msec (males), QTc > 450 msec (females) or PR > 220 msec.

          -  Abnormal chest radiographs including, but not limited to, evidence of past or present
             tuberculosis infection. History of tuberculosis without treatment and/or positive
             tuberculin reaction without known vaccination with BCG.

          -  Subjects with a history of tumors with the exception of adequately treated basal cell
             carcinoma of the skin.