Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

Pfizer

Status and phase: Completed; Phase 1

Conditions: Immunomodulation; Psoriasis

Treatments: Drug: tofacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736696

A3921003

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 6 patient groups

5 mg BID

Experimental group

Description:

5 mg BID for 13 days and once on Day 14

Treatment:

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

10 mg BID

Experimental group

Description:

10 mg BID for13 days and once on Day 14\*

Treatment:

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

20 mg BID

Experimental group

Description:

20 mg BID for 13 days and once on Day 14

Treatment:

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

30 mg BID

Experimental group

Description:

30 mg BID for 13 days and once on Day 14

Treatment:

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

60 mg QD

Experimental group

Description:

60 mg QD for 14 days

Treatment:

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

50 mg BID

Experimental group

Description:

50 mg BID x 13 days and once on day 14

Treatment:

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib

Drug: tofacitinib