TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Treatment

Study to Assess Pharmacodynamics, Clinical Effects, Safety and Pharmacokinetics of TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Concomitant Therapy

Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08 during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled with current therapy.

1. To assess dynamics of the T-lymphocytes subpopulations in patients peripheral blood during 12 weeks of TAB08 treatment.
2. To assess dynamics of selected cytokines levels in patients peripheral blood during 12 weeks of TAB08 treatment.
3. To assess TAB08 concentrations in patients blood during 12 weeks of TAB08 treatment.
4. To assess frequency, seriousness and severity of adverse events during 12 weeks of TAB08 treatment.
5. To assess changes in PASI, IGA and DLQI during 12 weeks of TAB08 treatment and subsequent 4 weeks follow-up.

Inclusion Criteria:

• Confirmed diagnosis of Vulgar Psoriasis
• Area of Psoriasis skin damage ≥ 10%
• PASI Score ≥ 12
• Score on IGA scale ≥ 3

Exclusion Criteria:

• Other forms of psoriasis in addition to vulgar
• Prohibited treatment
• Pregnant or nursing women
• Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization