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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: TAB08
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo to TAB08 | Other: Placebo<br>* The Placebo to TAB08 will be administered intravenously, by infusion.<br>|
| Experimental: TAB08 Dose 1<br>Drug: TAB08 biologic | Drug: TAB08<br>* The TAB08 will be administered intravenously, by infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of T-lymphocytes subsets in absolute count (number of cells per mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline. |  | 12 weeks | 
| Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline. |  | 12 weeks | 
| Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline. |  | 12 weeks | 
| Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAB08 concentrations in peripheral blood |  | 12 weeks | 
| Adverse events frequency, seriousness and severity |  | 16 weeks | 
| Psoriasis Area Severity Index (PASI) |  | 16 weeks | 
| Investigator Global Assessment (IGA) |  | 16 weeks | 
| Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI) |  | 12 weeks |