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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo to TAB08 |
|
| TAB08 Dose 1 | Experimental | Drug: TAB08 biologic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAB08 | Drug | The TAB08 will be administered intravenously, by infusion. |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TAB08 concentrations in peripheral blood | 12 weeks | |
| Adverse events frequency, seriousness and severity | 16 weeks | |
| Psoriasis Area Severity Index (PASI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniil Nemenov, M.D. | Theramab LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Emergency Hospital of Yaroslavl | Yaroslavl | 150003 | Russia |
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| ID | Term |
|---|---|
| C509303 | TGN-1412 |
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| Placebo |
| Other |
The Placebo to TAB08 will be administered intravenously, by infusion. |
|
| 16 weeks |
| Investigator Global Assessment (IGA) | 16 weeks |
| Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI) | 12 weeks |