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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02796053

Enrollment

Registered

2016-06-10

Start date

2016-04-30

Completion date

2016-12-31

Last updated

2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

Brief summary

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

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.

Interventions

DRUGTAB08

The TAB08 will be administered intravenously, by infusion.

OTHERPlacebo

The Placebo to TAB08 will be administered intravenously, by infusion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026