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NCT Number: NCT02796053

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

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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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Emergency Hospital of Yaroslavl

Yaroslavl, 150003, Russia

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAB08

Drug

The TAB08 will be administered intravenously, by infusion.

Placebo

Other

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

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.

    Time frame: 12 weeks

  3. Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.

    Time frame: 12 weeks

  4. Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.

    Time frame: 12 weeks

Secondary outcomes

  1. TAB08 concentrations in peripheral blood

    Time frame: 12 weeks

  2. Adverse events frequency, seriousness and severity

    Time frame: 16 weeks

  3. Psoriasis Area Severity Index (PASI)

    Time frame: 16 weeks

  4. Investigator Global Assessment (IGA)

    Time frame: 16 weeks

  5. Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Theramab LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2016
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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