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

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ClinicalTrials.gov Identifier: NCT02796053
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Theramab LLC

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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: TAB08 Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Assess Pharmacodynamics, Clinical Effects, Safety and Pharmacokinetics of TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Concomitant Therapy
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo to TAB08
Other: Placebo
The Placebo to TAB08 will be administered intravenously, by infusion.

Experimental: TAB08 Dose 1
Drug: TAB08 biologic
Drug: TAB08
The TAB08 will be administered intravenously, by infusion.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796053


Locations
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Russian Federation
Clinical Emergency Hospital of Yaroslavl
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Theramab LLC
Investigators
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Study Director: Daniil Nemenov, M.D. Theramab LLC

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Responsible Party: Theramab LLC
ClinicalTrials.gov Identifier: NCT02796053     History of Changes
Other Study ID Numbers: TAB08-PSO-01
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases