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

Primary Purpose

Psoriasis Vulgaris

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

TAB08

Placebo

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Clinical Emergency Hospital of Yaroslavl

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

TAB08 Dose 1

Arm Description

Placebo to TAB08

Drug: TAB08 biologic

Outcomes

Primary Outcome Measures

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.

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

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

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

Secondary Outcome Measures

TAB08 concentrations in peripheral blood

Adverse events frequency, seriousness and severity

Psoriasis Area Severity Index (PASI)

Investigator Global Assessment (IGA)

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

Full Information

NCT ID

NCT02796053

First Posted

May 24, 2016

Last Updated

February 14, 2017

Sponsor

Theramab LLC

1. Study Identification

Unique Protocol Identification Number

NCT02796053

Brief Title

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

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theramab LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo to TAB08

Arm Title

TAB08 Dose 1

Arm Type

Experimental

Arm Description

Drug: TAB08 biologic

Intervention Type

Drug

Intervention Name(s)

TAB08

Intervention Description

The TAB08 will be administered intravenously, by infusion.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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 Measure Information:

Title

TAB08 concentrations in peripheral blood

Time Frame

12 weeks

Title

Adverse events frequency, seriousness and severity

Time Frame

16 weeks

Title

Psoriasis Area Severity Index (PASI)

Time Frame

16 weeks

Title

Investigator Global Assessment (IGA)

Time Frame

16 weeks

Title

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniil Nemenov, M.D.

Organizational Affiliation

Theramab LLC

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Emergency Hospital of Yaroslavl

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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