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

February 14, 2017 updated by: Theramab LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Yaroslavl, Russian Federation, 150003
        • Clinical Emergency Hospital of Yaroslavl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theramab LLC

Investigators

  • Study Director: Daniil Nemenov, M.D., Theramab LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAB08-PSO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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