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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796053
• Other study ID #: TAB08-PSO-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 24, 2016
• Last updated: February 14, 2017
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Theramab LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• TAB08
The TAB08 will be administered intravenously, by infusion.

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

Locations

Country	Name	City	State
Russian Federation	Clinical Emergency Hospital of Yaroslavl	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Theramab LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.		12 weeks
Primary	Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.		12 weeks
Primary	Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.		12 weeks
Secondary	TAB08 concentrations in peripheral blood		12 weeks
Secondary	Adverse events frequency, seriousness and severity		16 weeks
Secondary	Psoriasis Area Severity Index (PASI)		16 weeks
Secondary	Investigator Global Assessment (IGA)		16 weeks
Secondary	Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI)		12 weeks