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

Phase 1

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Other: Placebo; Drug: TAB08

• Registration Number: NCT02796053
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo to TAB08
TAB08 Dose 1	TAB08	Drug: TAB08 biologic

Primary Outcome Measures

Name	Time	Method
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
Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.	12 weeks
Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.	12 weeks
Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Emergency Hospital of Yaroslavl; 🇷🇺 Yaroslavl, Russian Federation