NCT02796053

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Theramab LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	TAB08	The TAB08 will be administered intravenously, by infusion.
OTHER	Placebo	The Placebo to TAB08 will be administered intravenously, by infusion.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-06-10
• Last updated: 2017-02-15

Locations

1 site across 1 country: Russia