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

Theramab

Status and phase: Completed; Phase 2; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Other: Placebo; Drug: TAB08

Study type: Interventional

Funder types: Industry

Identifiers

NCT02796053

TAB08-PSO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo to TAB08

Treatment:

Other: Placebo

TAB08 Dose 1

Experimental group

Description:

Drug: TAB08 biologic

Treatment:

Drug: TAB08