TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment

Phase 2TerminatedNCT02711813

Theramab LLC60 enrolled

Overview

The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lupus Erythematosus, Systemic

Interventions

TAB08DRUG

biologic

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11) * Active SLE (SLE Disease Activity Index ≥ 6) * Skin or joint SLE manifestations Exclusion Criteria: * Lupus-nephritis and/or central nervous system affection (neuro-lupus) * Prohibited treatment * Pregnant or nursing women * Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization

Locations (1)

Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences

Moscow, Russia

Outcomes

Primary Outcomes

Number and proportion of treatment responders per SLE Responder Index (SRI)

Time frame: 24 weeks

Adverse Events

Time frame: 24 weeks

Secondary Outcomes

Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)

Time frame: 24 weeks

Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)

Time frame: 24 weeks

Data from ClinicalTrials.gov

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