TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment
- Registration Number
- NCT02711813
- Lead Sponsor
- Theramab LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAB08 Dose 2 TAB08 - Placebo Placebo Placebo to TAB08 TAB08 Dose 1 TAB08 -
- Primary Outcome Measures
Name Time Method Number and proportion of treatment responders per SLE Responder Index (SRI) 24 weeks Adverse Events 24 weeks
- Secondary Outcome Measures
Name Time Method Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36) 24 weeks Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 24 weeks
Trial Locations
- Locations (1)
Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences
🇷🇺Moscow, Russian Federation