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

• Status: Terminated
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theramab LLC

Criteria

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