Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE).

Systemic lupus erythematosus (SLE) is a chronic, multisystem, disabling autoimmune condition, which predominantly affects women of childbearing years. Treatment options for SLE remain relatively limited. Regardless of the specific therapy chosen, the majority of patients continue to require long term immunomodulatory or cytotoxic therapy, resulting in long-term morbidity and mortality. Brentuximab vedotin is an antibody-drug conjugate (ADC) consisting of: 1) the chimeric immunoglobulin (Ig) G1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent monomethyl auristatin E (MMAE), and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10. Since CD30 and/or CD30-expressing immune cells may play significant key roles in the pathogenesis of SLE, brentuximab vedotin may be an efficacious therapy. This study intends to explore the potential for brentuximab vedotin as a therapy for SLE.

Inclusion Criteria:

• Adults ≥ 18 years
• Diagnosis of SLE for at least 6 months prior to screening
• Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening
• Must have failed a treatment for SLE after a trial of at least 3 months

Exclusion Criteria:

• The subject has any serious health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study
• Subject has had recent serious or ongoing infection, or risk for serious infection
• Subject has a history of new or recurrent malignancy within the past 5 years
• The subject is pregnant and/or breastfeeding
• The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study
• The subject has urgent, severe SLE disease activity, which, in the opinion of the Investigator, warrants immediate immunosuppressive therapy and would not be appropriate for the study