A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus

A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE

The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).

This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.

Inclusion Criteria:

• Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE)
• Score greater than or equal to (>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening
• Ability to complete the study period, including follow-up period through Day 169
• Willingness to forego other forms of experimental treatment during the study.

Exclusion Criteria:

• History of cancer except basal cell carcinoma treated with apparent success with curative therapy >=1 year before randomization into the study
• Evidence of active or latent tuberculosis (TB)
• History of primary immunodeficiency
• Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening
• History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection
• Any history or evidence of opportunistic infection within 6 months of Screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
• Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening
• Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.