A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

Exclusion Criteria

• •Received intra-articular, intralesional, subcutaneous, intradermal, intramuscular or IV pulse corticosteroids 6 weeks prior to the Baseline Visit.
• •Received any other biologic or non-biologic immunosuppressive agent within 2 months of 5 pharmacokinetic half-lives (whichever is longer) prior to the Baseline Visit.
• •Have severe lupus nephritis defined as: estimated glomerular filtration rate of \< 45 mL/1.73 m2 or proteinuria \> 2000 mg/day based on protein to creatinine ratio, or active lupus nephritis that may require 'induction' therapy
• •Have active, severe or unstable neuropsychiatric lupus disease within 6 months of the Screening Visit.
• •Have serologic tests consistent with infection with either hepatitis B or hepatitis C, and/or confirmed history of hepatitis B or hepatitis C infection.
• •Have history of congenital and/or acquired immunodeficiencies (eg, common variable immunodeficiency, human immunodeficiency virus, etc).
• •Have active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, or any major episode of infection requiring hospitalization or treatment with intravenous or oral antibiotics within 4 weeks of the Screening Visit and at any time during the Screening Phase, up through the first dose of IP.
• •Have active tuberculosis or a history of latent or active tuberculosis
• •Have malignancy or history of malignancy, except for:
• •* treated (eg, cured) basal cell or squamous cell in situ skin carcinomas
• •* treated (eg, cured) cervical intraepithelial neoplasia Grade 1 and Grade 2
• •* treated (eg, cured) carcinoma in situ of the cervix with no evidence of recurrence within 5 years of the Screening Visit.
• •Have a diagnosis or history consistent with Antiphospholipid Syndrome or "triple antiphospholipid positivity" (ie, positive lupus anticoagulant, anticardiolipin, and anti-B2 glycoprotein).
• •Have history of arterial or venous thrombosis
• •Have history or current diagnosis of peripheral neuropathy (sensory or motor) ≥ Grade 2.
• •Have presence of active uveitis or any other ophthalmological finding that in the opinion of the Investigator is clinically significant.
• •Have other non-SLE driven inflammatory joint or skin disease or overlap syndromes as the primary disease.
• •Have clinically significant or unstable or uncontrolled acute or chronic disease not due to SLE
• •Does not meet required laboratory criteria.
• •Does not meet pre-specified periods for prohibited medications.
• •Pregnant or a breast-feeding female.