A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.

Inclusion Criteria

Part 1

• The subject has an established diagnosis of systemic lupus erythematosus (SLE) as defined by the 1997 Update of the 1982 ACR Revised Criteria for Classification of SLE at screening. The diagnosis is fulfilled provided that at least 4 criteria are met.
• Disease history of SLE ≥ 6 months at baseline
• Females of childbearing potential (FCBP) must:
• Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.
• Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
• Male subjects must:
• Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy.
• If the subject is using oral corticosteroids, the daily dose must be less than or equal to 10 mg of prednisone or equivalent during the study; the dose must be stable over the 4 weeks preceding screening and throughout the study.
• All subjects taking hydroxychloroquine, chloroquine and/or quinacrine during the study must have documentation of a normal ophthalmologic examination performed within 1 year of the Baseline Visit.
• For subjects not taking corticosteroids, or antimalarials, the last dose (in case of previous use) must be at least 4 weeks prior to screening.

ATEP

• Male or female 18 years of age or older
• Understand and voluntarily sign an ICD prior to the initiation of any study related assessments/procedures
• Able to adhere to the study visit schedule and other protocol requirements. Pregnancy
• Females of childbearing potential (FCBP) must:
• Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.
• Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
• Male subjects must:
• Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
• Male subjects must agree not to donate semen or sperm during therapy and for at least 90 days following the discontinuation of IP.
• All subjects must:
• Understand that the IP could have potential teratogenic risk
• Agree to abstain from donating blood while taking IP and for 28 days following discontinuation of the IP
• Agree not to share IP with another person
• Other than the subject, FCBP and males able to father a child should not handle the IP or touch the capsules unless gloves are worn
• Be counseled about pregnancy precautions and risks of fetal exposure