A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: CEP-33457
Intervention description: CEP-33457 will be administered subcutaneously per dose specified in the arm description.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Lupus; SLE

Summary:

      The primary objective of this study is to evaluate the long term safety and tolerability of
      repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72
      weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have
      participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at
      least Visit 8 (Week 24 of that study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has an established diagnosis of SLE as defined by ACR Classification
             Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are
             met.

          -  The participant previously participated in and completed at least Visit 8 (Week 24)
             the Cephalon sponsored clinical study with CEP-33457 (study C33457/2047) and, in the
             investigator's opinion, would benefit from continued participation in a clinical
             study.

          -  Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing
             potential, using a medically accepted method of contraception, and must agree to
             continued use of this method for the duration of the study and for 30 days after
             discontinuation of study drug treatment.

        Exclusion Criteria:

          -  The participant has New York Heart Association (NYHA) Class III or IV congestive heart
             failure.

          -  The participant has an estimated glomerular filtration rate (eGFR) of less than 30
             milliliters (mL)/minute (min)/1.73 square meter (m^2) (via Modification of Diet in
             Renal Disease [MDRD] equation).

          -  The participant has an aspartate aminotransferase (AST) or alanine aminotransferase
             (ALT) value greater than 2 times the upper limit of normal (ULN) or a total bilirubin
             level greater than 1.5 times ULN.

          -  The participant has a planned immunization with a live or live attenuated vaccine
             within 3 months prior to administration of the first dose of study drug and for 3
             months after administration of the last dose of study drug.

          -  The participant has any clinically significant abnormalities on electrocardiogram
             (ECG) that are not related to SLE, as determined by the investigator. Participants
             with stable ECG changes without evidence of active cardiovascular disease may
             participate at the discretion of the investigator and medical monitor.

          -  The participant has an ongoing active systemic infection requiring treatment or a
             history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to
             administration of the first dose of study drug. Less severe infections in the 3 months
             prior to administration of the first dose of study drug are permitted at the
             discretion of the investigator and medical monitor.

          -  The participant has any concomitant medical condition unrelated to SLE that may
             interfere with his or her safety or with evaluation of the study drug, as determined
             by the investigator.

          -  The participant has a history of a positive test result for hepatitis B surface
             antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).

          -  The participant has a known positive history of antibodies to human immunodeficiency
             virus (HIV) or HIV disease.

          -  The participant has a history of alcohol or substance dependence or abuse (with the
             exception of nicotine), according to the Diagnostic and Statistical Manual of Mental
             Disorders of the American Psychiatric Association, Fourth Edition, Text Revision
             (DSM-IV-TR), within 3 months of the screening visit for study C33457/2047, or has
             current substance abuse.

          -  The participant has a history of severe allergic reactions to or hypersensitivity to
             any component of the study drug.

          -  The participant is a pregnant or lactating woman. (Any women becoming pregnant during
             the study will be withdrawn from the study.)

          -  The participant has undergone or is undergoing treatment with another investigational
             drug for the treatment of lupus within 6 months prior to the 1st dose of study drug or
             has received any other investigational drug for any other condition within 30 days
             prior to the 1st dose of study drug, except for treatment with CEP-33457 or placebo in
             study C33457/2047.

          -  The participant has a known history of antibodies to CEP-33457.

          -  The participant is unlikely to comply with the study protocol or is unsuitable for any
             other reason, as judged by the investigator or medical monitor.