A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.


Eligibility Criteria:
Inclusion Criteria:

* For patients with reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) throughout their participation in the study
* Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria
* Disease duration of ≥ 1 year (after first diagnosis by a physician)
* Current immunity to measles, mumps, rubella, and varicella, as evidenced by positive IgG titers at the time of screening
* Current vaccination against influenza unless contraindicated in the investigator's judgment
* Normal Pap smear within the applicable time interval recommended by current American Cancer Society guidelines

Exclusion Criteria:

* Presence of active lupus nephritis
* Presence of active central nervous system (CNS) disease requiring treatment with high-dose corticosteroids or immunosuppressive agents
* Presence of active vasculitis requiring treatment
* History of arterial or venous thromboses within 12 months of screening
* Moderate to severe anemia, thrombocytopenia, or neutropenia
* Any manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial
* Pregnancy or lactation
* Lack of peripheral venous access
* History of alcohol or substance abuse within 6 months of screening
* History of severe allergic or anaphylactic reactions to antibodies or fusion proteins
* Evidence of significant uncontrolled concomitant diseases
* Significant laboratory or electrocardiogram (ECG) abnormalities
* Evidence of any clinically significant abnormality on a chest X-ray
* Severly impaired renal function
* Impaired hepatic function
* Poorly controlled diabetes
* Conditions other than SLE that could require treatment with corticosteroids
* History of malignancy except completely excised basal cell carcinoma
* Congenital immune deficiency
* Positive tests for antibodies to HIV, hepatitis B (HBS antigen, anti-HBC) or C
* Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
* Frequent recurrence of herpes lesions
* Episode of shingles within one year of screening
* Positive screening test for latent mycobacterium tuberculosis infection
* History of severe systemic bacterial, fungal, viral, or parasitic infections within the year prior to screening
* Any current or recent signs or symptoms of infection
* Received antibiotics orally (PO) during the 30 days prior to screening or IV antibiotics during the 60 days prior to screening
* Received a live vaccine within the 30 days prior to screening
* Has been hospitalized within the 30 days prior to screening
* Received \> 20 mg/day prednisone for \> 3 days during the 30 days prior to screening
* Received azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, pulse dose corticosteroids, intravenous immunoglobulin (IVIG), or transfusions within 6 months prior to screening
* Received cyclophosphamide within 2 years prior to screening
* Received a monoclonal antibody during the 12 months prior to screening
* Previously received an investigational treatment directed against interferon alpha
* Received B-cell depleting therapy (e.g., anti-CD20, anti-CD22)
* Received investigational treatment during the 30 days prior to screening