Safety of IFNa Kinoid in Systemic Lupus Erythematosus

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE Read More

Inclusion Criteria:

• 1. Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria (4 of 11 ACR criteria),
• 2. SLEDAI ≥4 and ≤10,
• 3. Positive Anti-nuclear Antibodies (ANA) and/or Positive anti-dsDNA antibodies
• 4. Male or female between 18 and 50 years of age
• 5. Current immunity to measles, mumps, rubella and varicella, as evidenced by positive IgG titers at the time of screening,
• 6. For subjects recruited during local influenza season, current vaccination against seasonal influenza at least 7 days prior to randomization,
• 7. Vaccination against H1N1 influenza at least 7 days prior to randomization.
• 8. For subjects with reproductive potential (males and females), use of a reliable means of contraception
• 9. Written informed consent obtained from the subject.

Exclusion Criteria:

• 1. Any serious manifestation of lupus at entry, that, in the opinion of the investigator is likely to require initiation of off-protocol medication changes during the course of the study and in particular no BILAG A score,
• 2. Any non-SLE 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,
• 3. Received > 20 mg/day of prednisone equivalent for > 7 days during the 30 days prior to screening,
• 4. Currently receiving or having received pulse dose corticosteroids or intravenous immunoglobulin (IVIg) within 3 months prior to screening,
• 5. Received cyclophosphamide within 3 months prior to screening,
• 6. Received a monoclonal antibody during the 6 months prior to screening,
• 7. Previously received an investigational treatment directed against IFNa,
• 8. Received B-cell depleting therapy (e.g. Rituximab) within 12 months
• 9. Received IV antibiotics during the 30 days prior to screening,
• 10. Significant electrocardiogram (ECG) abnormalities ,
• 11. Evidence of any clinically significant abnormality on a chest X-ray which, in the opinion of the investigator could represent active infection, latent tuberculosis or treatable manifestation of lupus,
• 12. Any laboratory abnormality that is clinically relevant
• 13. History of malignancy except completely excised basal cell carcinoma,
• 14. Congenital immune deficiency,
• 15. Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus (EBV) or cytomegalovirus (CMV),
• 16. Frequent recurrences of oral or genital herpes simplex lesions (≥ 6 / year),
• 17. Episode of shingles within one year of screening,
• 18. Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV) or HBV (HBsAg, anti-HBc ab) positive,
• 19. Any current signs or symptoms of infection at entry,
• 20. Administration of any live vaccine within the 3 months prior to study entry
• 21. Planned use of any investigational or non-registered product