Safety of IFNa Kinoid in Systemic Lupus Erythematosus

A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.

Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response.

This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease.

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