Safety of IFNa Kinoid in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058343
• Other study ID #: IFN-K-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2010
• Est. completion date: June 2016

Study information

• Verified date: March 2019
• Source: Neovacs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2016
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• IFN-K
3 to 4 IM injections over 3 months

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Brussels
Bulgaria	MHAT "Sveti Ivan Rilski"	Sofia
Croatia	University Hospital Split	Split
Croatia	KBC Zagreb	Zagreb
France	Hopital Claude Huriez	Lille
France	Hopital Lapeyronie	Montpellier
France	Hopital de la Pitie Salpetriere	Paris
France	Hopital du Kremlin Bicetre	Paris
France	Hopital Haut-Leveque	Pessac
Germany	Kerckhoff-Klinik Gmbh	Bad-Nauheim
Germany	Charite	Berlin
Switzerland	Inselspital	Bern
Switzerland	Geneva University Hospital	Geneva
Switzerland	Geneva University Hospital	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Neovacs

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Croatia,  France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of adverse events		study duration
Secondary	Proportion of patients with anti IFNa antibodies		Month 4