Safety of IFNa Kinoid in Systemic Lupus Erythematosus

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: IFN-K

• Registration Number: NCT01058343
• Lead Sponsor: Neovacs

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Study Start: 2010-03
• Primary Completion: 2011-04
• Study Completion: 2016-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IFN-K 1	IFN-K	IFN kinoid dose 1
IFN-K 3	IFN-K	IFN kinoid dose 3
IFN-K-2	IFN-K	IFN kinoid dose 2
IFN-K 4	IFN-K	IFN kinoid dose 4
Saline	IFN-K	saline at same dose as IFN K

Primary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events	study duration

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with anti IFNa antibodies	Month 4

Trial Locations

Locations (14)

University Hospital Split; 🇭🇷 Split, Croatia

Cliniques Universitaires St Luc; 🇧🇪 Brussels, Belgium

Geneva University Hospital; 🇨🇭 Geneva, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

KBC Zagreb; 🇭🇷 Zagreb, Croatia

MHAT "Sveti Ivan Rilski"; 🇧🇬 Sofia, Bulgaria

Hopital de la Pitie Salpetriere; 🇫🇷 Paris, France

Hopital Claude Huriez; 🇫🇷 Lille, France

Hopital Lapeyronie; 🇫🇷 Montpellier, France

Hopital du Kremlin Bicetre; 🇫🇷 Paris, France

Hopital Haut-Leveque; 🇫🇷 Pessac, France

Kerckhoff-Klinik Gmbh; 🇩🇪 Bad-Nauheim, Germany

Charite; 🇩🇪 Berlin, Germany

Inselspital; 🇨🇭 Bern, Switzerland