Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety of IFNa Kinoid in Systemic Lupus Erythematosus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Neovacs
ClinicalTrials.gov Identifier:
NCT01058343
First received: January 27, 2010
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: IFN-K
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Neovacs:

Primary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients with anti IFNa antibodies [ Time Frame: Month 4 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFN-K 1
IFN kinoid dose 1
Biological: IFN-K
3 to 4 IM injections over 3 months
Experimental: IFN-K-2
IFN kinoid dose 2
Biological: IFN-K
3 to 4 IM injections over 3 months
Experimental: IFN-K 3
IFN kinoid dose 3
Biological: IFN-K
3 to 4 IM injections over 3 months
Experimental: IFN-K 4
IFN kinoid dose 4
Biological: IFN-K
3 to 4 IM injections over 3 months
Placebo Comparator: Saline
saline at same dose as IFN K
Biological: IFN-K
3 to 4 IM injections over 3 months

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058343

Locations
Belgium
Cliniques Universitaires St Luc
Brussels, Belgium
Bulgaria
MHAT "Sveti Ivan Rilski"
Sofia, Bulgaria
Croatia
University Hospital Split
Split, Croatia
KBC Zagreb
Zagreb, Croatia
France
Hopital Claude Huriez
Lille, France, 59037
Hopital Lapeyronie
Montpellier, France, 34295
Hopital de la Pitie Salpetriere
Paris, France
Hopital du Kremlin Bicetre
Paris, France
Hopital Haut-Leveque
Pessac, France
Germany
Kerckhoff-Klinik Gmbh
Bad-Nauheim, Germany
Charite
Berlin, Germany
Switzerland
Inselspital
Bern, Switzerland
Geneva University Hospital
Geneva, Switzerland
Geneva University Hospital
Geneva, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Sponsors and Collaborators
Neovacs
Investigators
Principal Investigator: Frederic Houssiau, MD, PhD Cliniques Universitaires St Luc, Brussels, Belgium
  More Information

No publications provided by Neovacs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neovacs
ClinicalTrials.gov Identifier: NCT01058343     History of Changes
Other Study ID Numbers: IFN-K-001
Study First Received: January 27, 2010
Last Updated: September 17, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Switzerland: Swissmedic
Bulgaria: Bulgarian Drug Agency
Croatia: Agency for Medicinal Product and Medical Devices

Keywords provided by Neovacs:
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 27, 2014