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Safety of IFNa Kinoid in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT01058343
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Neovacs

Tracking Information
First Submitted Date  ICMJE January 27, 2010
First Posted Date  ICMJE January 28, 2010
Last Update Posted Date March 21, 2019
Study Start Date  ICMJE March 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2010)
Frequency and severity of adverse events [ Time Frame: study duration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2010)
Proportion of patients with anti IFNa antibodies [ Time Frame: Month 4 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of IFNa Kinoid in Systemic Lupus Erythematosus
Official Title  ICMJE A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Biological: IFN-K
3 to 4 IM injections over 3 months
Study Arms  ICMJE
  • Experimental: IFN-K 1
    IFN kinoid dose 1
    Intervention: Biological: IFN-K
  • Experimental: IFN-K-2
    IFN kinoid dose 2
    Intervention: Biological: IFN-K
  • Experimental: IFN-K 3
    IFN kinoid dose 3
    Intervention: Biological: IFN-K
  • Experimental: IFN-K 4
    IFN kinoid dose 4
    Intervention: Biological: IFN-K
  • Placebo Comparator: Saline
    saline at same dose as IFN K
    Intervention: Biological: IFN-K
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2010)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Croatia,   France,   Germany,   Switzerland
Removed Location Countries Romania,   Spain
 
Administrative Information
NCT Number  ICMJE NCT01058343
Other Study ID Numbers  ICMJE IFN-K-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neovacs
Study Sponsor  ICMJE Neovacs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Jorgensen, MD, PhD Unité Clinique d'Immuno-Rhumatologie Thérapeutique, Hôpital Lapeyronie, Montpellier, France
PRS Account Neovacs
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP