EUCTR2009-012059-47-BG进行中（未招募）1 期
A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus
eovacs SA0 个研究点目标入组 28 人开始时间: 2010年4月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 at the time of screening,
- •4. Male or female between 18 and 50 years of age included at the time of the first
- •planned administration of the study drug,
- •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 randomiza7. Vaccination against H1N1 influenza at least 7 days prior to randomization, if judged indicated by the Investigator. The nasal spray form of the vaccine is not acceptable as it is a live attenuated vaccine,
- •8. For subjects with reproductive potential (males and females), use of a reliable
- •means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, or other barrier method of contraception) throughout their
- •participation in the study, (i.e. until study Day 168 (Month 6 study visit),
- •unless additional extended follow up visits are needed in the presence of
- •persisting anti-IFNa antibodies. In this case, contraception must be continued
- •until anti-IFNa antibody levels are back to baseline and further follow visits
- •are no longer required,
- •9. According to the Investigator, able and willing to comply with the requirements of the study protocol (e.g., completion of the diary cards, return for follow-up visits),
- •10. Written informed consent obtained from the subject.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 highdose corticosteroids or the addition of an immunosuppressive
- •regimen during the course of the trial,
- •3. Received > 20 mg/day of prednisone, or 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 IFN alpha ,
- •8. Received B-cell depleting therapy (e.g. Rituximab) within 12 months prior to screening,
- •9. Received IV antibiotics during the 30 days prior to screening,
- •10. Significant electrocardiogram (ECG) abnormalities that are clinically relevant and
- •preclude study entry according to the Investigator’s opinion,
- •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 and precludes study entry according to the Investigator’s opinion, in particular subjects with already impaired functions of central organs at screening (e.g. AST > 2.5 x upper limit of the norm (ULN), ALT > 2,5 x ULN, creatinine > 1,5 x ULN, serum potassium above
- •or below the normal range, hemoglobin < 8g/dL, WBC < 1,800/mm3, neutrophils < 1,500/mm3, platelet count < 50,000/mm3, lupus with central manifestation) should be excluded from the study.
- •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 (e.g. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, rotavirus vaccine, varicella vaccine, zoster vaccine, Bacillus Calmette-Guérin vaccine),
- •21. Planned use of any investigational or non-registered product (drug or vaccine)
- •other than the study product within 30 days preceding the first dose of study product, or during the study period,
- •22. History of severe allergic or anaphylactic reactions to any component of the
- •kinoid and/or seafood,
- •23. Pregnancy or lactation,
- •24. History of chronic alcohol consumption and/or drug abuse within 6 months of
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