EUCTR2009-012059-47-DE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1月21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
- •All subjects must satisfy the following inclusion criteria at study entry:
- •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 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 randomization,
- •7. Vaccination against H1N1 influenza at least 7 days prior to randomization.
- •The nasal spray form of the vaccine is not acceptable as it is a live attenuated
- •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,
- •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
- •The following exclusion criteria should be checked at the time of study entry. If any
- •apply, the subject must not be included in the study:
- •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 IFN!,
- •8. Received B-cell depleting therapy (e.g. Rituximab) within 12 months prior to
- •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,
- •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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