EUCTR2010-024069-30-BG进行中（未招募）不适用
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •- Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, one of which must be:
- •a) Significantly positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at central lab; OR
- •b) Elevated anti-dsDNA or Sm antibody at screening as determined by central lab
- •- Disease history of SLE = 24 weeks at screening
- •- Weight > 40 kg
- •- Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives
- •- Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
- •- Females with an intact cervix must have no evidence of cervical malignancy documented on a Pap smear with 6 months of baseline
- •- Females must be willing to avoid pregnancy throughout the study including the 180 day follow-up safety period
- •- Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Active severe SLE-driven renal disease or unstable renal disease prior to screening
- •- Active severe or unstable neuropsychiatric SLE
- •- Clinically significant active infection including ongoing and chronic infections
- •- History of HIV
- •- Confirmed Positive tests for Hepatitis B or positive test for hepatitis C
- •- History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
- •- Herpes Zoster within 3 months of screening
- •- History of cancer other than basal cancer or cervical cancer treated with apparent success= 1 year prior to randomization
- •- Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer) prior to screening
- •- Live or attenuated vaccine within 4 weeks prior to screening
- •- Subjects with substance abuse
- •- Subjects with significant laboratory abnormalities in the hepatic, renal or hematologic systems
研究者
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