CTRI/2012/06/002731已完成2 期
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- MedImmune
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 less or equal 24 weeks at screening
- •Weight less than 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
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 less or equal 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
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