EUCTR2015-000372-95-HU进行中（未招募）1 期
A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY
Ablynx N.V.0 个研究点目标入组 300 人开始时间: 2015年6月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •1. Male or female adults = 18 years and < 65 years of age.
- •2. Have a diagnosis of SLE for at least 6 months prior to screening and fulfill the 1997 ACR or 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.
- •3. Have moderate to severe active SLE.
- •5. Have seropositive disease at screening.
- •6. Subject must be at least on one or more of the treatments for SLE as defined in the protocol.
- •Others as defined in the protocol.
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have an A score on the revised BILAG-2004 other than in the
- •mucocutaneous and/or musculoskeletal system at screening and at
- •baseline for the organ systems that can be clinically assessed.
- •2. Have a systemic inflammatory disease other than SLE.
- •3. Clinically significant infection treated or needing treatment.
- •4. Any active or recurrent viral infection that based on the
- •Investigator´s clinical assessment makes the subject unsuitable for the study.
- •5. Have a history of, or current, class III or IV congestive heart failure.
- •6. Have received prior therapy blocking the IL-6 pathway.
- •Others as defined in the protocol.
研究者
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