JPRN-jRCT2071210076招募中3 期
The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy - Tulip SC
Hibi Kazushige0 个研究点目标入组 36 人开始时间: 2021年10月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
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
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for 24 weeks prior or more to signing the ICF
- •2. To be eligible a patient must have SLEDAI-2K 6 points or more and Clinical SLEDAI-2K score 4 points or more at screening
- •3. BILAG2004 with at least 1 of the following:
- •- BILAG2004 level A disease in 1 organ system or more
- •- BILAG2004 level B disease in 2 organ systems or more
- •4. Physician's Global Assessment (PGA) score 1.0 or more on a 0 to 3 VAS at Screening
- •5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
- •6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.
排除标准
- •7. Active severe or unstable neuropsychiatric SLE
- •8. Active severe SLE-driven renal disease
- •9. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
- •10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
- •11. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
- •12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
- •13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
- •14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
- •15. History of cancer, apart from:
- •a. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy 3 months prior or more to Week 0 (Day 1)
- •b. Cervical cancer in situ treated with apparent success with curative therapy 1 year prior or more to Week 0 (Day 1).
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