EUCTR2019-000328-16-IT进行中（未招募）1 期
Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
AMGEN INC.0 个研究点目标入组 320 人开始时间: 2021年6月15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
- 320
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
- •- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
- •- Age > = 18 years to < = 75 years at screening visit.
- •- Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody > = 1:80 by immunofluorescence on Hep-2 cells being present at screening. Anti-dsDNA results based on the Farr assay will be used to SLE classification criteria, while test results from the Phadia method will be used for the purposes of hSLEDAI scoring during screening and throughout the study
- •- Hybrid SLEDAI-2K score > = 6 points with Clinical hSLEDAI-2K score > = 4 points.
- •The Clinical hSLEDAI-2K is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results including urine or immunologic parameters.
- •Additional protocol specific rules:
- •o Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring
- •- Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia > = 2
- •- Oral ulcers: Ulcers location and appearance must be documented by the investigator
- •*Please, refer to protocol for the full list
- •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 295
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- Urine protein creatinine ratio >= 3000mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit
- •- Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
- •- Diagnosis of any inflammatory joint or skin disease other than SLE (confirmed accurate by the PI) which would interfere with SLE disease assessment based on investigator judgement.
- •- Any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 6 weeks prior to screening.
- •*Please, refer to protocol for the full list
研究者
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