jRCT2080225306已完成2 期
A 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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen K.K.
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Allocation: Randomized Masking: None (Open Label) Intervention Model: Parallel Assignment This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and immunomodulators.
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Inclusion Criteria Screening Visit:
- •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.
- •Hybrid SLEDAI score >= 6 points with a "Clinical" hSLEDAI score >= 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
- •Additional protocol-specific rules are applied at screening and throughout the study, as follows:
- •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 >=
- •Oral ulcers: Ulcers location and appearance must be documented by the investigator.
- •Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded.
- •Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI >= 4 and did not receive induction treatment for nephritis within the last year.
- •Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI.
- •Unless there is a documented intolerance, subjects must be taking:
- •Only 1 of the following SLE treatments: anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone.
- •2 of the above-mentioned SLE treatments in which 1 must be anti-malarial (hydroxychloroquine, chloroquine, or quinacrine).
- •Treatment should be taken for >= 12 weeks prior to screening and must be a stable dose for >= 8 weeks prior to screening.
- •For subjects taking OCS, dose must be <= 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit for >= 2 weeks prior to screening visit.
排除标准
- •Exclusion Criteria Screening Visit
- •Subjects are excluded from the study if any of the following criteria apply:
- •Disease Related:
- •Urine protein creatinine ratio >= 3000 mg/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.
结局指标
主要结局
-
1. Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52 [Time Frame: Week 52] SRI-4 response at Week 52 is defined as a >= 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to3), and no use of more than protocol allowed therapies.
次要结局
未报告次要终点
研究者
研究点 (1)
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