Phase 2a, Randomized, Double-blind, Placebo-controlled Trial of PRV-3279 EVAluation In Lupus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 36
- 主要终点
- To evaluate the ability of PRV-3279 to prevent flare, defined by LFA international consensus definition of flare, worsening on CGIC, and increase in hSLEDAI/BILAG scores
研究概览
简要总结
The PREVAIL-2 study is designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) patients with active disease after amelioration induced by corticosteroid treatment.
详细描述
This is a randomized, double-blind, placebo-controlled study in adult patients with active SLE. Approximately 100 eligible patients will be randomized at a 1:1 ratio to receive treatment with either PRV-3279 or placebo.
Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of SLE for at least 6 months.
The study drug will be administered every 4 weeks for 20 weeks in a double-blind fashion, followed by an 8-week safety follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of SLE for at least 6 months prior to the Screening visit
- •Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for SLE at Screening
- •Have moderate to severe disease activity despite stable standard-of-care medication defined as:
- •At screening: hSLEDAI score ≥6 (≥4 points of which must come from non-serological finding), OR at least one BILAG A or one B score; At randomization: ≥4-point drop in hSLEDAI, OR one BILAG letter grade improvement in at least one A or B score present at Screening, and investigator or central adjudication committee (CAC) rating of definite improvement or major or complete improvement
- •Able and willing to stop all lupus treatments, except antimalarials, corticosteroids (prednisone equivalent ≤ 10 mg), and NSAIDs
排除标准
- •Active lupus nephritis or active central nervous system manifestations of SLE
- •Other inflammatory or autoimmune diseases that, in the opinion of the Investigator or CAC, may confound efficacy evaluations
- •Common variable immunodeficiency syndrome or any other clinically significant immunodeficiency
- •Known COVID-19 infection in the 4 weeks before Screening or positive SARS-CoV-2 RNA test
- •Received a live attenuated vaccine within 2 months of Screening, received a non-live or mRNA vaccine within 2 weeks of Screening, or expecting to receive any vaccine during the study period
- •Any recent infection requiring antibiotics within two weeks of Screening or any recent infection requiring IV antibiotics or hospitalization within 1 month of Screening
- •Any condition for which, in the opinion of the Investigator or CAC, participation in the study would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments
- •Participated in any interventional clinical trial within 42 days prior to Screening or within five half-lives of the investigational product, whichever is longer
- •Received rituximab or equivalent treatment that depletes B cells within 6 months of Screening unless return of B cells to pre-treatment value or normal range can be demonstrated.
- •Received tumor necrosis factor inhibitors, interleukin antagonists, or other biologics, including belimumab, within 42 days or five half-lives of the agent, whichever is longer.
- •Received IV immunoglobulin (IVIG) or IV cyclophosphamide within 2 months, prednisone ≥ 100 mg/day for more than 30 days within 2 months, or plasmapheresis within two months of the Screening visit.
研究组 & 干预措施
PRV-3279
Sterile solution for intravenous administration, every 4 weeks
干预措施: PRV-3279 (Biological)
Placebo
Sterile solution for intravenous administration, every 4 weeks
干预措施: Placebo (Other)
结局指标
主要结局
To evaluate the ability of PRV-3279 to prevent flare, defined by LFA international consensus definition of flare, worsening on CGIC, and increase in hSLEDAI/BILAG scores
时间窗: 24 weeks
A flare is defined according to LFA international consensus definition of flare, worsening on Clinician's Global Impression of Change (CGIC), increases in hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)/British Isles Lupus Assessment Group (BILAG) Index scores
次要结局
- To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids(24 weeks)
- To evaluate the safety of PRV-3279(32 weeks)