NCT05688696招募中2 期
A Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 41
- 主要终点
- SLE Responder Index (SRI) - 4 response rate
研究概览
简要总结
This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have had a detailed understanding of the nature, significance, potential benefits, potential risks, and procedures of the study, and voluntarily signed a written Informed Consent Form (ICF).
- •Males or females aged≥18 and ≤75 years.
- •Have a clinical diagnosis of SLE 6 months prior to signing the ICF, meeting at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
- •SLEDAI-2K≥8 at screening.
- •Are on a stable SLE SOC therapy consisting of any of the following medications for a period of at least 30 days prior to the first dose: glucocorticoid, and/or anti-malarials, and/or immunosuppressive agents.
- •Have a positive test for anti-dsDNA antibody (> normal range) and/or anti-nuclear antibody (ANA) and/or anti-Smith antibody at screening.
- •Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational agent. In this trial.
排除标准
- •Medical conditions:
- •Pregnant or lactating women, and men or women who have birth plans in the past 12 months.
- •Have neuropsychiatric systemic lupus erythematosus (NPSLE) within 6 months prior to the first dose, including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cranial neuropathy, cerebritis, cerebral vasculitis or lupus headache.
- •Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.
- •Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).
- •Have a history of any non-SLE disease that has required treatment with oral or intravenous or intramuscular or subcutaneous injection glucocorticoids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
- •Have a history of or current diagnosis of Central Nervous System (CNS) diseases.
- •Have clinically documented cardiovascular diseases that are obviously unstable or not effectively treated.
- •Have significant active lung diseases (e.g., interstitial lung disease, obstructive pulmonary disease).
- •Have severe hepatobiliary diseases.
- •Have a history of malignant neoplasm.
- •Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
- •Have known allergies to any component of the investigational agent as described in the Protocol.
- •Concomitant medication and surgery:
- •Have received rituximab, epratuzumab, or any other B cell-depleting therapy within 12 months prior to randomization.
- •Have received cyclophosphamide and chlorambucil within 6 months prior to randomization.
- •Have received belimumab, tumor necrosis factor (TNF) blockers, interleukin receptor blockers or other biological agents within 3 months prior to randomization (or 5 half-lives, whichever is longer).
- •Have a positive test for human immunodeficiency virus (HIV) antibody.
- •Have a positive test for Hepatitis B Surface Antigen (HBsAg) or hepatitis C antibody, or have a positive test for hepatitis B virus (HBV) DNA by Polymerase Chain Reaction (PCR) if positive for Hepatitis B Core Antibody (HBcAb).
- •Have abnormal tissue or organ function, meeting any of the following at screening:
- •Absolute neutrophil count (ANC) < 1.5 × 10^9/L; hemoglobin < 90 g/L; lymphocyte count < 0.8 × 10^9 /L.
- •Calculated estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation < 45 mL/min/1.73 m
- •Have other conditions that are not appropriate for participation in the trial as considered by the investigator.
研究组 & 干预措施
Orelabrutinib Lower Dose
Experimental
干预措施: Orelabrutinib (Low Dose) (Drug)
Orelabrutinib Higher Dose
Experimental
干预措施: Orelabrutinib (High Dose) (Drug)
Placebo
Placebo Comparator
干预措施: Orelabrutinib Placebo (Drug)
结局指标
主要结局
SLE Responder Index (SRI) - 4 response rate
时间窗: Week 48
SRI-4 response is defined as: 1)≥4 point reduction from baseline in SLE disease activity index-2000 (SLEDAI-2K) score; 2) no worsening (increase of \<0.3 points from baseline) in Physician's Global Assessment (PGA); 3) no new A organ domain score or no more than 1 new B organ domain scores compared with baseline in British Isles Lupus Assessment Group (BILAG)-2004.
次要结局
- British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rate(Week 48)
- SLE Responder Index (SRI) - 6 response rate(Week 48)
- Time to 1st flare(Week 48)
- The proportion of subjects whose average prednisone dose has been reduced by≥25% from baseline to ≤7.5 mg/day(Week 48)
- Changes from baseline in the levels of complement C3, complement C4, and anti-dsDNA antibody(Week 48)
- Treatment Emergent Adverse Events, Treatment Related Adverse Events, Treatment Emergent Serious Adverse Events, Treatment Related Serious Adverse Events.(Up to Week 52)
- Mean change from baseline in the 36-Item Short Form Health Survey (SF-36) scores (The SF-36 consists of eight domains. Each domain score ranges from 0-100. The higher the score, the better the health. )(Week 48)
研究者
研究点 (41)
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