NCT04924296Unknown2 期
A Multicentre, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of fSHR-1314 in Adult Patients With Lupus Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- percentage change of 24 hours UPCR from baseline to Week 12.
研究概览
简要总结
To demonstrate the efficacy of SHR-1314 at Week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h UPCR, compared to placebo. The study will also assess the safety and tolerability of SHR-1314 in the patient population over the study 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese adult pts (18-65yr), Male or Female
- •BMI≥18 kg/m2 and ≤ 35kg/m2
- •Confirmed diagnosis of LN, renal biopsy report data is within 3-months prior to the date of ICF is first signed
- •3.1 Biopsy-proven proliferative lupus nephritis Class III or Class IV, either with or without the presence of Class V, using the 2003 ISN/RPS criteria.
- •3.2 24h UPCR ≥ 1 at screening.
- •3.3 24h UPR ≥ 1.0 g/d，≤ 3.5 g/d.
- •3.4 eGFR > 45ml/min/1.73m
- •SLEDAI-2K≥8.
排除标准
- •Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE)
- •Subjects who have previously treated by both CYC and MMF (or other forms of mycophenolate)
- •With a hHistory of using 60 mg/d prednisolone (or equivalent dose) for more than 3 months prior to Baseline
- •History of inflammatory bowel disease or have other ongoing active autoimmune diseases
- •Required management of acute or chronic infections within the past 8 weeks.
- •At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •History of congestive heart failure (New York Heart Association [NYHA] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study.
- •History of depression and/or suicidal ideation or any suicidal behavior based on an assessment using the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline . The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide
- •Receipt of any IL-17/IL-17R targeted therapy within the past year.
- •Those who have participated in any clinical study for any drug or medical device within 3 months before screening.
- •Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •All subjects will be tested for tuberculosis status using IGRA and X-ray test. Subjects with active or latent tuberculosis will be excluded
- •History of severe allergic reaction to contrast agents or biological medicines.Current drug or alcohol abuse or dependence.
- •History of severe allergic reaction to contrast agents or biological medicines.Current drug or alcohol abuse or dependence.
- •Pregnant or nursing..
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR-1314 (Drug)
Treatment group B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
percentage change of 24 hours UPCR from baseline to Week 12.
时间窗: at 12 weeks
次要结局
- Percentage change of 24 hours UPCR from baseline to Week 24(from baseline to Week 24)
- Percentage change of 24 hours UPCR from Week 12 to Week24(from Week 12 to Week24)
- Percentage of pts achieving renal Partial Response at Week 12 and Week 24(at Week 12 and Week 24)
- Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24(at Week 12 and Week 24)
- Percentage of participants achieving renal Complete Response at Week 12 and Week 24(at Week 12 and Week 24)
- Change in SLEDAI-2K from baseline to Week 12 and Week 24(from baseline to Week 12 and Week 24)
- Change in PGA from baseline to Week 12 and Week 24(from baseline to Week 12 and Week 24)
研究者
相似试验
Enrolling By Invitation
3 期
The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.Small-cell Lung CancerNCT04691063Jiangsu HengRui Medicine Co., Ltd.486
已完成
1 期
A Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications DevicesModerate-to-Severe Plaque PsoriasisNCT06182384Suzhou Suncadia Biopharmaceuticals Co., Ltd.46
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus NephritisLupus NephritisNCT02256150Asahi Kasei Pharma Corporation250
已完成
3 期
SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical ResearchPrimary HypercholesterolemiaNCT04844125Jiangsu HengRui Medicine Co., Ltd.144
Unknown
2 期
A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial HypercholesterolemiaFamilial HypercholesterolemiaNCT04455581Jiangsu HengRui Medicine Co., Ltd.8