A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Anti-BDCA2 Antibody SSGJ-626 in Subjects With Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events
研究概览
简要总结
This study will evaluate the effect and safety of 626 in patients with SLE
详细描述
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities.
The purpose of this study is to demonstrate the clinical efficacy and safety of 626 added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with SLE.
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
- •Able to understand protocol requirements and sign a written ICF.
- •Male or female subjects aged 18-70 years when signing the ICF.
- •Body weight between 40 and 90 kg.
- •Diagnosed with SLE at least 6 months before the Screening Visit by a qualified physician，confirmed according to the 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE.
- •At screening, meet at least one of the following criteria:
- •Anti-nuclear antibody (ANA) titer ≥ 1:80;
- •Positive anti-dsDNA antibody..
- •Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 with clinical SLEDAI score ≥4 points at Screening and Baseline Visit .
- •Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
排除标准
- •Study participant has a mixed connective tissue disease, and/or overlap syndrome of systemic lupus erythematosus (SLE) with systemic sclerosis.
- •Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition
- •Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •History of cancer.
- •Active severe lupus nephritis present within 2 months prior to baseline. Or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or protein:creatinine ratio >2.0 g/g.
研究组 & 干预措施
Group M1
dose level 1 of 626
干预措施: 626 (Drug)
Group M1
dose level 1 of 626
干预措施: Placebo (Drug)
Group M2
dose level 2 of 626
干预措施: 626 (Drug)
Group M2
dose level 2 of 626
干预措施: Placebo (Drug)
Group M3
dose level 3 of 626
干预措施: 626 (Drug)
Group M3
dose level 3 of 626
干预措施: Placebo (Drug)
Group M4
dose level 4 of 626
干预措施: 626 (Drug)
Group M4
dose level 4 of 626
干预措施: Placebo (Drug)
626 Dose A
626 Dose A subcutaneous (SC) injection.
干预措施: 626 (Drug)
626 Dose B
626 Dose B subcutaneous (SC) injection
干预措施: 626 (Drug)
Placebo
Placebo subcutaneous (SC) injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Adverse Events
时间窗: During the 32- or 36-week study period
Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
次要结局
- SLE Responder Index (SRI-4)(During the 20- or 24-week treatment period)
- BILAG-based Combined Lupus Assessment (BICLA) Response(During the 20- or 24-week treatment period)