NCT06975787招募中1 期
A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 19
- 主要终点
- Occurrence of Dose Limiting Toxicities (DLT)
研究概览
简要总结
This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN).
The main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up.
This is a main study, called an umbrella study, which includes several independent smaller sub-studies. Each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating LN.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key General Inclusion Criteria:
- •Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol
- •Participant must have refractory or relapsed disease, as described in the protocol
- •Key General
排除标准
- •History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization
- •Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
- •Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Experimental Arm 1: Vonsetamig
Experimental
干预措施: Vonsetamig (Drug)
Experimental Arm 2: Odronextamab
Experimental
干预措施: Odronextamab (Drug)
结局指标
主要结局
Occurrence of Dose Limiting Toxicities (DLT)
时间窗: Up to 56 days
Occurrence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Through week 76
Severity of TEAEs
时间窗: Through week 76
次要结局
- Proportion of participants receiving a corticosteroid dose of 0 mg per day(At 6 months)
- Proportion of participants receiving a corticosteroid dose of 0 mg per day(At 6 months)
- Cumulative total exposure to corticosteroids(At 76 weeks)
- Absolute values of urine Protein-Creatinine Ratio (uPCR)(Through week 76)
- Percent change from baseline of uPCR(Through week 76)
- Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine(Through week 76)
- Percent change from baseline of eGFR serum creatinine(Through week 76)
- Absolute values of blood B-cell counts and other immune cell populations(Through week 76)
- Change from baseline of blood B-cell counts and other immune cell populations(Through week 76)
- Absolute values of double-stranded DNA (dsDNA) antibodies(Through week 76)
- Percent change from baseline of dsDNA antibodies(Through week 76)
- Absolute values of anti-Smith antibodies(Through week 76)
- Percent change from baseline of anti-Smith antibodies(Through week 76)
- Absolute values of anti-C1q antibodies(Through week 76)
- Percent change from baseline of anti-C1q antibodies(Through week 76)
- Absolute values of other autoantibodies(Through week 76)
- Percent change from baseline of other autoantibodies(Through week 76)
- Absolute values of Complement Factor C3 (C3) circulating factors(Through week 76)
- Percent change from baseline of C3 circulating factors(Through week 76)
- Absolute values of Complement Factor C4 (C4) circulating factors(Through week 76)
- Percent change from baseline of C4 circulating factors(Through week 76)
- Absolute values of serum levels of Immunoglobulin A (IgA)(Through week 76)
- Percent change from baseline of serum levels of IgA(Through week 76)
- Absolute values of serum levels of Immunoglobulin G (IgG)(Through week 76)
- Percent change from baseline of serum levels of IgG(Through week 76)
- Concentrations of vonsetamig in serum over time(Through week 76)
- Concentrations of odronextamab in serum over time(Through week 76)
- Incidence of Anti-Drug Antibodies (ADAs) to vonsetamig(Through week 76)
- Incidence of ADAs to odronextamab(Through week 76)
- Titer of ADAs to vonsetamig(Through week 76)
- Titer of ADAs to odronextamab(Through week 76)
研究者
研究点 (19)
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