2025-523488-39-00招募中2 期
Randomised, placebo-controlled, double-blind, parallel-group Phase II study to evaluate the efficacy and safety of oral BI 3000202 in patients with moderate to severe systemic lupus erythematosus (SLE)
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.56 个研究点 分布在 7 个国家目标入组 106 人开始时间: 2026年4月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 56
- 主要终点
- Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32
研究概览
简要总结
The primary objectives are to demonstrate a non-flat dose response curve and to evaluate the treatment effect of different dose regimens of BI 3000202 vs. placebo based on the primary endpoint of achievement of SRI-4 response at Week 32 in patients with moderate to severe SLE.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to <75 years
- •Confirmed SLE diagnosis meeting the EULAR/ACR classification criteria at least 24 weeks prior to screening
- •At least one of the following positive at screening: antinuclear antibodies (ANA) ≥1:80 or anti-dsDNA antibody or anti-Smith antibody
- •Total SLEDAI-2K score ≥6 points and clinical SLEDAI-2K score ≥4 points
- •At least 1 BILAG A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator
- •On SLE background therapy with a maximum of 1 immunosuppressant and/or 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/or oral corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1)
- •Further inclusion criteria apply.
排除标准
- •Drug-induced SLE
- •Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments
- •Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy
- •Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or >2 × ULN and/or UPCR that is unstable or > 3mg/mg (339 mg/mmol)
- •Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening
- •Further exclusion criteria apply.
研究组 & 干预措施
BI 3000202, BI 3000202
Test
干预措施: BI 3000202 (Drug)
Placebo matching BI 3000202
Placebo
干预措施: Placebo matching BI 3000202 (Drug)
结局指标
主要结局
Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32
Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32
次要结局
- Achievement of SRI-4 response at Week 52
- Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent at Week 32
- Achievement of Lupus Low Disease Activity State (LLDAS) at Week 32
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (56)
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