A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- SLE Responder Index (SRI-4)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
详细描述
This two-stage study consists of a multicenter dose-escalation study（Phase Ib）and a multicenter randomized, double-blind, placebo-controlled study（Phase II）.
Primary objectives of the dose-finding stage: 1) Evaluate the efficacy, safety, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of intravenous IMC-002 and subcutaneous IMM0306S in adult patients with active systemic lupus erythematosus (SLE); 2) Determine the absolute bioavailability of subcutaneous IMM0306S relative to intravenous IMC-002 in adults with moderate-to-severe active SLE; 3) Select the recommended Phase II dose (RP2D).
Primary objectives of the proof-of-concept (PoC) stage: Compare the efficacy of 1.2 mg/kg or 1.6 mg/kg IMC-002 versus placebo in adults with moderate-to-severe active SLE, and assess the efficacy and population PK (popPK) profiles of IMM0306S in patients with active 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
- Double (Participant, Investigator)
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
- •Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
- •SLEDAI-2000 score ≥
- •For screening eligibility only, headache and fever items shall be excluded from SLEDAI-2K scoring. Skin lesions shall meet morphological and distributive characteristics of active cutaneous lupus, with a total active Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) score ≥
- •BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
- •Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
- •Other protocol defined inclusion criteria may apply.
排除标准
- •Active or unstable neuropsychiatric SLE or lupus nephritis
- •Autoimmune or rheumatic disease other than SLE
- •Significant, uncontrolled medical conditions not related to SLE
- •Active and/or severe viral, bacterial or fungal infection
- •History of malignancy within 5 years
- •Other protocol defined exclusion criteria may apply.
研究组 & 干预措施
IMC-002 + SOC
干预措施: IMC-002 + SOC (Drug)
Placebo + SOC
干预措施: Placebo + SOC (Drug)
IMM0306S + SOC
干预措施: IMM0306S + SOC (Drug)
结局指标
主要结局
SLE Responder Index (SRI-4)
时间窗: week 52
Proportion of patients achieving a response in SRI-4
SLE Responder Index (SRI-4)
时间窗: week 24
Proportion of patients achieving a response in SRI-4
AEs and SAEs
时间窗: week 52
The proportion of patients with AEs and SAEs
Pharmacokinetics profiles
时间窗: week 52
To characterize PK profiles and absolute bioavailability.
次要结局
- achieve low level of urine protein(week 52)
- SLE Responder Index (SRI-4)(week 24)
- achieve and sustain a low dose of corticosteroid(week 52)
- SLE Responder Index (SRI-4)(week 12 and 52)
- Lupus Low Disease Activity State (LLDAS)(week 24 and 52)
- Definition of Remission In SLE (DORIS)(week 24 and 52)
- SLEDAI-2000, PGA, BILAG-2004 and EQ-5D(week 52)
- Achieve and sustain a low dose of corticosteroid(week 52)
- Achieve low level of urine protein(week 52)
- Immunogenicity profiles(week 52)
- Serologic laboratory parameters(week 52)
- Pharmacodynamic (PD) assessments and biomarker evaluations(week 52)