A Two-Stage Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Various Doses of Levilimab When Administered Intravenously and Subcutaneously to Healthy Subjects and Subjects With Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Biocad
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Safety primary endpoint (Stage 1)
研究概览
简要总结
This is a two-stage study of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of various doses of levilimab when administered intravenously and subcutaneously to healthy subjects and subjects with active rheumatoid arthritis resistant to methotrexate monotherapy.
Aim of the Stage 1 is to study the tolerability, safety, immunogenicity, and main pharmacokinetic and pharmacodynamic parameters of levilimab after its single subcutaneous or intravenous administration at ascending doses to healthy subjects.
Aim of the Stage 2 is to confirm the efficacy and safety of levilimab 648 mg IV Q4W in combination with methotrexate and levilimab 324 mg SC Q2W in combination with methotrexate in subjects with active rheumatoid arthritis, resistant to methotrexate monotherapy.
详细描述
Stage 1: there are 3 dose levels and 5 cohorts. The subjects will be followed up for up to 71 days after the IP administration.
Stage 2: the main period of the study (Weeks 0-24) is blinded; study subjects will receive levilimab with placebo. At Week 24 the study will become open-label and all subjects will continue to receive levilimab. At week 28 patients who achieved the RA remission at week 24 will be switched to maintenance therapy of levilimab and will receive it through Week 52. Subjects who do not achieve remission at Week 24, will continue to receive levilimab from Week 28 to Week 52 inclusive corresponding to their treatment group.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LVL162 group
Levilimab 162 mg SC QW plus placebo starting from Week 0.
干预措施: Levilimab (Drug)
LVL324 group
Levilimab 324 mg SC Q2W plus placebo starting from Week 0.
干预措施: Levilimab (Drug)
LVL648 group
levilimab 648 mg IV Q4W plus placebo starting from Week 0.
干预措施: Levilimab (Drug)
结局指标
主要结局
Safety primary endpoint (Stage 1)
时间窗: Up to day 71
To determine the safety profile of levilimab following its single subcutaneous or intravenous administration at ascending doses in healthy subjects.
Low disease activity (Stage 2)
时间窗: Up to Week 24
Proportion of subjects with low activity of rheumatoid arthritis (DAS28-ESR \<3.2) at Week 24 of the study in each treatment group.
次要结局
- Changes in RA indexes (Stage 2, main period)(Week 24, 52)
- RA remission (Stage 2, main period)(Up to Week 52)
- PK endpoints (Stage 1)(Up to Week 52)
- ACR response (Stage 2, main period)(Week 24, 52)
- Low disease activity (Stage 2, main period)(Week 24, 52)
- Moderate/good response according to the EULAR criteria (Stage 2)(Week 24, 52)
- Change in the serum C-reactive protein concentration (Stage 2)(Week 24, 52)
- Change in ESR (Stage 2)(Week 24, 52)
- Change in the quality of life measured with SF-36 (Stage 2)(Week 24, 52)
- Change in the quality of life measured with the EQ-5D-3L (Stage 2)(Week 24, 52)
- Change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score (Stage 2)(Week 24, 52)
- Change in functional activity (Stage 2)(Week 24, 52)
- X-Ray assessment (Stage 2)(Week 24, 52)
- Key Secondary PK endpoint (Stage 2)(Week 24)