NCT07621939尚未招募2 期
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of IMM0306 in Participants With IgG4-Related Disease (IgG4-RD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 125
- 主要终点
- Time to disease relapse
研究概览
简要总结
The goal of this clinical trial is to learn if IMM0306 works to reduce the risk of disease relapse in participants with IgG4-related disease (IgG4-RD). It will also learn about the safety and tolerability of IMM0306. The main questions it aims to answer are:
- Does IMM0306 reduce the risk of disease relapse in participants with IgG4-RD?
- What medical problems do participants have when receiving IMM0306?
- How does IMM0306 behave in the body, and does the body develop anti-drug antibodies against IMM0306? In the Phase II part, all participants will receive IMM0306. In the Phase III part, researchers will compare IMM0306 with placebo to evaluate whether IMM0306 reduces the risk of disease relapse in participants with IgG4-RD.
Participants will:
- Receive IMM0306 or placebo by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
- Start a planned glucocorticoid taper from Day 1 and gradually reduce oral prednisone or equivalent until complete discontinuation after 8 weeks
- Visit the study site for efficacy and safety assessments, including disease relapse assessment, IgG4-RD responder index assessment, laboratory tests, imaging examinations, electrocardiograms, pharmacokinetic sampling, immunogenicity sampling, biomarker sampling, and adverse event assessment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of IgG4-RD;
- •Meeting 2019 ACR/EULAR classification criteria with an inclusion score ≥20;
- •At least two organs/sites involved during the disease course;
- •Prior or recent IgG4-RD flare requiring initiation or continuation of GC treatment at informed consent.
排除标准
- •Fibrotic manifestation as the only clinical manifestation of the current relapse;
- •Significant hematologic or hepatic abnormalities;
- •Recent B-cell-depleting therapy, alkylating agents, DMARDs or immunosuppressants;
- •Other chronic active immune diseases requiring long-term use of immunosuppressants;
- •Active malignancy or active malignancy within 10 years;
- •Significant cardiac disease;
- •Active infection or active TB;
- •Severe pulmonary disease;
- •Recent opportunistic infection;
- •Alcohol/drug abuse;
- •Pregnancy, lactation or failure to meet contraception requirements.
研究组 & 干预措施
Phase III control arm
Placebo Comparator
干预措施: Placebo (Drug)
Phase II single arm
Experimental
干预措施: IMM0306 (Drug)
Phase III treatment arm
Experimental
干预措施: IMM0306 (Drug)
结局指标
主要结局
Time to disease relapse
时间窗: From Day 1 to the end of Week 26/52
次要结局
- Incidence of AEs(From Day 1 to the end of Week 52)
- Incidence of ADA(From Day 1 to the end of Week 38)
- Cmax(From Day 1 to the end of Week 29)
- Cmin(From Day 1 to the end of Week 29)
- Annualized relapse rate(From Day 1 to the end of Week 26/52)
- Cumulative glucocorticoid dose(From Day 1 to the end of Week 52)
- Proportion of relapse-free and glucocorticoid-free complete remission(At Week 26/52)
研究者
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