NCT06979531进行中（未招募）2 期
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 334
- 主要终点
- Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
研究概览
简要总结
This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).
详细描述
The primary objective is to evaluate the efficacy, safety, and tolerability of IMVT-1402 compared to placebo, as measured by the change from baseline of Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) at Week 24.
The total duration of study participation is expected to be up to 105 weeks for an individual participant.
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, Investigator, Outcomes Assessor)
盲法说明
The Sponsor will also be blinded in the study.
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.
- •Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.
- •Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
- •Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL/min) at the Screening Visit.
- •Additional inclusion criteria are defined in the protocol.
排除标准
- •Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations.
- •Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.
- •Additional exclusion criteria are defined in the protocol.
研究组 & 干预措施
Group 1: IMVT-1402 Dose 1
Experimental
干预措施: IMVT-1402 (Drug)
Group 2: IMVT-1402 Dose 2
Experimental
干预措施: IMVT-1402 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
时间窗: Baseline and at Week 24
The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.
次要结局
- Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo(Week 24)
- Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo(Week 48)
- Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo(Week 48)
- Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo(Week 24)
- Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo(Baseline, Week 24)
- Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo(Baseline and at Week 24)
- Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo(Baseline and at Week 24)
研究者
研究点 (334)
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