NCT07845955尚未招募2 期
INhibiting JAK1 to Save Pancreatic Islet Function in Recently Established T1D(INSPIRE-T1D)
Huijie Zhang1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2026年9月30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
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change from baseline in MMTT-stimulated C-peptide AUC at Week 52
研究概览
简要总结
This is a double-blind, randomized, placebo-parallel-controlled, multicenter study. The objective is to evaluate the efficacy and safety of Ivarmacitinib 8 mg administered for 52 weeks in preserving pancreatic β cell function in subjects with newly-onset type 1 diabetes mellitus. The study consists of a screening period (V1, up to 2 weeks), a 52-week double-blind treatment period (V2 to V14), and a 4-week safety follow-up period (V15).
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
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of type 1 diabetes mellitus.
- •Able to complete randomization and initiate treatment with the study drug within 100 days of being formally diagnosed with type 1 diabetes.
- •Peak stimulated C-peptide level ≥ 0.2 pmol/mL during the mixed-meal tolerance test performed in the screening period.
- •Tested positive for at least one type 1 diabetes-associated autoantibody.
排除标准
- •Presence of any autoimmune disease other than type 1 diabetes mellitus, except for stable autoimmune thyroid disease.
- •Presence of active infection and/or fever.
- •Known current or prior infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), or serological evidence of such infection at screening.
- •Active pulmonary tuberculosis, malignancy, etc.
- •Severe hepatic impairment (AST or ALT >3 × upper limit of normal), or severe renal impairment or end-stage renal disease (eGFR < 30 mL/min/1.73 m²).
- •Prior exposure to immunomodulatory agents, including baricitinib, ivarmacitinib, IL-1 receptor antagonists, tocilizumab (anti-IL-6 monoclonal antibody), infliximab (anti-TNF-α monoclonal antibody), interferons, etc.
- •Severe cardiovascular disease such as angina pectoris, myocardial infarction, or stroke within the previous 6 months.
- •Severe gastrointestinal disease.
- •Surgical procedure performed within the past 6 months.
- •Medical, psychological, or social conditions that, in the opinion of the investigator, may interfere with trial safety or proper completion.
研究组 & 干预措施
Placebo control group
Placebo Comparator
干预措施: Placebo (Drug)
Ivarmacitinib 8 mg group
Experimental
干预措施: Ivarmacitinib (Drug)
结局指标
主要结局
Change from baseline in MMTT-stimulated C-peptide AUC at Week 52
时间窗: From Baseline to Week 52
Change from baseline in C-peptide area under the curve (AUC) during a mixed-meal tolerance test (MMTT) after 52 weeks of treatment.
次要结局
- Change from baseline in MMTT-stimulated C-peptide AUC at Week 26(From Baseline to Week 26)
- Change from baseline in HbA1c at Week 52(From Baseline to Week 52)
- Change from baseline in daily insulin dose at Week 52(From Baseline to Week 52)
- Change from baseline in TIR assessed by CGM at Week 52(From Baseline to Week 52)
- Cumulative severe hypoglycemic events from baseline to Week 52(From Baseline to Week 52)
- Change from baseline in lymphocyte subpopulation quantified by flow cytometry at week 52(From Baseline to Week 52)
研究者
Huijie Zhang
Chief Physician
Shanghai Zhongshan Hospital
研究点 (1)
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