NCT06982963招募中2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of FB102 in Adult Participants With Celiac Disease on a Gluten Free Diet
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in the VCIEL
研究概览
简要总结
This study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 70 years at Screening.
- •Has documented diagnosis of CeD confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening (intestinal biopsy and serology do not have to be performed concurrently).
- •Body mass index (BMI) between 16.0 and 40.0 kg/m2, inclusive.
- •Self-reported to be on a GFD for at least 12 months prior to Screening and must be willing to remain on a GFD for the duration of study participation, with the exception of the oral gluten challenge administered as a study procedure. Prior acute and resolved accidental exposures are not exclusionary.
排除标准
- •Uncontrolled CeD and/or active signs/symptoms of CeD, in the opinion of the Investigator.
- •History of or current neuropsychiatric manifestations specifically related to gluten exposure including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, and depression.
研究组 & 干预措施
A
Experimental
FB102
干预措施: FB102 (Biological)
B
Experimental
FB102
干预措施: FB102 (Biological)
C
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in the VCIEL
时间窗: 78 Days
Vh:Cd and IEL Composite Scale (VCIEL)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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