A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Trial to Characterize the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease While Undergoing Oral Gluten Exposure
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 30
- 主要终点
- Change From Baseline in Villous Atrophy as Measured by Villous Height to Crypt Depth Ratio (Vh:Cd)
研究概览
简要总结
The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.
The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease.
A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease.
The expected trial duration per participant is approximately 86 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of celiac disease at least 12 months prior to screening
- •On a gluten-free diet for at least 12 months prior to screening
- •Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period
- •Male participants (including vasectomized) with women of child-bearing potential partners (whether pregnant or not) must use condoms and also agree not to donate sperm for the designated period
- •NOTE - Additional criteria apply, please contact the investigator for more information.
排除标准
- •A diagnosis or suspicion of refractory celiac disease
- •History of severe celiac-related symptoms following gluten exposure that require acute medical care or intervention of a health care professional
- •Any other gastrointestinal disease or condition that may interfere with the assessment of celiac disease
- •Current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma
- •Pregnant or lactating woman, or plans to become pregnant during the trial; any man who is considering fathering a child or donating sperm during the trial
- •A history of chronic alcohol or substance abuse disorder within the previous 2 years.
- •An active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening
- •Received or intends to receive any live vaccine within 4 weeks or any non-live vaccine 2 weeks prior to investigational medicinal product administration.
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
TEV-53408
干预措施: TEV-53408 (Drug)
结局指标
主要结局
Change From Baseline in Villous Atrophy as Measured by Villous Height to Crypt Depth Ratio (Vh:Cd)
时间窗: Baseline, Week 8
Vh:Cd is used to assess the severity of celiac disease. It is calculated by dividing the villous height by the crypt depth. A lower ratio indicates more damage.
Number of Participants With at Least One Treatment-Emergent Adverse Event
时间窗: Up to Week 28
Number of Participants With at Least One Treatment-Emergent Serious Adverse Event
时间窗: Up to Week 28
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest (PDAESI)
时间窗: Up to Week 28
Number of Participants Who Discontinued From the Study Due to an Adverse Event
时间窗: Up to Week 28
次要结局
- Change From Baseline in Intraepithelial Lymphocyte (IEL) Density(Baseline, Week 8)
- Change From Baseline in the VCIEL score(Baseline, Week 8)