CTIS2023-507240-37-00招募中1 期
KAN-101-03: A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease - KAN-101-03
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Adults aged 18 to 70 years inclusive., Previously documented diagnosis of CeD based on positive serology (eg, tissue transglutaminase IgA antibody and/or DGP IgG) AND intestinal histology consistent with = Marsh Type II or with evidence of villous atrophy., HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)., Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening., Have followed a gluten-free diet for =12 months immediately prior to study entry (self-reported)., Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher.
排除标准
- •Refractory CeD, defined as severe persistent or recurrent malabsorptive signs or symptoms with substantial villous atrophy (eg, documented Marsh score 3c in source data) despite strict adherence to a GFD for at least 12 months in absence of other disorders., Previous treatment with tolerance-inducing therapies for CeD., Selective IgA deficiency., Positive for HLA-DQ8 genotype (DQA1*03, DQB1*0302) even if DQ2.5 is also present., Known wheat allergy., Diagnosis of type-I diabetes., History of dermatitis herpetiformis., Pregnant or breastfeeding., Known history of severe hypersensitivity reactions or anaphylaxis to gluten., Active gastrointestinal disease other than CeD (eg, inflammatory bowel disease, any forms of colitis except well-controlled microscopic colitis, uncontrolled IBS, peptic ulcer disease, eosinophilic esophagitis, and active GI infections).
研究者
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