NL-OMON53376招募中不适用
A double-blind, randomized, placebo-controlled, phase 2a study to evaluate the safety, tolerability, and pharmacodynamic (PD) effects of two infusions of escalating doses of TPM502 in adults diagnosed with celiac disease (CeD) - TPM502 in adults diagnosed with celiac disease (CeD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
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 64（—）
入选标准
- •1. Availability of a documented biopsy-confirmed diagnosis of CeD OR documented
- •tissue transglutaminase >10x upper limit of normal (ULN) and documented
- •positive immunoglobulin A (IgA) anti-endomysial antibody (EMA) at time of CeD
- •diagnosis (as per local guidelines) 2. Serum anti-tissue transglutaminase 2
- •immunoglobin A antibodies within normal range at screening 3. Serum IL-2 levels
- •(AUC1-6h) > 2x AUC1-6h at the lower level of quantification (LLOQ) (i.e., 8x
- •LLOQ) following the GC at screening 4. Patients must have been on gluten-free
- •diet (GFD) for >= 6 months 5. Patients must have well-controlled CeD, defined as
- •mild or with no ongoing signs or symptoms felt to be related to active CeD, as
- •per investigator`s assessment 6. Human leukocyte antigen (HLA)-DQ2.5 positive
- •(homozygous and heterozygous) but HLA-DQ8 and HLA-DQ2.2 negative
排除标准
- •1. Known or suspected refractory CeD (refractory CeD type I or II)
- •2. Known intolerable symptoms following previous GCs, as per investigator`s
- •3. Treatment with systemic immunosuppressants (e.g., glucocorticoids), ongoing
- •or administered in the 12 weeks preceding the first investigational medicinal
- •product (IMP) administration
研究者
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