NCT04614571已完成不适用
TCR Sequencing and Transcriptional Profiling in Celiac Disease Patients Undergoing Gluten Challenge
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from Baseline in peripheral blood TCR repertoire
研究概览
简要总结
The primary objectives are:
- Characterize the T cell receptor (TCR) repertoire in duodenal biopsy samples of participants pre- and post-challenge.
- Compare for each patient the TCR repertoire of duodenal biopsy samples with the peripheral blood TCR repertoire of each study participant
- Characterize the transcriptome of duodenal biopsy samples and blood from study participants pre- and post-challenge
The secondary objectives are:
- Ex vivo identification and validation of DQ-restricted gliadin specific TCRs.
- Characterize the gluten-challenge induced changes in small intestine histology using standard for Celiac Disease (CeD) histological assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI) ≥17 and ≤40 kg/m2 and a body weight >45 kg at the Screening Visit
- •Be judged to be in good health as defined in the protocol
- •Have well-controlled biopsy-proven CeD, compliant with a GFD for ≥6 months preceding Screening as defined in the protocol
- •Be HLA-DQ2 and/or HLA-DQ8 positive as defined in the protocol
排除标准
- •Have a history of gluten triggered acute symptoms (≤24 hours after gluten exposure), and/or severe symptoms (abdominal pain interfering with daily activities, diarrhea with >5 stools/day), and/or prolonged symptoms (duration >7 days)
- •Have a history of clinically significant endocrine, cardiovascular, hematological, hepatic, immunological (other than CeD or autoimmune thyroid disease), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or disease
- •Have participated in another investigational trial within 4 weeks before Screening
- •Have a history of cancer (malignancy) other than nonmelanoma skin cancer
- •Have a history of significant multiple and/or severe allergies (e.g., latex allergy)
- •Presence of HIV (HIV Ab), hepatitis B (HBsAg, HBAb) or Hepatitis C (HCV Ab) seropositivity at screening
- •Ongoing immunosuppression or receive any treatment that might alter T cell repertoire or phenotype
- •Note: Other protocol-defined inclusion/ exclusion criteria apply
结局指标
主要结局
Change from Baseline in peripheral blood TCR repertoire
时间窗: Up to 30 days post challenge
Change in the T-cell receptor repertoire (measured by T cell receptor sequencing) in peripheral blood after gluten challenge
Changes from baseline in small intestine and peripheral blood transcriptome
时间窗: Up to 30 days post challenge
Change in the gene expression profile (transcriptomic analysis by ribonucleic acid \[RNA\] sequencing and cellular indexing of transcriptomes and epitopes by sequencing \[CITEseq\]) of the small intestine and peripheral blood after gluten challenge
Change from Baseline in small intestine TCR repertoire
时间窗: Up to 30 days post challenge
Change in the T-cell receptor repertoire (measured by T cell receptor sequencing) in the small intestine after gluten challenge
次要结局
- Change from Baseline in Small Intestine Histology Based on Villous Height (Microns), Crypt Depth (Microns) and Villous Height to Crypt Depth Ratio (Vh:Cd)(Baseline and Day 15)
- Identification and ex vivo functional validation of gluten-specific T cells(Up to 30 days post challenge)
- Change from Baseline in Small Intestine Histology Based on Intraepithelial Lymphocytes (IEL) Count per 100 epithelial cells(Baseline and Day 15)
研究者
研究点 (2)
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