NCT07239336招募中2 期
A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate The Efficacy and Safety of DONQ52 in Active Celiac Disease Patients Who Have Duodenal Mucosal Damage and Persistent Symptoms Despite Attempting A Gluten-free Diet (DAISY STUDY)
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
- 92
- 试验地点
- 74
- 主要终点
- Change in Villous Height to Crypt Depth Ratio (Vh:Cd)
研究概览
简要总结
The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of 18 to 40 (kg/m2) at screening.
- •Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol.
- •History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD
- •Attempting a GFD for at least 12 months prior to the screening visit.
- •- The participants should be instructed not to alter dietary habits including a GFD during the study period.
- •Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygous or heterozygous).
- •Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening.
- •Willingness to undergo 2 on-study upper gastrointestinal endoscopies with duodenal biopsies.
- •Presence of ongoing duodenal mucosal damage defined as Vh:Cd of 2.5 or less
排除标准
- •Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator.
- •History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin).
- •History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever.
- •History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.
- •Participants who carry the HLA-DQ8 (HLA-DQA1*03 and DQB1*0302) genotype (homozygous or heterozygous).
- •Any other chronic, active gastrointestinal disease (e.g., inflammatory bowel disease, microscopic colitis, eosinophilic esophagitis, peptic ulcer, gastroesophageal reflux disease, functional dyspepsia, or irritable bowel syndrome) that might in the investigator's opinion, interfere with the assessment of GI symptoms or small intestinal histology.
- •Helicobacter pylori tests that indicate current infection.
- •Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening.
- •Positive hepatitis B surface antigen (HBsAg) test or total hepatitis B core (HBc) antibody test at screening.
- •Positive hepatitis C virus (HCV) antibody test at screening, except in participants who have negative results for HCV ribonucleic acid (RNA) test at screening.
- •Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.
研究组 & 干预措施
Placebo + SIGE Gluten capsule
Placebo Comparator
Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
干预措施: Placebo DONQ52 (Drug)
Placebo + SIGE Gluten capsule
Placebo Comparator
Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
干预措施: Simulated Inadvertent Gluten Exposure (SIGE) capsule (Dietary Supplement)
DONQ52 + SIGE Gluten capsule
Experimental
DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
干预措施: Simulated Inadvertent Gluten Exposure (SIGE) capsule (Dietary Supplement)
DONQ52 + SIGE Gluten capsule
Experimental
DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
干预措施: DONQ52 (Drug)
结局指标
主要结局
Change in Villous Height to Crypt Depth Ratio (Vh:Cd)
时间窗: Baseline to Week 27
The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. The difference in the adjusted mean change from baseline (Run-in) to Week 27 in Vh:Cd between DONQ52 and placebo groups will be estimated using the analysis of covariance (ANCOVA) method. A negative change from baseline indicates worsening disease.
次要结局
- Change in Average of total score of Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) domain (abdominal pain, diarrhea, nausea, and bloating) calculated as two-week average.(Baseline to Week 27)
- Change in Average of the total score of non-stool GI symptoms (abdominal pain, nausea, and bloating) calculated as two-week average.(Baseline to Week 27)
- Change in Average of diarrhea frequency score as assessed by CDSD frequency supplement calculated as two-week average.(Baseline to Week 27)
- Prevalence of anti-drug antibodies (ADAs) to DONQ52.(Day1 to 47 weeks)
- Relationship between the total score of CDSD GI domain and Patient Global Impression of Severity (PGI-S) or Patient Global Impression of Change (PGI-C).(Baseline to 47 weeks)
- Incidence and severity of adverse events (AEs) and their causal relationship to the investigational medicinal products (IMPs).(Baseline to 47 weeks)
- Serum DONQ52 concentration.(Day1 to 47 weeks)
- Incidence of anti-drug antibodies (ADAs) to DONQ52.(Day1 to 47 weeks)
研究者
研究点 (74)
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