NCT07298343进行中（未招募）2 期
A Phase II, Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Efficacy and Tolerability of ZED1227 in Celiac Disease Subjects Experiencing Symptoms Despite Gluten-free Diet
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Change in CDSD GI Specific Symptom Score
研究概览
简要总结
A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Men or women between 18 and 80 years of age, inclusively
- •Documented initial biopsy-proven diagnosis of celiac disease or, in case of missing histological documentation, TG2-IgA > 10 x upper limit of normal (ULN) at diagnosis at least 12 months prior to V0
- •Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0
- •Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
排除标准
- •Presence of hypo- or hyperthyroidism. A patient with a well-controlled thyroid disorder during the previous 3 months can be included
- •Patients diagnosed to have confirmed refractory celiac disease type I (RCDI) or II (RCDII), with the exception that patients with a diagnosis of RCDI can be considered for inclusion if they do not have clear signs of T cell monoclonality or atypical T cells (e.g., as revealed by CD3/CD8 immunohistochemistry) and if they do not present with very severe symptoms and/or parameters of significant malabsorption and if they have not received prior treatment with immunosuppressants such as budesonide or azathioprine,
- •Severe complications of celiac disease
- •Concomitant diseases of the intestinal tract in addition to celiac disease, such as Crohn's disease, ulcerative colitis, other forms of inflammatory bowel disease, severe irritable bowel syndrome, microscopic colitis, small intestinal bacterial overgrowth (SIBO), exocrine pancreatic insufficiency; any other active diseases of the intestinal tract (e.g., active, untreated peptic ulcer, esophagitis, gastroesophageal reflux disease) that might, in the investigator's opinion, interfere with assessment of symptoms of abdominal pain, diarrhoea, or other components of celiac disease
- •History or presence of dermatitis herpetiformis
研究组 & 干预措施
low Dose 1 ZED1227 + SIGE
Experimental
干预措施: ZED1227 + SIGE (Drug)
Placebo + SIGE
Placebo Comparator
干预措施: Placebo (Other)
medium Dose ZED1227 + SIGE
Experimental
干预措施: ZED1227 + SIGE (Drug)
high dose ZED1227 + SIGE
Experimental
干预措施: ZED1227 + SIGE (Drug)
low Dose 2 ZED1227 + SIGE
Experimental
干预措施: ZED1227 + SIGE (Drug)
结局指标
主要结局
Change in CDSD GI Specific Symptom Score
时间窗: 12 weeks
次要结局
- Change in PRO: Change from baseline in the percentage of Symptom Free Days (SFD)(V5 (Wk 15) over a 14-day period)
- Histological assessment of villous height to crypt depth ratio (VH:CrD)(15 weeks)
- Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea)(12 weeks)
- Change in duodenal mucosal inflammation measured as the density of CD3positive intraepithelial lymphocytes (IELs)(15 weeks)
- Proportion of subjects with histologic non-worsening, defined as change in VH:CrD ≥ 0(15 weeks)
- Change in serological markers TG2-IgA, TG2-IgG, DGP-IgA, DGP-IgG, and EmA-IgA(12 weeks)
研究者
研究点 (1)
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