EUCTR2020-004612-97-PL招募中1 期
A phase IIb, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet - ZED1227 for treatment of symptomatic celiac disease subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 400
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
- 性别
- All
入选标准
- •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
- •At least one moderate or severe gastrointestinal symptom (i.e., diarrhoea, abdominal pain, bloating or nausea) during the last 4 weeks prior to Baseline Visit
- •Negative diagnosis of Helicobacter pylori infection
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 330
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •-Presence of hypo- or hyperthyroidism. A patient with a thyroid stimulating hormone (TSH) level up to 25% higher than ULN or up to 25% lower than the lower limit of normal (LLN) but with normal free
- •triiodothyronine (FT3) and free thyroxine (FT4) levels can be included in the trial. In addition, a patient with a well-controlled thyroid disorder during the previous 3 months can be included,
- •2.Subjects 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 IHC) 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,
- •3.Severe complications of celiac disease [e.g., enteropathy associated Tcell lymphoma (EATL), ulcerative jejunitis, perforation],
- •4.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,
- •5.History or presence of dermatitis herpetiformis,
- •6. History or presence of neurological disorders like ataxia or neuropathy (mild neuropathy, related or unrelated to celiac disease, is not a reason for exclusion),
- •7.Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder or other disease, which in the opinion of the investigator might have an influence on the subject's compliance or the interpretation of the results,
- •8.History of cancer in the last five years,
- •9.Evidence of relevant systemic disease (e.g., active tuberculosis),
- •10.Abnormal hepatic function (ALT or ALP > 2.5 x ULN), liver cirrhosis, or portal hypertension,
- •11.Glomerular filtration rate = 60 ml/min/1.73 m²,
- •12.Continuous intake of systemic (oral or intravenous) corticosteroids or immunomodulators (e.g., glucocorticoids, cyclosporine, methotrexate, anti-TNF-? therapy, anti-integrin therapy, Janus kinase inhibitors), high dose inhaled corticosteroids (> 1000 µg/d of beclomethasone dipropionate or equivalent) during the past 3 months before V0,
- •13.Continuous intake of drugs with suspicion of impact on villous atrophy, such as
- •proton-pump inhibitors (PPIs; permitted at a regular dose equivalent to 20-40 mg/day pantoprazol, esomeprazole or equivalent),
- •selective serotonin reuptake inhibitors [SSRIs1; low to medium dose (10-150 mg Fluvoxamine or equivalent dose of other SSRIs) permitted in case of long-term therapy (at least for 6 months)],
- •losartan (angiotensin II receptor blockers equivalent to 50 mg losartan permitted except for olmesartan forbidden at any dose), and
- •mycophenolate2,3 (forbidden at any dose) during the past 2 months before biopsy sampling in Trial Period A;
- •non-steroidal anti-inflammatory drugs (NSAIDs; maximal daily dose permitted 900 mg for ibuprofen, 500 mg for naproxen and 75 mg for diclofenac, except for one week before biopsy)
研究者
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