ISRCTN79155276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
Dr Falk Pharma (Germany)0 个研究点目标入组 138 人开始时间: 2024年3月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
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
- •1. Signed informed consent
- •2. Men or women between 18 and 80 years of age, inclusively
- •3. Documented initial biopsy-proven diagnosis of coeliac 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
- •4. Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0
- •5. Human leukocyte antigen DQ (HLA-DQ) typing compatible with coeliac disease
- •6. 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 A and last 3 weeks prior to Baseline Visit B as a GI total mean symptom score (measured using CDSD) for the worst 25% of the days of = 2 on a 5-point scale
- •7. Biopsy showing VH:CrD ratio of = 2.5 from distal duodenum biopsies in Trial Period A
- •8. Negative diagnosis of Helicobacter pylori infection and no history of eradication within the last 2 months before biopsy sampling in Trial Period A
- •9. BMI between 17.0 and 35 kg/m², inclusively
- •10. Willingness to follow her/his usual dietary patterns, including eating at restaurants and others’ homes during the trial
- •11. Willingness to maintain current GFD throughout participation in the trial
- •12. Negative pregnancy test in female subjects under 60 years of age at Screening Visit and Baseline Visit B
- •13. Women of child-bearing potential should use a highly effective method of birth control which is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptive pills, combined contraceptive patches and vaginal rings, copper-containing intrauterine devices, sexual abstinence or vasectomised partner. The investigator is responsible for determining whether the subject has adequate birth control for trial participation
排除标准
- •1. Presence of hypo- or hyperthyroidism. A patient with a well-controlled thyroid disorder during the previous 3 months can be included.
- •2. Patients diagnosed with confirmed refractory coeliac disease type I (RCDI) or II (RCDII), with the exception that patients with a diagnosis of RCDI can be included if they don’t have clear signs of T cell monoclonality or atypical T cells (e.g., as revealed by CD3/CD8 immunohistochemistry) & if they don’t present with very severe symptoms &/or parameters of significant malabsorption & if they haven’t received prior treatment with immunosuppressants e.g. budesonide or azathioprine.
- •3. Severe complications of coeliac disease
- •4. Concomitant diseases of the intestinal tract, e.g. Crohn’s disease, ulcerative colitis, severe irritable bowel syndrome, microscopic colitis, small intestinal bacterial overgrowth, exocrine pancreatic insufficiency
- •5. History/presence of dermatitis herpetiformis.
- •6. History/presence of neurological disorders like ataxia or neuropathy
- •7. Any severe concomitant cardiovascular, renal, endocrine (type 1 diabetes mellitus with HbA1C >8% / 64 mmol/mol or hospitalisation or emergency visit for hyperglycaemia or hypoglycaemia within 12 months of screening), or psychiatric disorder or other disease.
- •8. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit. Patients with basal cell carcinoma of the skin completely resected can be included.
- •9. Evidence of relevant systemic disease (e.g., active tuberculosis)
- •10. Abnormal hepatic function [alkaline aminotransferase (ALT) or alkaline phosphatase (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/intravenous) corticosteroids or immunomodulators (e.g., glucocorticoids, cyclosporine, methotrexate, anti-TNF-a therapy, anti-integrin therapy, Janus kinase inhibitors), high dose inhaled corticosteroids during the past 3 months before V0.
- •13. Continuous intake of drugs with suspicion of impact on villous atrophy, e.g.
- •14. Alcohol use > 12 g/d for women, >24 g/d for men within the past 12 months before screening.
- •15. Dual antiplatelet therapy or oral anticoagulants
- •16. Unwillingness to undergo gastrointestinal endoscopy with biopsy as required per protocol
- •17. Unwillingness to ingest SIGE bars
- •18. Allergies to SIGE bar nongluten ingredients (tapioca syrup, oats, almonds, rice crisp, chocolate, almond butter, cocoa butter, oat flour, glycerine, sunflower lecithin, salt, & natural flavours) or significant symptoms on eating the gluten-free SIGE bar
- •19. Known hypersensitivity reaction &/or allergy, including anaphylaxis, to wheat &/or gluten
- •20. If more than 10% of planned enrolled subjects report a greater than 1 point improvement in PGI-S during Trial Period A, further subjects with >1 point improvement in PGI-S will be excluded
- •21. Known intolerance/hypersensitivity/resistance to the study drug & excipients or drugs of similar chemical structure/pharmacological profile.
- •22. Doubt about the subject’s cooperation, e.g., because of addiction to alcohol or drugs
- •23. Existing or intended pregnancy or breastfeeding
- •24. Affiliation with the investigator or persons working at the study sites or subject who is employed by the Sponsor
- •25. Subjects who are institutionalised because of legal/regulatory order
- •26. Participation in another trial of a therapeutic who received IMP within the last 30 days prior to V0
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