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临床试验/EUCTR2020-005438-14-PL
EUCTR2020-005438-14-PL招募中1 期

A Phase 2, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet

Takeda Development Center Americas, Inc.0 个研究点目标入组 377 人开始时间: 2022年10月14日最近更新:
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适应症

试验速览

阶段
1 期
状态
招募中
入组人数
377
研究概览入排标准研究者记录与标识符相似试验

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. The subject is able to provide written informed consent form to participate in the study before completing any study-related procedures.
  • •2. In the opinion of the investigator, the subject is willing and fully capable of understanding and complying with study procedures including PRO compliance and restrictions defined in this protocol.
  • •3. The subject has an adequate comprehension of a GFD assessed by completion of a knowledge test after viewing of educational materials.
  • •4. The subject has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to
  • •gluten exposure. The CeD-related symptoms may vary day-by-day as long as the severity of at least 1 symptom is moderate or greater. The subjects must meet symptom criteria to undergo EGD/VCE.
  • •5. The subject has biopsy-confirmed CeD-or, in subjects with CeD without a producible initial biopsy report, the following additionalinclusion criteria must be met:
  • •a) Serology (IgA-tTg) at diagnosis or subsequent visit must be at least 2
  • •times the ULN.
  • •b) Histology at screening biopsy at Week -4 must be consistent with
  • •Marsh-Oberhuber score of 2 or greater as read by a central pathologist.
  • •6. The subject has been attempting to maintain a GFD for at least 12 months as self-reported by the subject.
  • •7. The subject has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <2.5 at Week -4.
  • •8. The subject is HLA-DQ2 and/or HLA-DQ8 positive.
  • •9. The subject in Cohort 1 is aged 18 to 75 years, inclusive, at the time of signing the informed consent form.
  • •10. The subject in Cohort 2 is aged 12 to 75 years, inclusive, at the time of signing the informed consent/pediatric assent forms.
  • •11. The subject is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator.
  • •12. The subjects must have a body mass index (BMI) between 16 and 40, inclusive.
  • •13. The subject is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the screening visit (Visit 1). There should be no changes to diet, medications (prescription or over-the-counter) or supplements during study participation.
  • •14. A male subject who is nonsterilized* and sexually active with a female partner of childbearing potential* agrees to use highly effective method of contraception (eg, condom with or without spermicide)* from signing of informed consent/pediatric assent forms throughout the duration of the study and for 100 days after last dose of study drug.
  • •15. A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agrees to use a highly effective method of contraception* from signing of informed consent/pediatric assent forms throughout the duration of the study and for 40 days after the last dose of study drug.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 21
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 351
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 5

排除标准

  • •1. The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  • •2. The subject has inadequate renal or hepatic function before randomization based on the following laboratory parameters:
  • •- Total bilirubin =1.5 × ULN unless the subject has known Gilbert’s syndrome that can explain the elevation of bilirubin, or
  • •- Serum alanine aminotransferase (ALT) or aspartate aminotransferase
  • •(AST) =3 × ULN.
  • •- Creatinine >1.5 × ULN.
  • •3. The subject has the presence of other inflammatory GI disorders or systemic autoimmune diseases (including but not limited to the following: inflammatory bowel disease, eosinophilic esophagitis, gastroenteritis or colitis, microscopic colitis diagnosed at screening or requiring treatment in the 6 months before screening, scleroderma, psoriatic or rheumatoid arthritis,lupus) other than those noted below:
  • •- Thyroid disease that has been well-controlled for at least 6 months.
  • •- Well-controlled type 1 diabetes (glycosylated hemoglobin <8 and no hospitalization or emergency room visit in the last 12 months for hyperglycemia or hypoglycemia).
  • •4. The subject has ongoing systemic immunosuppressant, systemic corticosteroid treatment excluding medication given for endoscopies, or treatment with systemic immunosuppressants or systemic corticosteroids in the 12 weeks before screening.
  • •- The subject is receiving immunosuppressive doses of corticosteroids: 3 mg per day or more of budesonide for more than 3 consecutive days within 3 months before screening, more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months before the first dose, any dose of oral or IV corticosteroids within 30 days of the first dose, or high-dose inhaled corticosteroids (>960 µg/day of beclomethasone dipropionate
  • •or equivalent), or other systemic immunosuppressive agents.
  • •5. The subject has ongoing use of over-the-counter digestive enzymes or digestive supplements,other than lactase, including those for gluten digestion. Probiotics are allowable if they were started before screening and not discontinued or changed in dose or type during the study.
  • •6. The subject has an inability to swallow the study drug tablet.
  • •7. The subject has completed the CDSD on =75% of the days during Week -8 until randomization.
  • •8. If more than 10% of planned enrollment in a cohort report a greater than 1 point improvement in PGIS during the SIGE run-in period (Week -2 through Day -1), further subjects showing this degree of improvement will be excluded from the cohort.
  • •9. The subject has ongoing symptoms that are considered by the investigator to be due to other GI conditions, including irritable bowel syndrome and eosinophilic disorders.
  • •10. The subject has active microscopic colitis requiring treatment in the 6 months before screening.
  • •- Microscopic colitis detected at screening if sigmoidoscopy is performed would exclude the subject.
  • •11. The subject has known or suspected type 2 refractory CeD or ulcerative jejunitis.
  • •12. The subject has ongoing chronic use (defined as >7 days continuous use) of a nonsteroidal anti-inflammatory drug aside from <100 mg aspirin, daily, for prophylactic use.
  • •13. The subject has ongoing use, or use in the 3 months before screening, of medications known to cause villous abnormalities (eg, mycophenolate mofetil, angiotensin receptor blockers,

研究者

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