EUCTR2020-003556-33-PL进行中（未招募）1 期
A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must satisfy all the following criteria at the screening visit, unless otherwise stated:
- •1. Male or female, of any race, =18 and =60 years of age.
- •a. Females will not be pregnant or lactating.
- •b. Females of childbearing potential will agree to abide by the contraception requirements from the time of signing the informed consent form (ICF) until 3 months after the last dose of study drug.
- •c. Males will agree to abide by the contraception requirements from Day 1 until 3 months after the follow-up visit.
- •2. Have been diagnosed with active UC for =3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
- •3. Have a total Mayo score =6, an endoscopic subscore =2, rectal bleeding subscore =1, and a stool frequency subscore =1, regardless of standard of care history.
- •4. Able to comprehend and willing to voluntarily sign an ICF and to abide by the study restrictions.
- •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 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from the study if they satisfy any of the following criteria at the screening visit, unless otherwise stated:
- •1. Have received:
- •a. intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or
- •b. Janus kinase (JAK) inhibitors within 2 weeks, or
- •c. cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or
- •d. anti-TNF-a biologics within 9 weeks, or
- •e. any other biologics (including ustekinumab and vedolizumab) for the treatment of UC within 12 weeks.
- •2. Have received orally administered azathioprine or 6-mercaptopurine that has been stable for <8 weeks. Doses of oral drugs must remain stable until the last dose of study drug.
- •3. Have received orally administered 5-aminosalicylic acid, sulphasalazine, or low-dose corticosteroids (prednisolone =20 mg/day or equivalent) that have been stable for <5 weeks. Doses of oral drugs must remain stable until the last dose of study drug.
- •4. Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for <7 days or 5 half-lives, whichever is longer.
- •5. Have Crohn’s disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic (as determined by the investigator) pancolitis, confined proctitis (distal, =15 cm), or symptomatic intestinal stenosis.
- •6. Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC.
- •7. Have an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •8. Have a positive test for Clostridium difficile, or have evidence of treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to Day 1.
- •9. Have active infection with the human immunodeficiency virus or hepatitis B or C viruses.
- •10. Have clinically significant active extraintestinal infection (eg, pneumonia, pyelonephritis).
- •11. Have, in the opinion of the investigator, clinically significant abnormal vital signs, physical examination findings, or 12-lead electrocardiograms (ECGs) at screening or Day 1.
- •12. Have a history of any disease or condition (including mental and emotional conditions) that, in the opinion of the investigator (or designee), would affect participation in this study.
- •13. Have clinically significant abnormal liver function tests, including:
- •a. estimated glomerular filtration rate =50 mL/min/1.73m2
- •b. alanine aminotransferase or aspartate aminotransferase >2 × the upper limit of normal (ULN)
- •c. direct bilirubin >1.5 ULN.
- •Note: Liver function tests may be repeated once, at the discretion of the investigator (or designee).
- •14. Have other clinically significant abnormal clinical laboratory results that, in the opinion of the investigator, preclude participation in the study, including:
- •a. platelet count <100,000/µL
- •b. haemoglobin <8.5 g/dL
- •c. neutrophils <1500/µL
- •d. lymphocytes <500/mm3
- •e. absolute white blood cells count <3000/µL.
- •Note: Clinical laboratory evaluations may be repeated once, at the discretion of the investigator (or designee).
- •15. Have participated in a clinical study involving administration of an investigational drug in the past 30 days prior to Day 1.
- •16. Have previously participated in any study of BBT-401-1S.
- •17. In the opinion of the investigator (or designe
研究者
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