ISRCTN16847938已完成1 期
Randomized, double-blind, sponsor-open, phase 1b study to assess the safety, pharmacokinetics and to explore the pharmacodynamics of RO7486967 in patients with moderate to severe active ulcerative colitis
Roche (Switzerland)0 个研究点目标入组 19 人开始时间: 2021年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37962000/ (added 16/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Between the ages of 18 to 75 years (inclusive)
- •2. Diagnosis of UC at least 12 weeks prior to screening.
- •3. Participants with active moderate to severe ulcerative colitis as measured by partial >= MCS 3, with stool frequency subscore >=1, rectal bleeding subscore >=1, and fecal calprotectin >=150 mcg/g.
- •4. Most recent colonoscopy within the preceding 3 years at the time of screening.
- •5. Body mass index (BMI) within the range of 18-35 kg/m² (inclusive).
排除标准
- •1. Diagnosis of fulminant UC, Crohn’s disease or indeterminate colitis, microscopic colitis, segmental colitis associated with diverticulosis, ischemic colitis, or radiation-induced colitis based on medical history, endoscopy, and/or histological findings.
- •2. Active infections requiring systemic therapy with antibiotic, antiviral, or antifungal medication or febrile illness within 7 days before Day 1.
- •3. History of primary or acquired immunodeficiency.
- •4. History of chronic pulmonary disease with resultant clinically significant abnormal pulmonary function.
- •5. History of clinically significant cardiac or cardiovascular disease or uncontrolled hypertension.
- •6. Presence of chronic liver disease.
- •7. Evidence of colonic dysplasia that cannot be completely removed.
- •8. History of tuberculosis or a positive Quantiferon® Gold test.
- •9. History of clinically significant severe drug allergies, multiple drug allergies, or allergy to any constituent of the investigational medicinal product (IMP).
- •10. Lymphoma, leukemia, or any malignancy within the past 10 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years and in situ carcinoma of the cervix that was completely removed surgically.
- •11. History or presence of clinically significant ECG abnormalities before study drug administration (e.g., PQ/PR interval >=220 ms, QT corrected for heart rate using Fridericia’s correction factor (QTcF),<350 or >=450 ms) or clinically significant cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT interval syndrome, family history of sudden death).
- •12. Fecal microbiota transplant, defined as receipt of any product derived from the feces of another human and administered per oral, per nasogastric or nasoduodenal, or per rectum within the last 6 months.
- •13. Bowel surgery within 12 months prior to study start.
- •14. History of colectomy or partial colectomy.
- •15. History of known bleeding disorder or diseases with an increased risk of bleeding tendency.
研究者
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