An early phase 2 clinical study of KSP-0243 in patients with mild to moderate active ulcerative colitis

Shimizu Yoshitaka0 个研究点目标入组 100 人开始时间: 2023年3月20日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•Patients aged 18 to 74 years old (both inclusive)
•- Patients who have been given the diagnosis of ulcerative colitis for at least 12 weeks
•- Patients with an endoscopic view typically seen with ulcerative colitis spreading > 15 cm from the anal verge
•- Patients with mild to moderate active ulcerative colitis who meet the certain conditions
•- Patients who have an inadequate response to a fixed-dose oral 5-ASA formulation (mesalazine or salazosulfapyridine) continued from at least 2 weeks prior to the start of the screening period

•- Patients who underwent an enterectomy or are expected to require an enterectomy during the study period (except appendectomy)
•- Patients who have or suspected to have bacterium- or parasite-induced infectious enteritis (e.g., infection with Clostridium difficile)
•- Patients with any of the following concomitant illnesses with the severity considered inappropriate as a study patient by the principal investigator or the subinvestigator or medical history thereof:
•- Hepatic or renal disorders or cardiovascular, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, genitourinary, and immune diseases

发起方

Shimizu Yoshitaka