An early phase 2 clinical study of KSP-0243
- Conditions
- lcerative colitis
- Registration Number
- JPRN-jRCT2031220717
- Lead Sponsor
- Shimizu Yoshitaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method