Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
KSP-0243
Placebo
Clinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients aged 18 to 74 years old (both inclusive)
Patients who have been given the diagnosis of ulcerative colitis for at least 12weeks
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 certainconditions
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 thestart of the screening period
Exclusion
Exclusion Criteria:
Patients who underwent an enterectomy or are expected to require an enterectomyduring the study period (except appendectomy)
Patients who have or suspected to have bacterium- or parasite-induced infectiousenteritis (e.g., infection with Clostridium difficile)
Patients with any of the following concomitant illnesses with the severityconsidered inappropriate as a study patient by the principal investigator or thesubinvestigator or medical history thereof:
Hepatic or renal disorders or cardiovascular, endocrine, metabolic, pulmonary,gastrointestinal, neurological, urological, genitourinary, and immune diseases,
Study Design
Connect with a study center
Research Site
Multiple Locations,
JapanSite Not Available
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