An Early Phase 2 Clinical Study of KSP-0243 (NCT05831670) | Clinical Trial Compass
CompletedPhase 2
An Early Phase 2 Clinical Study of KSP-0243
Japan108 participantsStarted 2023-04-27
Plain-language summary
A phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study to administer KSP-0243 or a placebo once daily after breakfast for 8 weeks in 100 patients with mild to moderate active ulcerative colitis.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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,
What they're measuring
1
Clinical response rate based on the modified Mayo score at Week 8