An Early Phase 2 Clinical Study of KSP-0243

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Criteria

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,