An Early Phase 2 Clinical Study of KSP-0243

Last updated: March 12, 2025
Sponsor: Kissei Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

KSP-0243

Placebo

Clinical Study ID

NCT05831670
0243CT02
  • Ages 18-74
  • All Genders

Study 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.

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

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: KSP-0243
Phase: 2
Study Start date:
April 27, 2023
Estimated Completion Date:
October 18, 2024

Connect with a study center

  • Research Site

    Multiple Locations,
    Japan

    Site Not Available

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