NCT05831670CompletedPhase 2
An Early Phase 2 Clinical Study of KSP-0243
An Early Phase 2 Clinical Study of KSP-0243 in Patients With Mild to Moderate Active Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 2 Mar 2023
- Start date
- 27 Apr 2023
- Primary completion date
- 18 Oct 2024
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Diseases
- Ulcerative colitis
- NCT number
- NCT05831670
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 108
- From 27 Apr 2023 to the primary completion date, 18 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
Other illness
- Patients who have or suspected to have bacterium- or parasite-induced infectious enteritis (e.g., infection with Clostridium difficile)
- Hepatic or renal disorders or cardiovascular, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, genitourinary, and immune diseases,
Other
- Patients who underwent an enterectomy or are expected to require an enterectomy during the study period (except appendectomy)
Who the study is looking for
- 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
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Multiple Locations | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.