An early phase 2 clinical study of KSP-0243

JRCT ID: jRCT2031220717

Registered date:20/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 09/03/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): KSP-0243 tablets or Placebo tablets will be orally administered.

Outcome(s)

• Primary Outcome: Clinical response rate based on the modified Mayo score at Week 8

Secondary Outcome

- Clinical remission rate based on the modified Mayo score at Week 8
- Clinical response rate based on the full Mayo score at Week 8
- Clinical remission rate based on the full Mayo score at Week 8
- Incidence of adverse events (AE) and adverse drug reactions (ADR)
- Measured values and fluctuations in laboratory tests (hematology, blood chemistry, and urinalysis) at each time point
- Measured values and fluctuations in vital signs (blood pressure, pulse rate, and body temperature) measured at each time point
- Measured values and fluctuations in body weight at each time point
- Changes from baseline, measured values, fluctuations and any abnormal findings in 12-lead electrocardiogram (ECG) parameters, measured value at assessment time points in each time point
- KSP-0243 concentration in plasma at each time point
- KSP-0243 concentration in colorectal mucosa at Week 8

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 74age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shimizu Yoshitaka
• Secondary ID(s): NCT05831670