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

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.

Study Overview

• Status: Completed
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Placebo; Drug: KSP-0243

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KSP-0243; Under double-blinding, KSP 0243 tablets will be orally administered.	Drug: KSP-0243; Oral administration
Placebo Comparator: Placebo; Under double-blinding, placebo tablets will be orally administered.	Drug: Placebo; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response rate based on the modified Mayo score at Week 8	The percentage of patients who satisfied both of the following requirements: Decreases in the modified Mayo score by ≥ 30% and ≥ 2 points from baseline; The rectal bleeding subscore based on the Mayo score decreases by ≥ 1 point from baseline or the subscore becomes ≤ 1 point	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission rate based on the modified Mayo score at Week 8	Clinical remission rate based on the modified Mayo score: The percentage of patients who satisfied all of the following requirements: The stool frequency subscore based on the Mayo score is 0 or 1 point with no aggravation from baseline; The rectal bleeding subscore based on the Mayo score is 0 points; The endoscopy subscore of the Mayo score is 0 or 1 point	Up to 8 weeks
Clinical response rate based on the full Mayo score at Week 8	Clinical response rate based on the full Mayo score: The percentage of patients who satisfied all of the following requirements.; Decreases in the full Mayo score by ≥ 30% and ≥ 3 points from baseline; The rectal bleeding subscore based on the Mayo score decreases by ≥ 1 point from baseline or the subscore becomes ≤ 1 point	Up to 8 weeks
Clinical remission rate based on the full Mayo score at Week 8	Clinical remission rate based on the full Mayo score: The percentage of patients who satisfied all of the following requirements.; Full Mayo score is ≤ 2 points; All the subscores are ≤ 1 point	Up to 8 weeks
Incidence of adverse events (AE) and adverse drug reactions (ADR)	- Adverse events, Adverse drug reactions	Up to 8 weeks
Laboratory tests (Hematology): Hemoglobin (g/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory tests (Hematology): Hematocrit (%)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory tests (Hematology): Erythrocyte (10^10/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Hematology): Leukocyte (10^6/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Hematology): Neutrophil (10^8/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Hematology): Eosinophil (10^8/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Hematology): Basophil (10^8/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Hematology): Monocyte (10^8/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Hematology): Lymphocyte (10^8/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Hematology): Platelet (10^10/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Na (mEq/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): K (mEq/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Cl (mEq/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Ca (mEq/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): P (mEq/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Creatinine (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Total Bilirubin (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Direct Bilirubin (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Indirect Bilirubin (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Total Protein (g/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Albumin (g/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): AST (U/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): ALT (U/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): γGTP (U/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): ALP (U/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Creatinine kinase (U/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Uric acid (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): BUN (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): LDH (U/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Total Cholesterol (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Triglyceride (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Amylase (U/L)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Blood chemistry): Glucose (mg/dL)	Summary statistics, scattered plots before and after the dose will be presented.; Shift tables before and after dose will be presented.	Up to 8 weeks
Laboratory test (Urinalysis): Protein	Number and percentage of subjects will be presented.; Shift tables before and after the dose will be presented.	Up to 8 weeks
Laboratory test (Urinalysis): Glucose	Number and percentage of subjects will be presented.; Shift tables before and after the dose will be presented.	Up to 8 weeks
Laboratory test (Urinalysis): Urobilinogen	Number and percentage of subjects will be presented.; Shift tables before and after the dose will be presented.	Up to 8 weeks
Laboratory test (Urinalysis): Occult blood	Number and percentage of subjects will be presented.; Shift tables before and after the dose will be presented.	Up to 8 weeks
Vital signs: Systolic blood pressure (mmHg)	- Summary statistics, scattered plots before and after the dose will be presented.	Up to 8 weeks
Vital signs: Diastolic blood pressure (mmHg)	- Summary statistics, scattered plots before and after the dose will be presented.	Up to 8 weeks
Vital signs: Pulse rate (bpm)	- Summary statistics, scattered plots before and after the dose will be presented.	Up to 8 weeks
Vital signs: Body temperature (°C)	- Summary statistics, scattered plots before and after the dose will be presented.	Up to 8 weeks
Measured values and fluctuations in body weight	- Body weight	Up to 8 weeks
ECG parameter: RR interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
ECG parameter: PR interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
ECG parameter: QRS interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
ECG parameter: QT interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
ECG parameter: QTcF interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
ECG parameter: Pulse rate (bpm)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
KSP-0243 concentration in plasma at each time point	- KSP-0243 concentration in plasma	Up to 8 weeks
KSP-0243 concentration in colorectal mucosa at Week 8	- KSP-0243 concentration in colorectal mucosa	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Kissei Pharmaceutical Co., Ltd.
• Investigators: Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer
• Other Study ID Numbers: 0243CT02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No