An Early Phase 2 Clinical Study of KSP-0243

Colitis, Ulcerative Clinical Trial

Official title:

An Early Phase 2 Clinical Study of KSP-0243 in Patients With Mild to Moderate Active Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831670
• Other study ID #: 0243CT02
• Status: Recruiting
• Phase: Phase 2
• Start date: April 27, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: Yoshitaka Shimizu
• Phone: E-mail only
• Email: rinsyousiken[@]pharm.kissei.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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,

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• KSP-0243
Oral administration
• Placebo
Oral administration

Locations

Country	Name	City	State
Japan	Research Site	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Incidence of adverse events (AE) and adverse drug reactions (ADR)	- Adverse events, Adverse drug reactions	Up to 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Laboratory test (Blood chemistry): ?GTP (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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Vital signs: Systolic blood pressure (mmHg)	- Summary statistics, scattered plots before and after the dose will be presented.	Up to 8 weeks
Secondary	Vital signs: Diastolic blood pressure (mmHg)	- Summary statistics, scattered plots before and after the dose will be presented.	Up to 8 weeks
Secondary	Vital signs: Pulse rate (bpm)	- Summary statistics, scattered plots before and after the dose will be presented.	Up to 8 weeks
Secondary	Vital signs: Body temperature (°C)	- Summary statistics, scattered plots before and after the dose will be presented.	Up to 8 weeks
Secondary	Measured values and fluctuations in body weight	- Body weight	Up to 8 weeks
Secondary	ECG parameter: RR interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
Secondary	ECG parameter: PR interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
Secondary	ECG parameter: QRS interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
Secondary	ECG parameter: QT interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
Secondary	ECG parameter: QTcF interval (msec)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
Secondary	ECG parameter: Pulse rate (bpm)	- Summary statistics will be presented for measured values and changes from baseline.	Up to 8 weeks
Secondary	KSP-0243 concentration in plasma at each time point	- KSP-0243 concentration in plasma	Up to 8 weeks
Secondary	KSP-0243 concentration in colorectal mucosa at Week 8	- KSP-0243 concentration in colorectal mucosa	Up to 8 weeks