An Early Phase 2 Clinical Study of KSP-0243
- Registration Number
- NCT05831670
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KSP-0243 KSP-0243 Under double-blinding, KSP 0243 tablets will be orally administered. Placebo Placebo Under double-blinding, placebo tablets will be orally administered.
- Primary Outcome Measures
Name Time Method Clinical response rate based on the modified Mayo score at Week 8 Up to 8 weeks 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
- Secondary Outcome Measures
Name Time Method Laboratory test (Blood chemistry): Na (mEq/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Clinical remission rate based on the full Mayo score at Week 8 Up to 8 weeks 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 pointClinical response rate based on the full Mayo score at Week 8 Up to 8 weeks 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 pointECG parameter: Pulse rate (bpm) Up to 8 weeks - Summary statistics will be presented for measured values and changes from baseline.
Laboratory test (Hematology): Neutrophil (10^8/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Hematology): Platelet (10^10/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Hematology): Basophil (10^8/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Cl (mEq/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): γGTP (U/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): BUN (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Clinical remission rate based on the modified Mayo score at Week 8 Up to 8 weeks 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 pointLaboratory test (Hematology): Monocyte (10^8/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Ca (mEq/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): P (mEq/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Total Bilirubin (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Indirect Bilirubin (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Albumin (g/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Uric acid (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): LDH (U/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Incidence of adverse events (AE) and adverse drug reactions (ADR) Up to 8 weeks - Adverse events, Adverse drug reactions
Laboratory tests (Hematology): Hemoglobin (g/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory tests (Hematology): Hematocrit (%) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory tests (Hematology): Erythrocyte (10^10/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Hematology): Lymphocyte (10^8/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): K (mEq/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Total Protein (g/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Creatinine kinase (U/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.KSP-0243 concentration in plasma at each time point Up to 8 weeks - KSP-0243 concentration in plasma
Laboratory test (Hematology): Eosinophil (10^8/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Hematology): Leukocyte (10^6/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Creatinine (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): AST (U/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): ALT (U/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): ALP (U/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Total Cholesterol (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Amylase (U/L) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Blood chemistry): Glucose (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.ECG parameter: RR interval (msec) Up to 8 weeks - Summary statistics will be presented for measured values and changes from baseline.
ECG parameter: QRS interval (msec) Up to 8 weeks - Summary statistics will be presented for measured values and changes from baseline.
Laboratory test (Blood chemistry): Direct Bilirubin (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Urinalysis): Protein Up to 8 weeks * Number and percentage of subjects will be presented.
* Shift tables before and after the dose will be presented.Vital signs: Systolic blood pressure (mmHg) Up to 8 weeks - Summary statistics, scattered plots before and after the dose will be presented.
Vital signs: Pulse rate (bpm) Up to 8 weeks - Summary statistics, scattered plots before and after the dose will be presented.
ECG parameter: QT interval (msec) Up to 8 weeks - Summary statistics will be presented for measured values and changes from baseline.
ECG parameter: QTcF interval (msec) Up to 8 weeks - Summary statistics will be presented for measured values and changes from baseline.
Laboratory test (Blood chemistry): Triglyceride (mg/dL) Up to 8 weeks * Summary statistics, scattered plots before and after the dose will be presented.
* Shift tables before and after dose will be presented.Laboratory test (Urinalysis): Glucose Up to 8 weeks * Number and percentage of subjects will be presented.
* Shift tables before and after the dose will be presented.Laboratory test (Urinalysis): Urobilinogen Up to 8 weeks * Number and percentage of subjects will be presented.
* Shift tables before and after the dose will be presented.Measured values and fluctuations in body weight Up to 8 weeks - Body weight
KSP-0243 concentration in colorectal mucosa at Week 8 Up to 8 weeks - KSP-0243 concentration in colorectal mucosa
Laboratory test (Urinalysis): Occult blood Up to 8 weeks * Number and percentage of subjects will be presented.
* Shift tables before and after the dose will be presented.Vital signs: Diastolic blood pressure (mmHg) Up to 8 weeks - Summary statistics, scattered plots before and after the dose will be presented.
Vital signs: Body temperature (°C) Up to 8 weeks - Summary statistics, scattered plots before and after the dose will be presented.
ECG parameter: PR interval (msec) Up to 8 weeks - Summary statistics will be presented for measured values and changes from baseline.
Trial Locations
- Locations (1)
Research Site
🇯🇵Multiple Locations, Japan