Colitis, Ulcerative
Conditions
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.
Interventions
DRUGKSP-0243
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 point |
| Clinical 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 point |
| 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. |
| 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. |
| 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 point |
| 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): 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 (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): 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): 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 (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 (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 (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 (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. |
| 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): 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): 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): 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): 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): 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): 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 (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): 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): 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): 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. |
| 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. |
| 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): 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 (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. |
| 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. |
| 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. |
| 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: Systolic blood pressure (mmHg) | Up to 8 weeks | \- Summary statistics, scattered plots 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: Pulse rate (bpm) | 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. |
| Measured values and fluctuations in body weight | Up to 8 weeks | \- Body weight |
| ECG parameter: RR interval (msec) | Up to 8 weeks | \- Summary statistics will be presented for measured values and changes from baseline. |
| ECG parameter: PR interval (msec) | Up to 8 weeks | \- Summary statistics will be presented for measured values and changes from baseline. |
| 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. |
| 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. |
| ECG parameter: Pulse rate (bpm) | Up to 8 weeks | \- Summary statistics will be presented for measured values and changes from baseline. |
| KSP-0243 concentration in plasma at each time point | Up to 8 weeks | \- KSP-0243 concentration in plasma |
| KSP-0243 concentration in colorectal mucosa at Week 8 | Up to 8 weeks | \- KSP-0243 concentration in colorectal mucosa |
| ECG parameter: QRS interval (msec) | Up to 8 weeks | \- Summary statistics will be presented for measured values and changes from baseline. |
Countries
Japan
Outcome results
None listed