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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSP-0243 | Experimental | Under double-blinding, KSP 0243 tablets will be orally administered. |
|
| Placebo | Placebo Comparator | Under double-blinding, placebo tablets will be orally administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSP-0243 | Drug | Oral administration |
| |
| Placebo |
| 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:
| Up to 8 weeks |
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshitaka Shimizu | Kissei Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Multiple Locations | Japan |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
Oral administration |
|
| 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.
| 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.
| 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) |
| Up to 8 weeks |
| Laboratory tests (Hematology): Hematocrit (%) |
| Up to 8 weeks |
| Laboratory tests (Hematology): Erythrocyte (10^10/L) |
| Up to 8 weeks |
| Laboratory test (Hematology): Leukocyte (10^6/L) |
| Up to 8 weeks |
| Laboratory test (Hematology): Neutrophil (10^8/L) |
| Up to 8 weeks |
| Laboratory test (Hematology): Eosinophil (10^8/L) |
| Up to 8 weeks |
| Laboratory test (Hematology): Basophil (10^8/L) |
| Up to 8 weeks |
| Laboratory test (Hematology): Monocyte (10^8/L) |
| Up to 8 weeks |
| Laboratory test (Hematology): Lymphocyte (10^8/L) |
| Up to 8 weeks |
| Laboratory test (Hematology): Platelet (10^10/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Na (mEq/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): K (mEq/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Cl (mEq/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Ca (mEq/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): P (mEq/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Creatinine (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Total Bilirubin (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Direct Bilirubin (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Indirect Bilirubin (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Total Protein (g/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Albumin (g/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): AST (U/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): ALT (U/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): γGTP (U/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): ALP (U/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Creatinine kinase (U/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Uric acid (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): BUN (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): LDH (U/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Total Cholesterol (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Triglyceride (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Amylase (U/L) |
| Up to 8 weeks |
| Laboratory test (Blood chemistry): Glucose (mg/dL) |
| Up to 8 weeks |
| Laboratory test (Urinalysis): Protein |
| Up to 8 weeks |
| Laboratory test (Urinalysis): Glucose |
| Up to 8 weeks |
| Laboratory test (Urinalysis): Urobilinogen |
| Up to 8 weeks |
| Laboratory test (Urinalysis): Occult blood |
| 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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |