NCT05831670已完成2 期
An Early Phase 2 Clinical Study of KSP-0243 in Patients With Mild to Moderate Active Ulcerative Colitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Clinical response rate based on the modified Mayo score at Week 8
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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,
研究组 & 干预措施
KSP-0243
Experimental
Under double-blinding, KSP 0243 tablets will be orally administered.
干预措施: KSP-0243 (Drug)
Placebo
Placebo Comparator
Under double-blinding, placebo tablets will be orally administered.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical response rate based on the modified Mayo score at Week 8
时间窗: 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
次要结局
- Laboratory test (Blood chemistry): Na (mEq/L)(Up to 8 weeks)
- Clinical remission rate based on the full Mayo score at Week 8(Up to 8 weeks)
- Clinical response rate based on the full Mayo score at Week 8(Up to 8 weeks)
- Laboratory test (Hematology): Neutrophil (10^8/L)(Up to 8 weeks)
- Laboratory test (Hematology): Platelet (10^10/L)(Up to 8 weeks)
- Laboratory test (Hematology): Basophil (10^8/L)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Cl (mEq/L)(Up to 8 weeks)
- Laboratory test (Blood chemistry): γGTP (U/L)(Up to 8 weeks)
- Laboratory test (Blood chemistry): BUN (mg/dL)(Up to 8 weeks)
- Clinical remission rate based on the modified Mayo score at Week 8(Up to 8 weeks)
- Laboratory test (Hematology): Monocyte (10^8/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): Total Bilirubin (mg/dL)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Indirect Bilirubin (mg/dL)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Albumin (g/dL)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Uric acid (mg/dL)(Up to 8 weeks)
- Laboratory test (Blood chemistry): LDH (U/L)(Up to 8 weeks)
- Incidence of adverse events (AE) and adverse drug reactions (ADR)(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): Lymphocyte (10^8/L)(Up to 8 weeks)
- Laboratory test (Blood chemistry): K (mEq/L)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Total Protein (g/dL)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Creatinine kinase (U/L)(Up to 8 weeks)
- KSP-0243 concentration in plasma at each time point(Up to 8 weeks)
- Laboratory test (Hematology): Leukocyte (10^6/L)(Up to 8 weeks)
- Laboratory test (Hematology): Eosinophil (10^8/L)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Creatinine (mg/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): ALP (U/L)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Total Cholesterol (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)
- ECG parameter: RR interval (msec)(Up to 8 weeks)
- ECG parameter: QRS interval (msec)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Direct Bilirubin (mg/dL)(Up to 8 weeks)
- Laboratory test (Urinalysis): Protein(Up to 8 weeks)
- Vital signs: Systolic blood pressure (mmHg)(Up to 8 weeks)
- Vital signs: Pulse rate (bpm)(Up to 8 weeks)
- ECG parameter: QT interval (msec)(Up to 8 weeks)
- ECG parameter: QTcF interval (msec)(Up to 8 weeks)
- ECG parameter: Pulse rate (bpm)(Up to 8 weeks)
- Laboratory test (Blood chemistry): Triglyceride (mg/dL)(Up to 8 weeks)
- Laboratory test (Urinalysis): Glucose(Up to 8 weeks)
- Laboratory test (Urinalysis): Urobilinogen(Up to 8 weeks)
- Measured values and fluctuations in body weight(Up to 8 weeks)
- KSP-0243 concentration in colorectal mucosa at Week 8(Up to 8 weeks)
- Laboratory test (Urinalysis): Occult blood(Up to 8 weeks)
- Vital signs: Diastolic blood pressure (mmHg)(Up to 8 weeks)
- Vital signs: Body temperature (°C)(Up to 8 weeks)
- ECG parameter: PR interval (msec)(Up to 8 weeks)
研究者
研究点 (1)
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