Clinical trial NCT05831670: An Early Phase 2 Clinical Study of KSP-0243
Official title: An Early Phase 2 Clinical Study of KSP-0243 in Patients With Mild to Moderate Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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,

Primary outcomes:
measure: Clinical response rate based on the modified Mayo score at Week 8
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Clinical remission rate based on the modified Mayo score at Week 8
timeFrame: Up to 8 weeks
measure: Clinical response rate based on the full Mayo score at Week 8
timeFrame: Up to 8 weeks
measure: Clinical remission rate based on the full Mayo score at Week 8
timeFrame: Up to 8 weeks
measure: Incidence of adverse events (AE) and adverse drug reactions (ADR)
timeFrame: Up to 8 weeks
measure: Laboratory tests (Hematology): Hemoglobin (g/dL)
timeFrame: Up to 8 weeks
measure: Laboratory tests (Hematology): Hematocrit (%)
timeFrame: Up to 8 weeks
measure: Laboratory tests (Hematology): Erythrocyte (10^10/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Hematology): Leukocyte (10^6/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Hematology): Neutrophil (10^8/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Hematology): Eosinophil (10^8/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Hematology): Basophil (10^8/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Hematology): Monocyte (10^8/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Hematology): Lymphocyte (10^8/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Hematology): Platelet (10^10/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Na (mEq/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): K (mEq/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Cl (mEq/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Ca (mEq/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): P (mEq/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Creatinine (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Total Bilirubin (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Direct Bilirubin (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Indirect Bilirubin (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Total Protein (g/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Albumin (g/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): AST (U/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): ALT (U/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): γGTP (U/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): ALP (U/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Creatinine kinase (U/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Uric acid (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): BUN (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): LDH (U/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Total Cholesterol (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Triglyceride (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Amylase (U/L)
timeFrame: Up to 8 weeks
measure: Laboratory test (Blood chemistry): Glucose (mg/dL)
timeFrame: Up to 8 weeks
measure: Laboratory test (Urinalysis): Protein
timeFrame: Up to 8 weeks
measure: Laboratory test (Urinalysis): Glucose
timeFrame: Up to 8 weeks
measure: Laboratory test (Urinalysis): Urobilinogen
timeFrame: Up to 8 weeks
measure: Laboratory test (Urinalysis): Occult blood
timeFrame: Up to 8 weeks
measure: Vital signs: Systolic blood pressure (mmHg)
timeFrame: Up to 8 weeks
measure: Vital signs: Diastolic blood pressure (mmHg)
timeFrame: Up to 8 weeks
measure: Vital signs: Pulse rate (bpm)
timeFrame: Up to 8 weeks
measure: Vital signs: Body temperature (°C)
timeFrame: Up to 8 weeks
measure: Measured values and fluctuations in body weight
timeFrame: Up to 8 weeks
measure: ECG parameter: RR interval (msec)
timeFrame: Up to 8 weeks
measure: ECG parameter: PR interval (msec)
timeFrame: Up to 8 weeks
measure: ECG parameter: QRS interval (msec)
timeFrame: Up to 8 weeks
measure: ECG parameter: QT interval (msec)
timeFrame: Up to 8 weeks
measure: ECG parameter: QTcF interval (msec)
timeFrame: Up to 8 weeks
measure: ECG parameter: Pulse rate (bpm)
timeFrame: Up to 8 weeks
measure: KSP-0243 concentration in plasma at each time point
timeFrame: Up to 8 weeks
measure: KSP-0243 concentration in colorectal mucosa at Week 8
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yoshitaka Shimizu
role: STUDY_DIRECTOR
References: