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Completed

NCT Number: NCT05831670

An Early Phase 2 Clinical Study of KSP-0243

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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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

KSP-0243

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Clinical response rate based on the modified Mayo score at Week 8

    Time frame: 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 outcomes

  1. Clinical remission rate based on the modified Mayo score at Week 8

    Time frame: 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

  2. Clinical response rate based on the full Mayo score at Week 8

    Time frame: 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

  3. Clinical remission rate based on the full Mayo score at Week 8

    Time frame: 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

  4. Incidence of adverse events (AE) and adverse drug reactions (ADR)

    Time frame: Up to 8 weeks

    • Adverse events, Adverse drug reactions

  5. Laboratory tests (Hematology): Hemoglobin (g/dL)

    Time frame: 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.

  6. Laboratory tests (Hematology): Hematocrit (%)

    Time frame: 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.

  7. Laboratory tests (Hematology): Erythrocyte (10^10/L)

    Time frame: 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.

  8. Laboratory test (Hematology): Leukocyte (10^6/L)

    Time frame: 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.

  9. Laboratory test (Hematology): Neutrophil (10^8/L)

    Time frame: 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.

  10. Laboratory test (Hematology): Eosinophil (10^8/L)

    Time frame: 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.

  11. Laboratory test (Hematology): Basophil (10^8/L)

    Time frame: 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.

  12. Laboratory test (Hematology): Monocyte (10^8/L)

    Time frame: 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.

  13. Laboratory test (Hematology): Lymphocyte (10^8/L)

    Time frame: 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.

  14. Laboratory test (Hematology): Platelet (10^10/L)

    Time frame: 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.

  15. Laboratory test (Blood chemistry): Na (mEq/L)

    Time frame: 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.

  16. Laboratory test (Blood chemistry): K (mEq/L)

    Time frame: 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.

  17. Laboratory test (Blood chemistry): Cl (mEq/L)

    Time frame: 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.

  18. Laboratory test (Blood chemistry): Ca (mEq/L)

    Time frame: 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.

  19. Laboratory test (Blood chemistry): P (mEq/L)

    Time frame: 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.

  20. Laboratory test (Blood chemistry): Creatinine (mg/dL)

    Time frame: 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.

  21. Laboratory test (Blood chemistry): Total Bilirubin (mg/dL)

    Time frame: 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.

  22. Laboratory test (Blood chemistry): Direct Bilirubin (mg/dL)

    Time frame: 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.

  23. Laboratory test (Blood chemistry): Indirect Bilirubin (mg/dL)

    Time frame: 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.

  24. Laboratory test (Blood chemistry): Total Protein (g/dL)

    Time frame: 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.

  25. Laboratory test (Blood chemistry): Albumin (g/dL)

    Time frame: 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.

  26. Laboratory test (Blood chemistry): AST (U/L)

    Time frame: 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.

  27. Laboratory test (Blood chemistry): ALT (U/L)

    Time frame: 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.

  28. Laboratory test (Blood chemistry): γGTP (U/L)

    Time frame: 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.

  29. Laboratory test (Blood chemistry): ALP (U/L)

    Time frame: 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.

  30. Laboratory test (Blood chemistry): Creatinine kinase (U/L)

    Time frame: 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.

  31. Laboratory test (Blood chemistry): Uric acid (mg/dL)

    Time frame: 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.

  32. Laboratory test (Blood chemistry): BUN (mg/dL)

    Time frame: 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.

  33. Laboratory test (Blood chemistry): LDH (U/L)

    Time frame: 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.

  34. Laboratory test (Blood chemistry): Total Cholesterol (mg/dL)

    Time frame: 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.

  35. Laboratory test (Blood chemistry): Triglyceride (mg/dL)

    Time frame: 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.

  36. Laboratory test (Blood chemistry): Amylase (U/L)

    Time frame: 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.

  37. Laboratory test (Blood chemistry): Glucose (mg/dL)

    Time frame: 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.

  38. Laboratory test (Urinalysis): Protein

    Time frame: Up to 8 weeks

    • Number and percentage of subjects will be presented.
    • Shift tables before and after the dose will be presented.

  39. Laboratory test (Urinalysis): Glucose

    Time frame: Up to 8 weeks

    • Number and percentage of subjects will be presented.
    • Shift tables before and after the dose will be presented.

  40. Laboratory test (Urinalysis): Urobilinogen

    Time frame: Up to 8 weeks

    • Number and percentage of subjects will be presented.
    • Shift tables before and after the dose will be presented.

  41. Laboratory test (Urinalysis): Occult blood

    Time frame: Up to 8 weeks

    • Number and percentage of subjects will be presented.
    • Shift tables before and after the dose will be presented.

  42. Vital signs: Systolic blood pressure (mmHg)

    Time frame: Up to 8 weeks

    • Summary statistics, scattered plots before and after the dose will be presented.

  43. Vital signs: Diastolic blood pressure (mmHg)

    Time frame: Up to 8 weeks

    • Summary statistics, scattered plots before and after the dose will be presented.

  44. Vital signs: Pulse rate (bpm)

    Time frame: Up to 8 weeks

    • Summary statistics, scattered plots before and after the dose will be presented.

  45. Vital signs: Body temperature (°C)

    Time frame: Up to 8 weeks

    • Summary statistics, scattered plots before and after the dose will be presented.

  46. Measured values and fluctuations in body weight

    Time frame: Up to 8 weeks

    • Body weight

  47. ECG parameter: RR interval (msec)

    Time frame: Up to 8 weeks

    • Summary statistics will be presented for measured values and changes from baseline.

  48. ECG parameter: PR interval (msec)

    Time frame: Up to 8 weeks

    • Summary statistics will be presented for measured values and changes from baseline.

  49. ECG parameter: QRS interval (msec)

    Time frame: Up to 8 weeks

    • Summary statistics will be presented for measured values and changes from baseline.

  50. ECG parameter: QT interval (msec)

    Time frame: Up to 8 weeks

    • Summary statistics will be presented for measured values and changes from baseline.

  51. ECG parameter: QTcF interval (msec)

    Time frame: Up to 8 weeks

    • Summary statistics will be presented for measured values and changes from baseline.

  52. ECG parameter: Pulse rate (bpm)

    Time frame: Up to 8 weeks

    • Summary statistics will be presented for measured values and changes from baseline.

  53. KSP-0243 concentration in plasma at each time point

    Time frame: Up to 8 weeks

    • KSP-0243 concentration in plasma

  54. KSP-0243 concentration in colorectal mucosa at Week 8

    Time frame: Up to 8 weeks

    • KSP-0243 concentration in colorectal mucosa

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Early Phase 2 Clinical Study of KSP-0243 in Patients With Mild to Moderate Active Ulcerative Colitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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