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Colitis, UlcerativePhase 2NCT05831670

An Early Phase 2 Clinical Study of KSP-0243

A Phase 2 study testing KSP-0243 in people with Colitis, Ulcerative, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
KSP-0243
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
1 siteJapan
Study dates
27 Apr 2023to 18 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Research Site

    Multiple Locations

Other trials in Japan

About this study

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

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.

Being tested
KSP-0243, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KSP-0243Drug

    Oral administration

  • PlaceboDrug

    Oral administration

Study groups in NCT05831670
Study groupRoleWhat they receive
KSP-0243ExperimentalUnder double-blinding, KSP 0243 tablets will be orally administered.
Receives: Drug: KSP-0243
PlaceboPlacebo comparatorUnder double-blinding, placebo tablets will be orally administered.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: Up to 8 weeks

Secondary outcomes (54)

  1. 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:

    • 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

    Measured: Up to 8 weeks

  2. 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.

    • 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

    Measured: Up to 8 weeks

  3. 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.

    • Full Mayo score is ≤ 2 points
    • All the subscores are ≤ 1 point

    Measured: Up to 8 weeks

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

    • Adverse events, Adverse drug reactions

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

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

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

    Measured: Up to 8 weeks

  38. Laboratory test (Urinalysis): Protein

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

    Measured: Up to 8 weeks

  39. Laboratory test (Urinalysis): Glucose

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

    Measured: Up to 8 weeks

  40. Laboratory test (Urinalysis): Urobilinogen

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

    Measured: Up to 8 weeks

  41. Laboratory test (Urinalysis): Occult blood

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

    Measured: Up to 8 weeks

  42. Vital signs: Systolic blood pressure (mmHg)

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

    Measured: Up to 8 weeks

  43. Vital signs: Diastolic blood pressure (mmHg)

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

    Measured: Up to 8 weeks

  44. Vital signs: Pulse rate (bpm)

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

    Measured: Up to 8 weeks

  45. Vital signs: Body temperature (°C)

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

    Measured: Up to 8 weeks

  46. Measured values and fluctuations in body weight

    • Body weight

    Measured: Up to 8 weeks

  47. ECG parameter: RR interval (msec)

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

    Measured: Up to 8 weeks

  48. ECG parameter: PR interval (msec)

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

    Measured: Up to 8 weeks

  49. ECG parameter: QRS interval (msec)

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

    Measured: Up to 8 weeks

  50. ECG parameter: QT interval (msec)

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

    Measured: Up to 8 weeks

  51. ECG parameter: QTcF interval (msec)

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

    Measured: Up to 8 weeks

  52. ECG parameter: Pulse rate (bpm)

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

    Measured: Up to 8 weeks

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

    • KSP-0243 concentration in plasma

    Measured: Up to 8 weeks

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

    • KSP-0243 concentration in colorectal mucosa

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start27 Apr 2023
  3. Primary completion18 Oct 2024
  4. Study completion18 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831670
Sponsor's protocol ID
0243CT02
Status last verified
Mar 2025
First submitted
2 Mar 2023
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KSP-0243 in people with Colitis, Ulcerative, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response rate based on the modified Mayo score at Week 8 (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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