An Early Phase 2 Clinical Study of KSP-0243

March 12, 2025 updated by: Kissei Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Multiple Locations, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: KSP-0243
Under double-blinding, KSP 0243 tablets will be orally administered.
Drug: KSP-0243
Oral administration
Placebo Comparator: Placebo
Under double-blinding, placebo tablets will be orally administered.
Drug: Placebo
Oral administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Up to 8 weeks
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
Up to 8 weeks
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
Up to 8 weeks
Incidence of adverse events (AE) and adverse drug reactions (ADR)
Time Frame: Up to 8 weeks
- Adverse events, Adverse drug reactions
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks
Vital signs: Systolic blood pressure (mmHg)
Time Frame: Up to 8 weeks
- Summary statistics, scattered plots before and after the dose will be presented.
Up to 8 weeks
Vital signs: Diastolic blood pressure (mmHg)
Time Frame: Up to 8 weeks
- Summary statistics, scattered plots before and after the dose will be presented.
Up to 8 weeks
Vital signs: Pulse rate (bpm)
Time Frame: Up to 8 weeks
- Summary statistics, scattered plots before and after the dose will be presented.
Up to 8 weeks
Vital signs: Body temperature (°C)
Time Frame: Up to 8 weeks
- Summary statistics, scattered plots before and after the dose will be presented.
Up to 8 weeks
Measured values and fluctuations in body weight
Time Frame: Up to 8 weeks
- Body weight
Up to 8 weeks
ECG parameter: RR interval (msec)
Time Frame: Up to 8 weeks
- Summary statistics will be presented for measured values and changes from baseline.
Up to 8 weeks
ECG parameter: PR interval (msec)
Time Frame: Up to 8 weeks
- Summary statistics will be presented for measured values and changes from baseline.
Up to 8 weeks
ECG parameter: QRS interval (msec)
Time Frame: Up to 8 weeks
- Summary statistics will be presented for measured values and changes from baseline.
Up to 8 weeks
ECG parameter: QT interval (msec)
Time Frame: Up to 8 weeks
- Summary statistics will be presented for measured values and changes from baseline.
Up to 8 weeks
ECG parameter: QTcF interval (msec)
Time Frame: Up to 8 weeks
- Summary statistics will be presented for measured values and changes from baseline.
Up to 8 weeks
ECG parameter: Pulse rate (bpm)
Time Frame: Up to 8 weeks
- 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
Time Frame: Up to 8 weeks
- KSP-0243 concentration in plasma
Up to 8 weeks
KSP-0243 concentration in colorectal mucosa at Week 8
Time Frame: Up to 8 weeks
- KSP-0243 concentration in colorectal mucosa
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kissei Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0243CT02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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