An Early Phase 2 Clinical Study of KSP-0243

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 74 Years
Gender All
More Inclusion & Exclusion 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,

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kissei Pharmaceutical Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yoshitaka Shimizu
Principal Investigator Affiliation Kissei Pharmaceutical Co., Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Japan

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Arms & Interventions


Experimental: KSP-0243

Under double-blinding, KSP 0243 tablets will be orally administered.

Placebo Comparator: Placebo

Under double-blinding, placebo tablets will be orally administered.


Drug: - KSP-0243

Oral administration

Drug: - Placebo

Oral administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Research Site, Multiple Locations, Japan




Research Site

Multiple Locations, ,