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	No
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.	Interventional
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 ClinicalTrials.gov, 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.	NCT05831670
Phase 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.	Industry
Overall Status	Recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Colitis, Ulcerative

Arms & Interventions

Arms

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.

Interventions

Drug: - KSP-0243

Oral administration

Drug: - Placebo

Oral administration

Contact a Trial Team

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International Sites

Research Site, Multiple Locations, Japan

Status

Recruiting

Address

Research Site

Multiple Locations, ,

Site Contact

rinsyousiken@pharm.kissei.co.jp

E-mail only

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