An Early Phase 2 Clinical Study of KSP-0243

Kissei

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Placebo; Drug: KSP-0243

Study type: Interventional

Funder types: Industry

Identifiers

NCT05831670

0243CT02

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

KSP-0243

Experimental group

Description:

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

Treatment:

Drug: KSP-0243

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo