An Early Phase 2 Clinical Study of KSP-0243

Kissei Pharmaceutical Co., Ltd.108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Colitis, Ulcerative

Interventions

KSP-0243DRUG

Oral administration

PlaceboDRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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,

Locations (1)

Research Site

Multiple Locations, Japan

Outcomes

Primary Outcomes

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

Time frame: Up to 8 weeks

Secondary Outcomes

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

Time frame: Up to 8 weeks

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

Time frame: Up to 8 weeks

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

Time frame: Up to 8 weeks

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

\- Adverse events, Adverse drug reactions

Time frame: Up to 8 weeks

Data from ClinicalTrials.gov

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