An Early Phase 2 Clinical Study of KSP-0243

NCT05831670 | Completed Phase 2

• 1 other identifier: 0243CT02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 8 weeks

Secondary Outcomes (54)

• Clinical remission rate based on the modified Mayo score at Week 8

  Up to 8 weeks

• Clinical response rate based on the full Mayo score at Week 8

  Up to 8 weeks

• Clinical remission rate based on the full Mayo score at Week 8

  Up to 8 weeks

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

  Up to 8 weeks

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

  Up to 8 weeks

Study Arms (2)

KSP-0243

EXPERIMENTAL

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

Drug: KSP-0243

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KSP-0243 DRUG

Oral administration

KSP-0243

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Kissei Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Research Site

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Yoshitaka Shimizu

  Kissei Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 26, 2023
• Study Start: April 27, 2023
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)