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An Early Phase 2 Clinical Study of KSP-0243

NCT05831670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-03-17

No results posted yet for this study

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

Interventions

DRUG

KSP-0243

Oral administration

DRUG

Placebo

Oral administration

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoshitaka Shimizu · Kissei Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2024-10-18
Completion
2024-10-18

Countries

  • Japan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831670 on ClinicalTrials.gov