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KSP-0243 in Mild to Moderate Active Ulcerative Colitis
NCT05831670Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2023
- Primary completion
- Oct 2024
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- KSP-0243
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 2, randomised, double-blind trial in ulcerative colitis (UC) comparing KSP-0243 with Placebo (2 arms). Primary endpoint: Clinical response rate based on the modified Mayo score at 8 weeks. Started Apr 2023; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
KSP-0243
Oral KSP-0243 once daily + Background 5-ASA
Placebo
Oral Placebo once daily + Background 5-ASA
03
Who it enrols
Patients aged 18-74 with mild to moderate active ulcerative colitis diagnosed for at least 12 weeks, with disease spreading >15 cm from the anal verge, and inadequate response to continued 5-ASA therapy.
04
Endpoints
Primary
Clinical response rate based on the modified Mayo score
Secondary
Clinical remission rate based on the modified Mayo score
Clinical response rate based on the full Mayo score
Clinical remission rate based on the full Mayo score
Incidence of adverse events (AE) and adverse drug reactions (ADR)
Hemoglobin
Hematocrit
KSP-0243 concentration in plasma
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