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S42909 dose-response for venous leg ulcer healing
NCT03077165Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2017
- Primary completion
- Dec 2019
- Countries
- 11
- Sponsor
- Ilkos Therapeutics
- Modality
- Small Molecules
- Drugs
- ilkodostat
- Conditions
- venous leg ulcer (VLU)
01
Overview
Phase 2, randomised, double-blind trial of ilkodostat in venous leg ulcer (VLU) (6 arms), sponsored by Ilkos Therapeutics. Primary endpoint: Relative Reduction of Reference Ulcer Area at 4 weeks. Started Sep 2017; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
S42909 100 mg
S42909 100 mg/day
S42909 200 mg
S42909 200 mg/day
S42909 400 mg
S42909 400 mg/day
S42909 800 mg
S42909 800 mg/day
S42909 1200 mg
S42909 1200 mg/day
Placebo
Placebo
03
Who it enrols
Patients with chronic venous disease and at least one active venous leg ulcer (5-100 cm2) present for >6 weeks and <2 years.
04
Endpoints
Primary
Relative Reduction of Reference Ulcer Area
Secondary
Adverse Events
Assessment of Laboratory Parameters
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