Phase 2
N=121
Dose-response Relationship Study of S42909 on Leg Ulcer Healing
Venous Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03077165 ↗Enrolled (actual)
121
Serious AEs
3.3%
Results posted
Oct 2020
Primary outcome: Primary: Relative Reduction of Reference Ulcer Area After 4 Weeks of Treatment on Top of Standard of Care Compared With Baseline Reference Ulcer Area (W000) Assessed During Study Visits — -52.85; -46.42; -31.07; -43.33 cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- S42909 100 mg (Drug); S42909 200 mg (Drug); S42909 400 mg (Drug); S42909 800 mg (Drug); S42909 1200 mg (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ilkos Therapeutic Inc.
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Reduction of Reference Ulcer Area After 4 Weeks of Treatment on Top of Standard of Care Compared With Baseline Reference Ulcer Area (W000) Assessed During Study Visits |
-52.85; -46.42; -31.07; -43.33; -41.10; -41.23 | — |
| SECONDARY Adverse Events |
— | — |
| SECONDARY Assessment of Laboratory Parameters |
— | — |
Summary
Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.
Eligibility Criteria
Inclusion Criteria
- Caucasian (defined for this study as having 2 Caucasian parents), men or women
- Age ≥ 18 years old
- 18.5 kg/m2 ≤ BMI ≤ 45.0 kg/m2 (= Weight (kg) / height² (m²))
- Patients with chronic venous disease documented by imaging to detect a venous disorder in one or both the sub- and extra-fascial venous systems. The examination performed within 6 months before selection can be used.
- Patients with at least one active venous leg ulcer localised in the gaiter area (CEAP C6) diagnosed or reoccurred for more than 6 weeks and less than 2 years at selection and 3 cm away from other ulcers. Patients with bilateral ulcerations or multiple ulcerations on one or both legs are eligible for selection.
- Size of Reference Ulcer (defined as the largest ulcer in size that is fitting the area selection criteria) should be ≥ 5 cm2 and ≤ 100 cm2 at the selection visit and ≥ 4.5 cm2 and ≤ 100 cm2 at the inclusion visit (measured by transparent sheet and confirmed with the digital 3D imaging device).
- Ankle Brachial Pressure Index (ABPI) ≥ 0.8 and ≤ 1.3 measured by Doppler ultrasound.
Exclusion Criteria
- Unlikely or unwilling to be compliant to standardized compression recommendation, study medication and visits, previous records of poor compliance to compression stockings.
- Inadequately controlled type 1 and type 2 diabetes with an HbA1c > 8%.
Data sourced from ClinicalTrials.gov (NCT03077165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.