Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.

Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer. A 10-week randomized, double-blind, placebo-controlled, prospective, international, multicentre, phase IIa study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004143-36-AT

Enrollment

204

Registered

2017-04-24

Start date

2017-05-30

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous leg ulcer MedDRA version: 20.0 Level: LLT Classification code 10068310 Term: Leg ulcer System Organ Class: 100000004858

Interventions

Product Name: S42909 Product Code: S42909 Pharmaceutical Form: Film-coated tablet Current Sponsor code: S42909 Other descriptive name: S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Caucasian, 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 the sub- and extra-fascial venous system. 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 (measured by transparent sheet and confirmed with the digital 3D imaging device). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 102 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 102

Exclusion criteria

Exclusion criteria: - Unlikely or unwilling to be compliant to standardized compression recommendation, study medication and visits, previous records of poor compliance to compression stockings.

Design outcomes

Primary

Measure	Time frame
Main Objective: To detect the existence of an overall dose-response relationship with S42909 on improving healing of venous leg ulcers on top of standard of care (compression and local wound care) after 4 weeks of treatment.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Week 4.; Secondary Objective: - To assess the safety profile of each tested dose of S42909 (adverse events, laboratory parameters, physical examination, body weight, vital signs (blood pressure, heart rate), 6 or 12-lead electrocardiogram (ECG). and standard urinalysis). - To assess pharmacokinetics of S42909 and its metabolites in patients after repeated administration of S-42909.	—

Measure

Time frame

Main Objective: To detect the existence of an overall dose-response relationship with S42909 on improving healing of venous leg ulcers on top of standard of care (compression and local wound care) after 4 weeks of treatment.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Week 4.; Secondary Objective: - To assess the safety profile of each tested dose of S42909 (adverse events, laboratory parameters, physical examination, body weight, vital signs (blood pressure, heart rate), 6 or 12-lead electrocardiogram (ECG). and standard urinalysis). - To assess pharmacokinetics of S42909 and its metabolites in patients after repeated administration of S-42909.

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Secondary

Measure	Time frame
Secondary end point(s): - Safety measurements. - Assessment of laboratory parameters: Biochemistry, Haematology and Fasting Lipids. ; Timepoint(s) of evaluation of this end point: - Safety measurements. - Physical examination (ASSE, W000, W001, W002, W003, W004, W006, W008). - 6 or 12-leads electrocardiogram (ASSE, W000, W001, W002, W003, W004, W006, W008). - Laboratory assessments (ASSE, W000, W001, W002, W004, W006, W008). - Adverse events (from ASSE to W008). - Laboratory parameters: ASSE, W000, W001, W002, W004, W006, W008.	—

Measure

Time frame

Secondary end point(s): - Safety measurements. - Assessment of laboratory parameters: Biochemistry, Haematology and Fasting Lipids. ; Timepoint(s) of evaluation of this end point: - Safety measurements. - Physical examination (ASSE, W000, W001, W002, W003, W004, W006, W008). - 6 or 12-leads electrocardiogram (ASSE, W000, W001, W002, W003, W004, W006, W008). - Laboratory assessments (ASSE, W000, W001, W002, W004, W006, W008). - Adverse events (from ASSE to W008). - Laboratory parameters: ASSE, W000, W001, W002, W004, W006, W008.

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Countries

Austria, Canada, Czech Republic, Denmark, Germany, Italy, Slovakia, Spain, United States

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155724366

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026