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Dose-response Relationship Study of S42909 on Leg Ulcer Healing
Phase 2 trial testing S42909 100 mg in Venous Leg Ulcer in 121 participants. Completed in 22 January 2020.
| Lead sponsor | Ilkos Therapeutic Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 121 |
| Start date | 12 September 2017 |
| Primary completion | 12 December 2019 |
| Estimated completion | 22 January 2020 |
| Sites | 80 locations across Italy, Slovakia, Austria, Hungary, Poland, Argentina, Canada, Spain |
Ilkos Therapeutic Inc. — full company profile →
18 and older, any sex, with Venous Leg Ulcer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change of reference Ulcer area measurement in cm\^2 from Baseline to Week 4.
| Group | Value | 95% CI |
|---|---|---|
| Group A | -52.85 | ± 37.79 |
| Group B | -46.42 | ± 33.30 |
| Group C | -31.07 | ± 38.73 |
| Group D | -43.33 | ± 28.37 |
| Group E | -41.10 | ± 33.99 |
| Group F | -41.23 | ± 43.71 |
Time frame: Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.. Reporting threshold: 4.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group A | Group B | Group C | Group D | Group E | Group F |
|---|---|---|---|---|---|---|---|
| Hypertension | Vascular disorders | — | — | — | — | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — | — | — | — | — |
| Cardiac Failure | Cardiac disorders | — | — | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — | — |
| Reaction | System | Group A | Group B | Group C | Group D | Group E | Group F |
|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Eczema | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Skin ulcer | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Infected skin ulcer | Infections and infestations | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — |
| Pallor | Vascular disorders | — | — | — | — | — | — |
| Colon Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — | — |
| Peripheral oedema | General disorders | — | — | — | — | — | — |
| Uterine polyp | Reproductive system and breast disorders | — | — | — | — | — | — |
| Accidental overdose | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Incorrect product administration duration | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Overdose | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Skin laceration | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — | — | — |
| Blood glucose increased | Investigations | — | — | — | — | — | — |
| C-reactine protein increased | Investigations | — | — | — | — | — | — |
| Gamma-glutamyltrnasferase increased | Investigations | — | — | — | — | — | — |
| International normalised ratio decreased | Investigations | — | — | — | — | — | — |
| Atrioventricular block first degree | Cardiac disorders | — | — | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Increased bronchial secretions | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Iron deficiency anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — |
| somnolence | Nervous system disorders | — | — | — | — | — | — |
| Tinnitus | Ear and labyrinth disorders | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Food poisoning | Gastrointestinal disorders | — | — | — | — | — | — |
| Pseudopolyposis | Gastrointestinal disorders | — | — | — | — | — | — |
| Toothache | Gastrointestinal disorders | — | — | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — | — | — |
| Ureterolithiasis | Renal and urinary disorders | — | — | — | — | — | — |
| Blister | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
Most-reported serious reactions: Hypertension, Atrial Fibrillation, Cardiac Failure, Neutropenia, Arthritis, Pneumonia.
Data from ClinicalTrials.gov NCT03077165 adverse events section.
Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03077165.
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