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CYWC628 · 1 trial · 1 indication
Evaluate the safety and tolerability of Standard of Care (SoC) + CYWC628 in patients with diabetic foot ulcer (DFU) as compared to SoC only. • Adverse events, including severity grading using Common Terminology Criteria for Adverse Events (CTCAE v5.0), and relationship to treatment.
Evaluate the efficacy of SoC + low dose and high dose CYWC628 in wound healing of DFU, compared with SoC only. Proportion of participants with complete wound closure by 12 weeks after commencing study treatment or SoC. Complete wound closure is defined as 100% re-epithelialization with no wound drainage, as determined by the Investigator, observed at 2 visits 2 weeks apart
Evaluate the safety and tolerability of Standard of Care (SoC) + CYWC628 in patients with diabetic foot ulcer (DFU) as compared to SoC only. Percentage area reduction (PAR) of the DFU wound during the 12 week treatment period.
| Arm | Type | Description |
|---|---|---|
| Standard of Care | ACTIVE_COMPARATOR | Standard of care used for the treatment of diabetic foot ulcers once weekly for up to 12 weeks. |
| SoC + Low dose CYWC628 | EXPERIMENTAL | standard of care (SoC) + low dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks: |
| SoC + High dose CYWC628 | EXPERIMENTAL | standard of care + high dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks: |
| Name | Type | Description |
|---|---|---|
| Standard of Care (SOC) | OTHER | The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. |
| SoC + Low dose CYWC628 | BIOLOGICAL | The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. Low dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks |
| SoC + High dose CYWC628 | BIOLOGICAL | The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. High dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks |
Inclusion Criteria: 1. Males or females aged 18 to 80 years inclusive at time of informed consent. 2. Diagnosed/confirmed Type 1 or 2 diabetes mellitus. 3. Presence of diabetic foot ulcer (DFU) at or below the level of the malleolus that is confined to one anatomical site and without exposure of bo...
CYWC628 is an investigational therapy being developed by FibroBiologics, Inc. for diabetic foot ulcer (DFU), a metabolic wound-healing condition. It is a monoclonal antibody modality and is currently in Phase 1 clinical development. It is not approved for any indication and remains under study in a controlled clinical trial.
CYWC628 is being studied for the treatment of refractory diabetic foot ulcers, meaning DFUs that have not responded to prior care. The Phase 1 trial evaluates CYWC628 given alongside standard of care compared with standard of care alone in adults with this condition.
CYWC628 is developed by FibroBiologics, Inc., which trades under the ticker FBLG. The company is the sponsor of the clinical program evaluating the asset in diabetic foot ulcer. No other developer or partner is associated with CYWC628 in the available program information.
CYWC628 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulator. The program currently has one active trial, which is recruiting participants, and no completed trials to date.
CYWC628 is being studied in trial NCT07096934, titled a controlled trial to evaluate the safety and efficacy of CYWC628 for the treatment of refractory diabetic foot ulcers compared with standard of care. The trial is Phase 1, actively recruiting, and plans to enroll 120 participants in Australia.