Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)
Condition(s) studied
Investigational drug(s) / intervention(s)
Telacebec: The test product will be supplied as Telacebec 100mg tablets.
Study summary
The goal of this interventional clinical trial is to demonstrate the complete BU lesion healing rate by 52 weeks after treatment initiation, without relapse and/or curative intent excision surgery, after 10-28 days of telacebec (T) treatment. Males and females age 18 and older will be included.
• Participants will attend visits every 2 weeks during treatment and thereafter every 2 weeks until week 24 Thereafter they will be followed by visits at weeks 30, 40, and 52. From week 10 to week 52, if the lesion has healed, follow-up visits may be remote.
Eligibility
Primary outcome measure(s)
- Rate of complete lesion healing by 52 weeks from treatment initiation. — 52 weeks from treatment initiation
Ulcerated Lesions: Healing and re-epithelialisation of ulcerated area with stable scar formation. Non-ulcerated Lesions: resolution of induration of skin. Complete healing rate will be summarized as percentage with corresponding Clopper-Pearson 95% confidence interval.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Barwon Health | Geelong | Victoria | Recruiting |
| Royal Melbourne Hospital | Melbourne | Australia | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06481163 on ClinicalTrials.gov ↗ ← All trials in Australia