drugset / Trial / NCT06481163
Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-07-09
- Primary completion
- 2027-12
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telacebec | Small molecule | 100 mg | Oral |
| Subject | Telacebec | Small molecule | 300 mg | Oral |