drugset / Trial / NCT06481163

Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)

NCT06481163

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

EvaluationDrugModalityDoseRoute
Subject Telacebec Small molecule 100 mg Oral
Subject Telacebec Small molecule 300 mg Oral

Indications