NCT06481163

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

A Phase 2 Multicentre, Open-label Study to Evaluate the Efficacy, Safety and Tolerability, and Pharmacokinetics of 14 -28 Days Telacebec Treatment in Adult Participants With Buruli Ulcer.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Barwon Health · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional clinical trial is to determine if treatment with 2-4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. 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.

Detailed description

This is an open label single arm (telacebec), phase 2 multi-centre, clinical trial. Eligible participants with clinically diagnosed BU, confirmed by polymerase chain reaction (PCR) or culture presence of MU infection Participants who meet entry criteria and give consent will attend a baseline enrolment visit (Day 1), then visits every week for 2 weeks during treatment (weeks 2, and 4). Thereafter they will be followed up every 2 weeks until week 24, followed by visits at weeks 30, 40, and 52. BU lesion management will be provided to all trial participants. In case of participant early withdrawal from the trial during or after the treatment period, participants will be treated per the investigational site and/or country BU treatment guidelines. A Data Review Committee (DRC) will be established to review efficacy and safety data. Enrolment and enrolled participants will continue the study whilst the DRC reviews are ongoing.

Conditions

• Buruli Ulcer

Interventions

Type	Name	Description
DRUG	Telacebec	The test product will be supplied as Telacebec 100mg tablets.

Timeline

• Start date: 2024-07-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-07-01
• Last updated: 2025-12-10

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study