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RECRUITING
NCT06481163
PHASE2

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

Sponsor: Barwon Health

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-07-09

Completion Date

2026-12

Last Updated

2025-12-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

Telacebec

The test product will be supplied as Telacebec 100mg tablets.

Locations (2)

Barwon Health

Geelong, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Australia