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

NCT06481163 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-30

No results posted yet for this 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.

Conditions

  • Buruli Ulcer

Interventions

DRUG

Telacebec

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

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    collaborator OTHER

  • Barwon Health

    lead OTHER_GOV

Principal Investigators

  • Daniel O'Brien, MD · Barwon Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-09
Primary Completion
2027-12-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06481163 on ClinicalTrials.gov