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

June 29, 2026 updated by: Barwon Health

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 will receive telacebec 300 mg orally once daily for 14-28 days with food (protocol V2.0 - 6.0) or telacebec 100 mg orally once daily for 10 days with food (protocol V7.0).

Participants who meet entry criteria and give consent will attend a baseline enrolment visit (Day 1), then visits every week for 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 review efficacy and safety data. Enrolment and enrolled participants will continue the study whilst the DRC reviews are ongoing.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Major Inclusion Criteria:

  • Clinical diagnosis of BU WHO categories, single or multiples:

Category I- a single lesion < 5 cm Category II - a single lesion with cross-sectional diameter ≤ 10 cm Category III - where multiple and all lesions are ≤ 10 cm cross-sectional diameter

  • Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).
  • Aged 18 years and older, except for those included in exclusion below.

Major Exclusion Criteria:

  • Participants with the following known or suspected medical conditions/criteria:

    1. Any non BU related condition where participation in the study, as judged by the Investigator, could compromise the well-being of the participant or prevent, limit or confound protocol specified treatment and assessments.
    2. History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mls/min],
    3. Compromised immune status (e.g. uncontrolled HIV-infection)
    4. History of previous BU in the previous 12 months (except current infection)

    5. Participants who fulfill both of the following criteria:

      • Aged ≥ 60 years
      • Weight ≥ 85 kg
  • Planned/expected to require curative intent excision surgery, defined as excision of lesion which may include surrounding macroscopically healthy tissue with the aim of helping to sterilize the wound rather than improve wound healing alone, for their BU during the entire study period. Simple removal of necrotic slough and skin grafting is considered normal wound care and allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100 or 300 mg Telacebec per day
Telacebec will be administered orally with food once daily for 10-28 consecutive days.
Drug: Telacebec
The test product will be supplied as Telacebec 100mg tablets.
Other Names:
  • Q203

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complete lesion healing by 52 weeks from treatment initiation.
Time Frame: 52 weeks from treatment initiation

Ulcerated Lesions: Healing and re-epithelialisation of ulcerated area with stable scar formation. Non-ulcerated Lesions: resolution of induration of skin.

Complete healing rate will be summarized as percentage with corresponding Clopper-Pearson 95% confidence interval.
52 weeks from treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median time to healing
Time Frame: 52 weeks from treatment initiation
Kaplan-Meier methods will be applied to estimate median time to healing.
52 weeks from treatment initiation
Safety and Tolerability
Time Frame: Time of first dose to 28 days after last dose of telacebec.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time of first dose to 28 days after last dose of telacebec.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barwon Health

Collaborators

Global Alliance for TB Drug Development

Investigators

  • Principal Investigator: Daniel O'Brien, MD, Barwon Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBA-BU-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing platform is not available yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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