Telacebec treatment for adults with Buruli ulcer

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.

This will try giving adults with Buruli ulcer 2–4 weeks of telacebec to see if it fully heals their lesions by 52 weeks without relapse or surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Barwon Health (Government)
• Locations: 2 sites (Geelong, Victoria and 1 other locations)
• Trial ID: NCT06481163 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm Phase 2 study testing a short course (2–4 weeks) of telacebec (Q203) in adults with clinically diagnosed, PCR- or culture-confirmed Mycobacterium ulcerans infection. Participants attend frequent visits during treatment and regular follow-up through week 52, with remote visits allowed from week 10 if the lesion has healed. Standard lesion management is provided and a Data Review Committee will monitor safety and efficacy while enrollment continues. The trial excludes people with certain comorbidities (for example significant liver disease, renal dysfunction, myasthenia gravis) and those expected to need curative excision surgery during the study.

Who should consider this trial

Good fit: Adults aged 18 or older with a clinical diagnosis of Buruli ulcer confirmed by PCR or culture who do not require planned curative excision surgery are the intended participants.

Not a fit: Patients with significant comorbidities such as ascites, jaundice, myasthenia gravis, severe renal dysfunction (eGFR <30 mL/min), recent BU within 12 months, or those expected to need curative excision are unlikely to benefit from or be eligible for this treatment approach.

Why it matters

Potential benefit: If successful, telacebec could offer a short, non‑surgical treatment that fully heals Buruli ulcer lesions and reduces the need for excision.

How similar studies have performed: Telacebec is a novel anti-mycobacterial agent with promising preclinical and early-phase data but limited prior human experience specifically for Buruli ulcer.

Eligibility criteria

Major Inclusion Criteria:

* Clinical diagnosis of BU
* Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).

Major Exclusion Criteria:

* Participants with the following known or suspected medical conditions:

  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. History of previous BU in the previous 12 months (except current infection)
* 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.

Where this trial is running

Geelong, Victoria and 1 other locations

• Barwon Health — Geelong, Victoria, Australia (Recruiting)
• Royal Melbourne Hospital — Melbourne, Australia (Recruiting)

Study contacts

• Principal investigator: Daniel O'Brien, MD — Barwon Health
• Study coordinator: Bree Sarah

Conditions Buruli Ulcer; lesion; ulcer; telacebec; Q203