A Phase 2 interventional study of Telacebec in Buruli Ulcer, sponsored by Barwon Health. Recruiting at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Barwon Health · Phase 2, Interventional, and Treatment
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.
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.
359 studies on the registry are indexed under Ulcer; 62 are open to participants now.
This study's planned enrollment of 200 is above the median of 65 across 291 interventional studies indexed under Ulcer.
Browse Ulcer studies →Barwon Health is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Major Inclusion Criteria:
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
Major Exclusion Criteria:
Participants with the following known or suspected medical conditions/criteria:
Participants who fulfill both of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Q203
Rate of complete lesion healing by 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.
Time frame: 52 weeks from treatment initiation
Median time to healing
Kaplan-Meier methods will be applied to estimate median time to healing.
Time frame: 52 weeks from treatment initiation
Safety and Tolerability
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Time of first dose to 28 days after last dose of telacebec.
Plan to share: No — Data sharing platform is not available yet.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Telacebec
Barwon Health