Buruli UlcerPhase 2NCT06481163
Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)
A Phase 2 study testing Telacebec in people with Buruli Ulcer, run by Barwon Health at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Buruli Ulcer
- What is being tested?
- Telacebec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesAustralia
- Study dates
- 9 Jul 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- 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.
- History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mls/min],
- Compromised immune status (e.g. uncontrolled HIV-infection)
- History of previous BU in the previous 12 months (except current infection)
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Barwon Health
Geelong, Victoria, 3220
Daniel O'Brien, +61 3 4215 2375, daniel.o'brien@barwonhealth.org.au
- Recruiting
Royal Melbourne Hospital
Melbourne
Stephen Muhi, MD, 03 9342 9018, stephen.muhi@mh.org.ua
About this study
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.
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.
Read the 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.
- Conditions
- Buruli Ulcer
- Being tested
- Telacebec
- Keywords
- lesion, ulcer, Buruli Ulcer, telacebec, Q203
- Medical subject headings
- Buruli Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelacebecDrug
Also called Q203
The test product will be supplied as Telacebec 100mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| 100 or 300 mg Telacebec per day | Experimental | Telacebec will be administered orally with food once daily for 10-28 consecutive days. Receives: Drug: Telacebec |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks from treatment initiation
Secondary outcomes (2)
Median time to healing
Kaplan-Meier methods will be applied to estimate median time to healing.
Measured: 52 weeks from treatment initiation
Safety and Tolerability
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Time of first dose to 28 days after last dose of telacebec.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start9 Jul 2024
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buruli UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barwon Health
- Sponsor type
- Other government
- Collaborators
- Global Alliance for TB Drug Development
- Responsible party
- Sponsor
- Investigators
- Daniel O'Brien, MD, Principal investigator, Barwon Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481163
- Sponsor's protocol ID
- TBA-BU-01
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing platform is not available yet.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06481163
- Acronym / sponsor ID
- TBA-BU-01
- Conditions
- Buruli Ulcer
- Keywords
- lesion, ulcer, Buruli Ulcer, telacebec, Q203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Barwon HealthOther government
- Collaborators
- Global Alliance for TB Drug Development
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| 100 or 300 mg Telacebec per day | Experimental | Drug: TelacebecTelacebec will be administered orally with food once daily for 10-28 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelacebecAlso: Q203The test product will be supplied as Telacebec 100mg tablets. | Drug | 100 or 300 mg Telacebec per day |
Primary outcome
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.
2 secondary outcomes
Median time to healing
Time frame: 52 weeks from treatment initiation
Safety and Tolerability
Time frame: Time of first dose to 28 days after last dose of telacebec.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. Data sharing platform is not available yet.
Related trials for Buruli Ulcer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel O'Brien, MD principal investigator
Barwon Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telacebec in people with Buruli Ulcer, run by Barwon Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bree Sarah (+61 (03) 4215 3035, BREE.SARAH@barwonhealth.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete lesion healing by 52 weeks from treatment initiation. (time frame: 52 weeks from treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.