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Telacebec (T) Treatment in Adults with Buruli Ulcer (BU).

PHASE2RECRUITING

The goal of this interventional clinical trial is to determine if treatment with 4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. Males and females age 18 and older will be included. * Participants will attend visits every week during treatment (4 weeks) * Thereafter they will be followed every 2 weeks until week 24 followed by visits as weeks 30, 40 and 52.

* Dependent on site requirements, there may be follow up visits on site or remotely.

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Study details:

This is an open label single arm (telacebec), multi-centre, clinical trial. Eligible participants with clinically diagnosed World Health Organization (WHO) category I lesions and category II lesions ≤10 cm cross-sectional diameter and category III lesions where multiple and all lesions are ≤10 cm cross-sectional diameter, confirmed by polymerase chain reaction (PCR) or culture for presence of Mycobacterium ulcerans infection, will receive telacebec 300 mg orally once daily for 28 days with food. Participants who meet entry criteria and give consent will attend a baseline enrolment visit (Day 1), then visits every week for 4 weeks during treatment (weeks 1, 2, 3 and 4).

Thereafter they will be followed up every 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 be established to review efficacy and safety data. Enrolment and enrolled participants will continue the study whilst the DRC reviews are ongoing.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Clinical diagnosis of BU WHO categories, single or multiples: 1. I 2. II with a cross-sectional diameter < 10 cm 3. III category III lesions where multiple and all are < 10 cm cross-sectional diameter

Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).

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.

History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction [estimated glomerular filtration rate (eGFR) < 50 mls/min], uncontrolled diabetes mellitus [glycated heaemoglobin (HbA1C )> 10%], and severe immune compromise (e.g., immunosuppressive drugs after organ transplant)

History of previous BU (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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-07-09

Primary completion: 2024-12-01

Study completion finish: 2025-12-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT06481163

Intervention or treatment

DRUG: Telacebec

Conditions

• Buruli Ulcer

Condition: Buruli Ulcer
DRUG: Telacebec
Melbourne, Not Specified, Australia and more
Sponsor: Barwon Health

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Melbourne Hospital

Research sites nearby

Select from list below to view details:

Royal Melbourne Hospital
Melbourne, Not Specified, Australia
Barwon Health
Geelong, Victoria, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 300 mg Telacebec per day Telacebec will be administered orally with food or within 30 minutes after food once daily for 28 consecutive days.	DRUG: Telacebec The test product will be supplied as Telacebec 100mg tablets.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	52 weeks from treatment initiation

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Complete lesion healing rate at 52 weeks from treatment initiation.	Complete healing rate will be summarized as percentage with corresponding Clopper-Pearson 95% confidence interval.	52 weeks from treatment initiation
Median time to healing	Kaplan-Meier methods will be applied to estimate median time to healing.	52 weeks from treatment initiation
Recurrence rate within 52 weeks from treatment initiation	Complete lesion healing followed by a recurrent lesion at the same site or a new lesion appearing at a separate site, detected within 52 weeks of treatment initiation, that is culture positive and not judged to be due to a paradoxical response to telacebec treatment on clinical and/or histological findings.	52 weeks from treatment initiation
Treatment failure rate within 52 weeks from treatment initiation	Lack of complete healing within the 52 weeks observation period; Recurrence, Use of alternative buruli ulcer (BU) treatment, BU curative intent surgery	52 weeks from treatment initiation
Paradoxical response rate with 52 weeks from treatment initiation	An increase in lesion surface area by more than 20% compared with a previous measurement, after initial reduction in lesion size, or the development of a new lesion appearing at a separate site that does not show evidence of disease relapse on histopathology and/or mycobacterial culture examination.	52 weeks from treatment initiation

Frequently Asked Questions

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References

Clinical Trials Gov: Telacebec (T) Treatment in Adults with Buruli Ulcer (BU).