Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).
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 details:
This is an open label single arm (telacebec), multi-centre, clinical trial. Eligible participants with clinically diagnosed BU. Participants who meet entry criteria and give consent will attend a baseline enrolment visit (Day 1), then visits every week for 2 weeks during treatment (weeks 2, 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Clinical diagnosis of BU
- Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).
Exclusion criteria
- Participants with the following known or suspected medical conditions:
- 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]
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT06481163
Intervention or treatment
DRUG: Telacebec
Conditions
- Buruli Ulcer
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Barwon Health
Select from list below to view details:
Barwon Health
Geelong, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Australia
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Who is running the clinical trial?
Barwon Health
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: 100 or 300 mg Telacebec per day
| Drug: Telacebec |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
References
Clinical Trials Gov: Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).Other trials to consider
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