Share
Save
Telacebec (T) Treatment in Adults with Buruli Ulcer (BU).
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: Telacebec
|
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
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!