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

Phase 2

Recruiting

• Conditions: Buruli Ulcer
• Interventions: Drug: Telacebec

• Registration Number: NCT06481163
• Lead Sponsor: Barwon Health

Brief Summary

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 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), 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.

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-01
• Study Start: 2024-07-09
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clinical diagnosis of BU
• Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).

Major

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.
  2. History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mls/min],
  3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
300 mg Telacebec per day	Telacebec	Telacebec will be administered orally with food or within 30 minutes after food once daily for 28 consecutive days.

Primary Outcome Measures

Name	Time	Method
Rate of complete lesion healing by 52 weeks from treatment initiation.	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.

Secondary Outcome Measures

Name	Time	Method
Median time to healing	52 weeks from treatment initiation	Kaplan-Meier methods will be applied to estimate median time to healing.
Recurrence rate within 52 weeks from treatment initiation	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.
Treatment failure rate within 52 weeks from treatment initiation	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

Trial Locations

Locations (2)

Barwon Health; 🇦🇺 Geelong, Victoria, Australia

Royal Melbourne Hospital; 🇦🇺 Melbourne, Australia