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

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 determine if treatment with 2-4 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.

Study Overview

• Status: Recruiting
• Conditions: Buruli Ulcer
• Intervention / Treatment: Drug: Telacebec

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 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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bree Sarah; Phone Number: +61 (03) 4215 3035; Email: BREE.SARAH@barwonhealth.org.au
• Study Contact Backup: Name: Kate Ellis; Phone Number: +61 (03) 4215 2878; Email: KATHRYN.ELLIS@barwonhealth.org.au

Study Locations

• Australia
  • Melbourne, Australia
    • Recruiting
    • Royal Melbourne Hospital
    • Contact: Stephen Muhi, MD; Phone Number: 03 9342 9018; Email: stephen.muhi@mh.org.ua
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Recruiting
      • Barwon Health
      • Contact: Daniel O'Brien; Phone Number: +61 3 4215 2375; Email: daniel.o'brien@barwonhealth.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Major 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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 14-28 consecutive days.	Drug: Telacebec; The test product will be supplied as Telacebec 100mg tablets.; Other Names: Q203

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Measures

Outcome Measure	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
Safety and Tolerability	Incidence of Treatment Emergent Adverse Events (TEAEs)	Time of first dose to 28 days after last dose of telacebec.

Collaborators and Investigators

• Sponsor: Barwon Health
• Collaborators: Global Alliance for TB Drug Development
• Investigators: Principal Investigator: Daniel O'Brien, MD, Barwon Health

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: ulcer; lesion; Buruli Ulcer; telacebec; Q203
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Skin Diseases; Skin Ulcer; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Ulcer; Buruli Ulcer; telacebec
• Other Study ID Numbers: TBA-BU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request and subject to approval by the Sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No