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

NCT06481163 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TBA-BU-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Buruli Ulcer

Keywords

lesion; ulcer; Buruli Ulcer; telacebec; Q203

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Median time to healing

  52 weeks from treatment initiation

• Safety and Tolerability

  Time of first dose to 28 days after last dose of telacebec.

Study Arms (1)

100 or 300 mg Telacebec per day

EXPERIMENTAL

Telacebec will be administered orally with food once daily for 10-28 consecutive days.

Drug: Telacebec

Interventions

Telacebec DRUG

The test product will be supplied as Telacebec 100mg tablets.

Also known as: Q203

100 or 300 mg Telacebec per day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of BU WHO categories, single or multiples:
• Category I- a single lesion \< 5 cm Category II - a single lesion with cross-sectional diameter ≤ 10 cm Category III - where multiple and all lesions are ≤ 10 cm cross-sectional diameter
• Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).

You may not qualify if:

• Participants with the following known or suspected medical conditions/criteria:
• 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 \[estimated glomerular filtration rate (eGFR) \< 30 mls/min\],
• Compromised immune status (e.g. uncontrolled HIV-infection)
• History of previous BU in the previous 12 months (except current infection)
• Participants who fulfill both of the following criteria:
• Aged ≥ 60 years
• Weight ≥ 85 kg
• 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.

Sponsors & Collaborators

• Barwon Health: lead
• Global Alliance for TB Drug Development: collaborator

Study Sites (2)

Barwon Health

Geelong, Victoria, 3220, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Australia

RECRUITING

MeSH Terms

Conditions

Buruli Ulcer; Ulcer

Interventions

telacebec

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel O'Brien, MD

  Barwon Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bree Sarah

CONTACT

+61 (03) 4215 3035; BREE.SARAH@barwonhealth.org.au

Kate Ellis

CONTACT

+61 (03) 4215 2878; KATHRYN.ELLIS@barwonhealth.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 1, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)