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

ConditionBuruli Ulcer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarwon Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).

Aged 18 years and older, except for those included in exclusion below.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Telacebec

    Drug

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: 100 or 300 mg Telacebec per dayExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
52 weeks from treatment initiation

Secondary outcomes

1

Median time to healing

Kaplan-Meier methods will be applied to estimate median time to healing.

Time frame
52 weeks from treatment initiation
2

Safety and Tolerability

Incidence of Treatment Emergent Adverse Events (TEAEs)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barwon Health

Lead sponsor

Global Alliance for TB Drug Development

Collaborator

Source ClinicalTrials.gov
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