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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06481163




Registration number
NCT06481163
Ethics application status
Date submitted
21/06/2024
Date registered
1/07/2024
Date last updated
19/09/2024

Titles & IDs
Public title
Telacebec (T) Treatment in Adults with Buruli Ulcer (BU).
Scientific title
A Phase 2 Multicentre, Open-label Study to Evaluate the Efficacy, Safety and Tolerability, and Pharmacokinetics of 28 Days Telacebec Treatment in Adult Participants with Buruli Ulcer.
Secondary ID [1] 0 0
TBA-BU-01
Universal Trial Number (UTN)
Trial acronym
TREAT-BU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Buruli Ulcer 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Telacebec

Experimental: 300 mg Telacebec per day - Telacebec will be administered orally with food or within 30 minutes after food once daily for 28 consecutive days.


Treatment: Drugs: Telacebec
The test product will be supplied as Telacebec 100mg tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of complete lesion healing by 52 weeks from treatment initiation.
Timepoint [1] 0 0
52 weeks from treatment initiation
Secondary outcome [1] 0 0
Complete lesion healing rate at 52 weeks from treatment initiation.
Timepoint [1] 0 0
52 weeks from treatment initiation
Secondary outcome [2] 0 0
Median time to healing
Timepoint [2] 0 0
52 weeks from treatment initiation
Secondary outcome [3] 0 0
Recurrence rate within 52 weeks from treatment initiation
Timepoint [3] 0 0
52 weeks from treatment initiation
Secondary outcome [4] 0 0
Treatment failure rate within 52 weeks from treatment initiation
Timepoint [4] 0 0
52 weeks from treatment initiation
Secondary outcome [5] 0 0
Paradoxical response rate with 52 weeks from treatment initiation
Timepoint [5] 0 0
52 weeks from treatment initiation

Eligibility
Key inclusion criteria
Major

* Clinical diagnosis of BU WHO categories, single or multiples:

1. I
2. II with a cross-sectional diameter < 10 cm
3. III category III lesions where multiple and all are < 10 cm cross-sectional diameter
* Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).

Major
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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) < 50 mls/min], uncontrolled diabetes mellitus [glycated heaemoglobin (HbA1C )> 10%], and severe immune compromise (e.g., immunosuppressive drugs after organ transplant)
3. History of previous BU (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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Barwon Health - Geelong
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Barwon Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Global Alliance for TB Drug Development
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/study/NCT06481163
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel O&amp;#39;Brien
Address 0 0
Barwon Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bree Sarah
Address 0 0
Country 0 0
Phone 0 0
+61 (03) 4215 3035
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06481163