Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
TBAJ-876 or Bedaquiline + Pretomanid + Linezolid in Pulmonary Tuberculosis
NCT06058299Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2023
- Primary completion
- Dec 2024
- Countries
- 5
- Sponsor
- TB Alliance
- Modality
- Small Molecules
- Drugs
- sorfequiline
- Conditions
- pulmonary tuberculosis (TB)
01
Overview
Phase 2, randomised, double-blind trial of sorfequiline in pulmonary tuberculosis (TB) (5 arms), sponsored by TB Alliance. Primary endpoint: Proportion of Participants With Stable Sputum Conversion at 8 weeks. Started Oct 2023; status: active, not recruiting.
02
Design
5 arms- Study design
- RandomizedDouble-blind
S 25 mg + Pa + L -> HR
sorfequiline 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
S 50 mg + Pa + L -> HR
sorfequiline 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
S 100 mg + Pa + L -> HR
sorfequiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
B + Pa + L -> B + Pa + L
Bedaquiline 200 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by bedaquiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 18 weeks
HRZE -> HR
Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks
03
Who it enrols
Adults with newly diagnosed or previously cured (untreated for >=3 years) drug-sensitive pulmonary TB, weighing >=35 kg, with Karnofsky score >=60, and adequate organ function. Excludes pregnant/breastfeeding women, those with extrapulmonary TB, cardiovascular/QT prolongation risks, or active hepatitis.
04
Endpoints
Primary
Proportion of Participants With Stable Sputum Conversion
Secondary
Favorable Outcome 26 Weeks After End of Treatment
Beyond the preview
Go deeper on NCT06058299.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT06058299.