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Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Results first posted: Jun 24, 2026
    • Start date: Oct 24, 2023 to Oct 31, 2023
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: details revised at 1 of 3 entries
    v8
  2. Primary endpoint revisedv7 Show 4 more changesShow less
    • Study completion date: Jun 2026 to Feb 2027
    • Interventions: Bedaquiline (Drug), HR (Drug), HRZE (Drug), Linezolid (Drug), Pretomanid (Drug), TBAJ-876 (Drug) to Bedaquiline (Drug), HR (Drug), HRZE (Drug), Linezolid (Drug), Pretomanid (Drug), sorfequiline (Drug)
    • Secondary endpoint revised
    • Site details revised at 1 of 22 sites
  3. Primary completion date changed from estimate of Jan 2025 to Dec 27, 2024v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 300 to confirmed 309
    • Primary completion date: Feb 2025 to Jan 2025
    • Study sites revised (22)
    v5
  5. Site details revised at 2 of 22 sitesv4
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  1. Study sites: 21 to 22v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jan 2025 to Feb 2025
    • Start date changed from estimate of Oct 2023 to Oct 24, 2023
    • Site details revised at 21 of 21 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult participants with newly diagnosed, smear-positive, pulmonary drug sensitive tuberculosis (DS-TB). The main questions the trial aims to answer are: * What is the optimal dose of TBAJ876 to continue further in development. * What is the bactericidal activity of bedaquiline with pretomanid and linezolid (B-Pa-L) compared to 2HRZE and TBAJ876-Pa-L over 8 weeks * What is the efficacy and safety of the 26-week B-Pa-L regimen compared with the SOC (2HRZE/4HR) in participants with DS-TB. Participants will be seen regularly during treatment (up to 26 weeks) and follow-up (52 weeks post treatment) for safety and efficacy assessments, including but not limited to: * Safety labs, ECGs, vital signs, physical exams, PK sampling, neuropathy assessments and adverse event monitoring * Sputum collection
Trial Details
NCT Number NCT06058299
Lead Sponsor Global Alliance for TB Drug Development
Conditions
(from sponsor)		 Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
Related terms Tuberculosis, Tuberculosis, Pulmonary
Enrollment 309 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov