NCT06058299Active, not recruitingPhase 2
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
A Phase 2, Partially-blinded, Randomised Trial Assessing the Safety and Efficacy of TBAJ-876 or Bedaquiline, in Combination With Pretomanid and Linezolid in Adult Participants With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 309 (actual)
- First submitted
- 22 Sept 2023
- Start date
- 31 Oct 2023
- Primary completion date
- 27 Dec 2024
- Lead sponsor
- Global Alliance for TB Drug Development
- Diseases
- Tuberculosis
- NCT number
- NCT06058299
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 309
- From 31 Oct 2023 to the primary completion date, 27 Dec 2024
- 22 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant does not agree to use DTG/TFV/3TC during trial if ARV therapy is indicated, and randomised to the TBAJ876 or the B-Pa-L regimen
- If initiation of ARV therapy is indicate, participants who are known to be intolerant, non-responsive to DTG/TFV/3TC or have DTG/TFV/3TC as a contraindication.
Other illness
- Positive results at screening for HBsAg, HAV IgM, or hepatitis C antibodies
- For participants living with HIV only:
- WHO Clinical Stage 4 HIV disease
Lab values
- Cardiovascular or QT prolongation risk factors
- Platelets \<100,000/mm³
- Creatinine \>1.3 x ULN
- Haemoglobin \<9.5 g/dL or \<95 g/L
- Absolute neutrophil count \<800/mm³
- Serum potassium less than the lower limit of normal for the laboratory.
- ALT and/or AST ≥2.5 x ULN
- Total bilirubin ≥1.6 x ULN
- Direct bilirubin \>1 x ULN
- Haemoglobin A1c ≥8.0%
- Total lipase ≥1.5 x ULN
- Total amylase ≥1.5 x ULN
- CPK \>3 x ULN (if \>3 x ULN, enquire about the participant's recent strenuous activity and consider repeating the test within the screening window)
- TSH \>1 x ULN
- CD4+ count\<200 cells/μL.
Other
- Karnofsky score \< 60 at screening
- Any evidence of extrapulmonary TB
- Pregnant or breast-feeding
- Any of the following lab toxicities:
Who the study is looking for
- Signed informed consent
- DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB
- Of non-childbearing potential OR using effective birth control methods
- Body weight ≥ 35 kg
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Center for Tuberculosis and Lung Diseases Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| CARE Clinical Trial Group Inc. Coordinator of this site? Confirm its status | Dasmariñas | Philippines | Unknown status |
| Tropical Disease Foundation Coordinator of this site? Confirm its status | Makati City | Philippines | Unknown status |
| Lung Center of the Philippines Coordinator of this site? Confirm its status | Quezon City | Philippines | Unknown status |
| NIMR-Mbeya Medical Research Center Coordinator of this site? Confirm its status | Mbeya | Tanzania | Unknown status |
| Kilimanjaro Christian Medical Centre Coordinator of this site? Confirm its status | Moshi | Tanzania | Unknown status |
| National Institute for Medical Research (NIMR) Coordinator of this site? Confirm its status | Mwanza | Tanzania | Unknown status |
| Case Western Reserve University- Research collaboration Uganda Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Joint Clinical Research Centre (JCRC) Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Madibeng Centre for Research Coordinator of this site? Confirm its status | Brits | South Africa | Unknown status |
| University of Cape Town Lung Institute (UCTLI) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| TASK Brooklyn Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Desmond Tutu Health Foundation Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Enhancing Care Foundation Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Synergy Biomed Research Institute (SBRI) Coordinator of this site? Confirm its status | East London | South Africa | Unknown status |
| Task Eden Coordinator of this site? Confirm its status | George | South Africa | Unknown status |
| TB and HIV Investigative Network (THINK) Coordinator of this site? Confirm its status | Hillcrest | South Africa | Unknown status |
| WITS, Clinical HIV Research Unit (CHRU) Themba Lethu Clinic, Helen Joseph Hospital Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Perinatal HIV Research Unit (PHRU) Coordinator of this site? Confirm its status | Klerksdorp | South Africa | Unknown status |
| Isango Lethemba TB Research Unit Coordinator of this site? Confirm its status | Port Elizabeth | South Africa | Unknown status |
| The Aurum Institute Coordinator of this site? Confirm its status | Rustenburg | South Africa | Unknown status |
| Setshaba Research Centre Coordinator of this site? Confirm its status | Soshanguve | South Africa | Unknown status |
Related publications
- Cardiodynamic evaluation of sorfequiline (TBAJ-876): results from a first-in-human study.Antimicrob Agents Chemother · 2026 · PMID 41616265
- Protocol for a phase 2, partially blinded, randomized trial assessing the safety and efficacy of sorfequiline or bedaquiline in combination with pretomanid and linezolid in adult participants with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis (NC-009).Trials · 2026 · PMID 41495827
This page is information, not medical advice. Discuss any trial with your doctor.