Pulmonary TBPhase 2NCT06058299
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
A Phase 2 study testing sorfequiline, Pretomanid and Linezolid in people with Pulmonary TB and Pulmonary Tuberculosis, run by Global Alliance for TB Drug Development at 22 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
- What is being tested?
- sorfequiline, Pretomanid and Linezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 31 Oct 2023to Feb 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Karnofsky score < 60 at screening
- Any evidence of extrapulmonary TB
- Cardiovascular or QT prolongation risk factors
- Pregnant or breast-feeding
- Any of the following lab toxicities:
- Platelets <100,000/mm³
Show all 24Show fewer
- 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
- Positive results at screening for HBsAg, HAV IgM, or hepatitis C antibodies
- For participants living with HIV only:
- CD4+ count<200 cells/μL.
- WHO Clinical Stage 4 HIV disease
- 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.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
South Africa13 sites
Madibeng Centre for Research
Brits, 0250
TASK Brooklyn
Cape Town, 7405
University of Cape Town Lung Institute (UCTLI)
Cape Town, 7700
Desmond Tutu Health Foundation
Cape Town, 7750
Enhancing Care Foundation
Durban, 4052
Synergy Biomed Research Institute (SBRI)
East London, 5201
TASK Eden
George, 6529
TB and HIV Investigative Network (THINK)
Hillcrest, 3610
WITS, Clinical HIV Research Unit (CHRU) Themba Lethu Clinic, Helen Joseph Hospital
Johannesburg, 2092
Perinatal HIV Research Unit (PHRU)
Klerksdorp, 2571
Isango Lethemba TB Research Unit
Port Elizabeth, 6200
The Aurum Institute
Rustenburg, 2999
Setshaba Research Centre
Soshanguve, Gauteng, 0152
Philippines3 sites
Care Clinical Trial Group Inc.
Dasmariñas, 4114
Tropical Disease Foundation
Makati City, 1230
Lung Center of the Philippines
Quezon City, 1104
Tanzania3 sites
NIMR-MBEYA Medical Research Center
Mbeya
Kilimanjaro Christian Medical Centre
Moshi
National Institute for Medical Research (NIMR)
Mwanza
Uganda2 sites
Case Western Reserve University- Research collaboration Uganda
Kampala
Joint Clinical Research Centre (JCRC)
Kampala
Georgia1 site
National Center for Tuberculosis and Lung Diseases
Tbilisi, 0101
About this study
Official title: 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
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:
Read more
- 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
Read the detailed description
Participants will be treated up to 26 weeks with either:
- TBAJ876 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
- TBAJ876 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
- TBAJ876 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
- 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
- Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participant's weight).
TBAJ876 and bedaquiline will be blinded during the first 8 weeks of trial treatment; participants randomised to the TBAJ876 or bedaquiline arms will receive open-label pretomanid and linezolid. Participants randomised to the 2HRZE/4HR arm will receive open-label HRZE.
After receiving 8 weeks of treatment, participants randomised to the TBAJ876-Pa-L treatment arms will receive open-label HR for at least 7 weeks. Treatment completion will be allowed at Week 15 in participants randomised to the TBAJ876-Pa-L arms, if the below criteria are met:
- Week 8 or EOT Make-up Period 1 sputum MGIT culture is negative, and
- The participant has no TB-related symptoms by Week 15. Participants with symptoms that have a more likely alternative explanation are eligible to complete treatment at Week 15.
If the MGIT result is MTB positive and/or there are still TB symptom(s), participants will continue to receive HR (in the 3 TBAJ876 arms) and will complete 18 weeks of treatment with HR, for a total of 26 weeks of treatment. After receiving 8 weeks of trial treatment, all participants randomised to the HRZE arm will receive open-label HR for 18 weeks, for a total of 26 weeks of treatment. After receiving 8 weeks of treatment, a participants randomised to the B-Pa-L arm will receive open-label bedaquiline 100 mg (a reduction from the 200 mg daily dose in the first 8 weeks), pretomanid 200 mg, and linezolid 600 mg daily for 18 weeks, for a total of 26 weeks of trial treatment.
- Being tested
- sorfequiline, Pretomanid, Linezolid, Bedaquiline, HRZE
- Keywords
- sorfequiline, Tuberculosis, pretomanid, bedaquiline, linezolid, TBAJ876
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorfequilineDrug
Also called TBAJ876
tablet
PretomanidDrug
Also called PA-824, Dovprela
tablet
LinezolidDrug
Also called Zyvox
tablet
BedaquilineDrug
Also called Sirturo, TMC207
tablet
HRZEDrug
Also called Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E)
fixed doe combination tablets
HRDrug
Also called Isoniazid (H), Rifampicin R)
fixed dose combination tablets
| Study group | Role | What they receive |
|---|---|---|
| S 25 mg + Pa 200 mg +L 600 mg for 8 weeks followed by HR for 7 to 18 weeks | Experimental | sorfequiline 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks Receives: Drug: sorfequiline; Drug: Pretomanid; Drug: Linezolid; Drug: HR |
| S 50 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks | Experimental | sorfequiline 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks Receives: Drug: sorfequiline; Drug: Pretomanid; Drug: Linezolid; Drug: HR |
| S 100 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks | Experimental | sorfequiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks Receives: Drug: sorfequiline; Drug: Pretomanid; Drug: Linezolid; Drug: HR |
| B 200 mg + Pa 200 mg +L 600 mg for 8 weeks followed by B 100 mg + Pa 200 mg + L 600 mg for 18 weeks | Active comparator | 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 Receives: Drug: Pretomanid; Drug: Linezolid; Drug: Bedaquiline |
| IH + R + Z + E for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). | Active comparator | Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). Receives: Drug: HRZE; Drug: HR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Stable Sputum Conversion by 8 Weeks,
Kaplan Meir estimates of proportion participants with stable sputum culture conversion (SCCC) to negative by 8 weeks of treatment.
Measured: Through 8 weeks of treatment
Secondary outcomes (1)
Favorable Outcome 26 Weeks After End of Treatment
Proportion of participants with a favorable outcome at 26 weeks after the end of treatment.
Measured: 26 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start31 Oct 2023
- Primary completion27 Dec 2024
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who meet all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1:1:1:1 ratio using an interactive response technology that stratifies based on country and severity of disease (AFB 3+ and/or bilateral cavitation) to 1 of the 5 treatment arms:
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Alliance for TB Drug Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morounfolu Olugbosi, MD, Study director, TB Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058299
- Sponsor's protocol ID
- NC-009
- Status last verified
- May 2026
- First submitted
- 22 Sep 2023
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The results of this trial may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to TB Alliance before submission. This allows TB Alliance to protect proprietary information and to provide comments; such consent will not be withheld unreasonably
Publications
Olugbosi M, Beumont M, Lombard L, Nedelman J, Timm J, Black T, Bruning-Barry R, Hickman D, Lombardi A, Betteridge M, Egizi E, Marcopulos L, Henderson J, Seidel S, Foraida S, Benhayoun M, Sun E. 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 Jan 6;27(1):102. doi: 10.1186/s13063-025-09413-5.
PubMed 41495827Darpo B, Nedelman J, Bruning-Barry R, Hickman D, Kleiman R, Lombardi A, Xue H. Cardiodynamic evaluation of sorfequiline (TBAJ-876): results from a first-in-human study. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0127325. doi: 10.1128/aac.01273-25. Epub 2026 Jan 30.
PubMed 41616265Komm OD, Tyagi S, Garcia A, Almeida D, Chang Y, Li S-Y, Castillo JR, Converse PJ, Black T, Fotouhi N, Nuermberger EL. Contribution of telacebec to novel drug regimens in a murine tuberculosis model. Antimicrob Agents Chemother. 2025 Jan 31;69(1):e0096224. doi: 10.1128/aac.00962-24. Epub 2024 Dec 9.
PubMed 39651910
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06058299
- Acronym / sponsor ID
- NC-009
- Keywords
- sorfequiline, Tuberculosis, pretomanid, bedaquiline, linezolid, TBAJ876
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Global Alliance for TB Drug DevelopmentUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Posted 24 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Participants will be treated up to 26 weeks with either:
- TBAJ876 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
- TBAJ876 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
- TBAJ876 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks
- 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
- Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participant's weight).
TBAJ876 and bedaquiline will be blinded during the first 8 weeks of trial treatment; participants randomised to the TBAJ876 or bedaquiline arms will receive open-label pretomanid and linezolid. Participants randomised to the 2HRZE/4HR arm will receive open-label HRZE.
After receiving 8 weeks of treatment, participants randomised to the TBAJ876-Pa-L treatment arms will receive open-label HR for at least 7 weeks. Treatment completion will be allowed at Week 15 in participants randomised to the TBAJ876-Pa-L arms, if the below criteria are met:
- Week 8 or EOT Make-up Period 1 sputum MGIT culture is negative, and
- The participant has no TB-related symptoms by Week 15. Participants with symptoms that have a more likely alternative explanation are eligible to complete treatment at Week 15.
If the MGIT result is MTB positive and/or there are still TB symptom(s), participants will continue to receive HR (in the 3 TBAJ876 arms) and will complete 18 weeks of treatment with HR, for a total of 26 weeks of treatment. After receiving 8 weeks of trial treatment, all participants randomised to the HRZE arm will receive open-label HR for 18 weeks, for a total of 26 weeks of treatment. After receiving 8 weeks of treatment, a participants randomised to the B-Pa-L arm will receive open-label bedaquiline 100 mg (a reduction from the 200 mg daily dose in the first 8 weeks), pretomanid 200 mg, and linezolid 600 mg daily for 18 weeks, for a total of 26 weeks of trial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Participants who meet all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1:1:1:1 ratio using an interactive response technology that stratifies based on country and severity of disease (AFB 3+ and/or bilateral cavitation) to 1 of the 5 treatment arms:
| Arm | Type | Receives |
|---|---|---|
| S 25 mg + Pa 200 mg +L 600 mg for 8 weeks followed by HR for 7 to 18 weeks | Experimental | Drug: sorfequiline, Drug: Pretomanid, Drug: Linezolid, Drug: HRsorfequiline 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks |
| S 50 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks | Experimental | Drug: sorfequiline, Drug: Pretomanid, Drug: Linezolid, Drug: HRsorfequiline 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks |
| S 100 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks | Experimental | Drug: sorfequiline, Drug: Pretomanid, Drug: Linezolid, Drug: HRsorfequiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks |
| B 200 mg + Pa 200 mg +L 600 mg for 8 weeks followed by B 100 mg + Pa 200 mg + L 600 mg for 18 weeks | Active comparator | Drug: Pretomanid, Drug: Linezolid, Drug: BedaquilineBedaquiline 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 |
| IH + R + Z + E for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). | Active comparator | Drug: HRZE, Drug: HRIsoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- Karnofsky score < 60 at screening
- Any evidence of extrapulmonary TB
- Cardiovascular or QT prolongation risk factors
- Pregnant or breast-feeding
- Platelets <100,000/mm³
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sorfequilineAlso: TBAJ876tablet | Drug | S 100 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks, S 25 mg + Pa 200 mg +L 600 mg for 8 weeks followed by HR for 7 to 18 weeks, S 50 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks |
| PretomanidAlso: PA-824, Dovprelatablet | Drug | B 200 mg + Pa 200 mg +L 600 mg for 8 weeks followed by B 100 mg + Pa 200 mg + L 600 mg for 18 weeks, S 100 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks, S 25 mg + Pa 200 mg +L 600 mg for 8 weeks followed by HR for 7 to 18 weeks, S 50 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks |
| LinezolidAlso: Zyvoxtablet | Drug | B 200 mg + Pa 200 mg +L 600 mg for 8 weeks followed by B 100 mg + Pa 200 mg + L 600 mg for 18 weeks, S 100 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks, S 25 mg + Pa 200 mg +L 600 mg for 8 weeks followed by HR for 7 to 18 weeks, S 50 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks |
| BedaquilineAlso: Sirturo, TMC207tablet | Drug | B 200 mg + Pa 200 mg +L 600 mg for 8 weeks followed by B 100 mg + Pa 200 mg + L 600 mg for 18 weeks |
| HRZEAlso: Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E)fixed doe combination tablets | Drug | IH + R + Z + E for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). |
| HRAlso: Isoniazid (H), Rifampicin R)fixed dose combination tablets | Drug | IH + R + Z + E for 8 weeks followed by HR for 18 weeks (dose based on participant's weight)., S 100 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks, S 25 mg + Pa 200 mg +L 600 mg for 8 weeks followed by HR for 7 to 18 weeks, S 50 mg + Pa 200 mg + L 600 mg for 8 weeks followed by HR for 7 to 18 weeks |
Primary outcome
Proportion of Participants With Stable Sputum Conversion by 8 Weeks,
Time frame: Through 8 weeks of treatment
Kaplan Meir estimates of proportion participants with stable sputum culture conversion (SCCC) to negative by 8 weeks of treatment.
1 secondary outcome
Favorable Outcome 26 Weeks After End of Treatment
Time frame: 26 weeks after end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 41495827Olugbosi M, Beumont M, Lombard L, Nedelman J, Timm J, Black T, Bruning-Barry R, Hickman D, Lombardi A, Betteridge M, Egizi E, Marcopulos L, Henderson J, Seidel S, Foraida S, Benhayoun M, Sun E. 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 Jan 6;27(1):102. doi: 10.1186/s13063-025-09413-5.
- Derived from this study: PubMed 41616265Darpo B, Nedelman J, Bruning-Barry R, Hickman D, Kleiman R, Lombardi A, Xue H. Cardiodynamic evaluation of sorfequiline (TBAJ-876): results from a first-in-human study. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0127325. doi: 10.1128/aac.01273-25. Epub 2026 Jan 30.
- Derived from this study: PubMed 39651910Komm OD, Tyagi S, Garcia A, Almeida D, Chang Y, Li S-Y, Castillo JR, Converse PJ, Black T, Fotouhi N, Nuermberger EL. Contribution of telacebec to novel drug regimens in a murine tuberculosis model. Antimicrob Agents Chemother. 2025 Jan 31;69(1):e0096224. doi: 10.1128/aac.00962-24. Epub 2024 Dec 9.
- NC-009 Protocol DescriptionLink provided by the sponsor.
- NC-009 Week 8 Interim Analysis ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The results of this trial may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to TB Alliance before submission. This allows TB Alliance to protect proprietary information and to provide comments; such consent will not be withheld unreasonably
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morounfolu Olugbosi, MD study director
TB Alliance
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sorfequiline, Pretomanid and Linezolid in people with Pulmonary TB and Pulmonary Tuberculosis, run by Global Alliance for TB Drug Development at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in South Africa, Philippines, Tanzania, Uganda, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Stable Sputum Conversion by 8 Weeks, (time frame: Through 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058299, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.