Tuberculosis, PulmonaryPhase 2NCT07672405
Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
A Phase 2 study testing sorfequiline, Pretomanid and Linezolid in people with Tuberculosis, Pulmonary, run by Global Alliance for TB Drug Development at 12 sites in 2 countries.
Trial summary
The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200/100SPaL-4/13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis, Pulmonary
- 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
- 100 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 9 Jul 2026to 24 Jun 2028
- Phase
- Phase 2
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
- 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 k
Who cannot join
- Karnofsky score < 60 at screening
- Any evidence of extrapulmonary TB
- Cardiovascular or QT prolongation risk factors Pregnant or breast-feeding
- Laboratory abnormalities as defined in the protocol. • 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 study treatment if ARV therapy is indicated
- If initiation of ARV therapy is indicated, 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
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
South Africa8 sites, 8 recruiting
- Recruiting
Madiberg Centre for Research
Brits, North West Provinvce, 0250
Lindsey Faul, MD, +27 12 252 1140, lfaul@madibengresearch.co.za
Lindsey Faul, MD
- Recruiting
University of Capetown Lung Institute
Cape Town, Mowbray, 7700
Sherman PadayaChee, MD, +27 21 404 7747, Sherman.Padayachee@uct.ac.za
Sherman Padayachee, MD
- Not yet recruiting
Synergy Biomed Research Institute
East London, 5201
Mookho Mallahleha, MD, +27 34 722 2306, drmookho@sbri.org.za
Mookho Malahleha, MD
- Not yet recruiting
Perinatal HIV Research Unit, Tshepong Hospital
Klerksdorp, Northwest Province, 2571
Ebrahim Variava, MD, +27 18 406 3111, variave@phru.co.za
Tumelo Moloantoa, MD, +27 18 011 3800, moloantoat@phru.co.za
- Recruiting
Isango Lethemba TB Research Unit
Port Elizabeth, Eastern Cape, 6200
Simone Faesen, MD, +27 41 492 3195, SimFaesen@witshealth.co.za
Simone Faesen, MD
- Recruiting
The Aurum Institute, Rustenburg
Rustenburg, North West, 2999
William Brumskine, MD
William Brumskine, MD, +27 87 135 1575, wbrumskine@auruminstitute.org
- Recruiting
Setshaba Research Centre
Soshanguve, Gauteng, 0152
Zinhie Zwane, MD, +27 12 799 2422, Zzwane@setshabe.org.za
Zinhle Zwane, MD
- Recruiting
Durban International Clinical Research Site
Wentworth, Durban, 4052
Umesh Lalloo, MD, + 27 31 261 1093/5, lalloo@ecarefoundation.com
Umesh Lalloo, MD
Tanzania4 sites, 4 recruiting
- Not yet recruiting
INUKA Africa
Dar es Salaam
Frederik Haraka, MD, +255 22 270 0021/4, fharaka@inuka-africa.org
Frederik Haraka, MD
- Not yet recruiting
NIMR-Mbeya
Mbeya
Christina Manyama, MD, +255 25 250 3364, christina.manyama@nimr.or.tz
Christina Manyama, MD
- Not yet recruiting
Kilimanjaro Clinical Research Institute(KCRI)
Moshi
Blandina Mmbaga, MD, +255 27 275 4201, b.nmbaga@kcri.ac.tz
Blandina Mmbaga, MD
- Not yet recruiting
NIMRI-Mwanza
Mwanza
Kidola Jeremiah, MD, +255 28 250 3012, kiddola.jeremiah@nimri.or..tz
Kidola Jeremiah, MD
About this study
Official title: A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis
The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200/100SPaL-4/13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis.
Participants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either :
Read more
- a sorfequiline loading-dose regimen (200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks) plus pretomanid 200 mg and linezolid 600 mg daily, or
- sorfequiline 100 mg daily for 17 weeks plus pretomanid 200 mg and linezolid 600 mg daily. Study treatment is administered orally once daily with food.
The primary objective is to assess safety through 17 weeks of treatment, including treatment-emergent adverse events, ECG findings, vital signs, laboratory assessments, visual acuity, and peripheral neuropathy. Secondary objectives include assessments of efficacy (time to stable sputum culture conversion; favorable outcome and treatment failure/relapse at 26 and 52 weeks after end of treatment) and pharmacokinetics of trial drugs, with exploratory analyses including predictors of culture conversion, exposure-response relationships, and quality of life.
Read the detailed description
This is a phase 2, randomised, multi-center, partially blinded, clinical trial conducted in 2 treatment arms.
The trial will be performed at multiple centers in South Africa and Tanzania in at approximately 100 participants with DS-TB who meet all the inclusion criteria and none of the exclusion criteria, aged 18 to 65, inclusive. Participants will be randomised to one of the 2 sorfequiline, pretomanid and linezolid containing regimens and will be randomised in 1:1 ratio based on country and severity of disease (AFB 3+ and/or bilateral cavitation). T
The trial will consist of the following periods:
- Screening period: Screening visit, up to 11 days prior to randomisation (Day 1)
- Treatment Period: approximately 100 participants will be randomised equally to the 2 treatment arms below:
- Sorfequiline 200 mg + pretomanid 200 mg + linezolid 600 mg for 4 weeks followed by sorfequiline 100 mg for 13 weeks
- Sorfequiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 17 week
- Follow-up Period: 52 weeks after end of treatment
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- sorfequiline, Pretomanid, Linezolid
- Keywords
- tuberculosis, sorfequiline, drug sensitive tuberculosis, pretomanid, linezolid
- 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, S
Two sorfequiline 100mg tablets taken once daily for 4 weeks then one sorfequiline taken once daily for 13 weeks OR one sorfequiline 100mg tablet taken once daily for 17 weeks (with one 100mg sorfequiline placebo tablet for the first 4 weeks)
PretomanidDrug
Also called PA-824, P, Dovprela
one 200mg tablet taken once daily for 17 weeks
LinezolidDrug
Also called L, Zyvox, Linospan, Linosept
one 600mg tablet taken once daily for 17 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sorfequline 200/100-Pretomanid 200mg-Linezolid 600mg (Loading Dose) | Experimental | Regimen (17 weeks total):
Weeks 1-4: Sorfequiline 200 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Weeks 5-17: Sorfequiline 100 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Receives: Drug: sorfequiline; Drug: Pretomanid; Drug: Linezolid |
| Sorfequiline 100-Pretomanid 200mg-Linezolid 600mg (No Loading Dose) | Experimental | Regimen (17 weeks total):
Weeks 1-17: Sorfequiline 100 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Includes sorfequiline placebo tablets during first 4weeks to maintain blinding vs the loading regimen. Receives: Drug: sorfequiline; Drug: Pretomanid; Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and characterization of treatment-emergent adverse events (TEAEs)
Includes severity, relationship to study drugs, seriousness, TEAEs leading to discontinuation, and TEAEs leading to death; plus safety monitoring endpoints (ECG, vital signs, clinical labs, visual acuity changes, peripheral neuropathy changes.
Measured: Through 17 weeks of treatment
Secondary outcomes (2)
Time to stable sputum culture conversion (SSCC) to negative
SSCC defined as two negative cultures at least 7 days apart without an intervening MTB-positive result (protocol definition used for time-to-event analyses). Time Frame: Through 17 weeks of treatment
Measured: Through 17 weeks of treatment
Proportion with favorable outcome
Favorable outcome assessed post-treatment; protocol includes evaluation at 26 weeks and 52 weeks after end of treatment
Measured: 26 weeks after EOT; 52 weeks after EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start9 Jul 2026
- Primary completion28 May 2027 (estimated)
- Study completion24 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Alliance for TB Drug Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morounfolu Olugbosi, Study director, TB Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672405
- Sponsor's protocol ID
- NC-010
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- 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 . Finalized results are published following completion of the trial. At that time, requests for the IPD can be made to C-Path at https://c-path.org/tools-platforms/tb-pacts/
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 41495827