Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
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
1 other identifier
interventional
100
2 countries
11
Brief 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. Participants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either :
- 1.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
- 2.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2026
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedStudy Start
First participant enrolled
July 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 24, 2028
July 15, 2026
July 1, 2026
11 months
June 15, 2026
July 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Through 17 weeks of treatment
Secondary Outcomes (2)
Time to stable sputum culture conversion (SSCC) to negative
Through 17 weeks of treatment
Proportion with favorable outcome
26 weeks after EOT; 52 weeks after EOT
Study Arms (2)
Sorfequline 200/100-Pretomanid 200mg-Linezolid 600mg (Loading Dose)
EXPERIMENTALRegimen (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
Sorfequiline 100-Pretomanid 200mg-Linezolid 600mg (No Loading Dose)
EXPERIMENTALRegimen (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.
Interventions
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)
one 200mg tablet taken once daily for 17 weeks
one 600mg tablet taken once daily for 17 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Isango Lethemba TB Research Unit
Port Elizabeth, Bethelsdorp, 6200, South Africa
Setshaba Research Centre
Pretoria, Guateng, 0152, South Africa
University of Capetown Lung Institute
Cape Town, Mowbray, 7700, South Africa
The Aurum Institute, Rustenburg
Rustenburg, North West, 2999, South Africa
Madiberg Centre for Research
Brits, North West Provinvce, 0250, South Africa
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, Wentworth, 4052, South Africa
Synergy Biomed Research Institute
East London, 5201, South Africa
INUKA Africa
Dar es Salaam, Tanzania
Mbeya Referral Hospital
Mbeya, Tanzania
Kilimanjaro Clinical Research Instuute
Moshi, Tanzania
National Instittute for Medical Research
Mwanza, Tanzania
Related Publications (1)
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.
PMID: 41495827BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Morounfolu Olugbosi
TB Alliance
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2026
First Posted
June 26, 2026
Study Start
July 9, 2026
Primary Completion (Estimated)
May 28, 2027
Study Completion (Estimated)
June 24, 2028
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- IPD will be available post trial completion
- Access Criteria
- Researchers will be able to access the IPD (datasets) and supporting information through C-path URL.
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/