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NCT Number: NCT07672405

Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB

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.

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.

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Isango Lethemba TB Research Unit, Port Elizabeth, Bethelsdorp, South Africa

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

sorfequiline

Drug

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)

Other names: TBAJ876, S

Pretomanid

Drug

one 200mg tablet taken once daily for 17 weeks

Other names: PA-824, P, Dovprela

Linezolid

Drug

one 600mg tablet taken once daily for 17 weeks

Other names: L, Zyvox, Linospan, Linosept, Lizolid

Primary outcomes

  1. Incidence and characterization of treatment-emergent adverse events (TEAEs)

    Time frame: Through 17 weeks of treatment

    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.

Secondary outcomes

  1. Time to stable sputum culture conversion (SSCC) to negative

    Time frame: Through 17 weeks of treatment

    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

  2. Proportion with favorable outcome

    Time frame: 26 weeks after EOT; 52 weeks after EOT

    Favorable outcome assessed post-treatment; protocol includes evaluation at 26 weeks and 52 weeks after end of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Leandra Lombard

CONTACT

[email protected]

+27 83 30 76784

Morounfolu Olugbosi, MD

CONTACT

[email protected]

+27 79 045 4917

Sponsors and collaborators

Lead sponsor

Global Alliance for TB Drug Development

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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