RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Global Alliance for TB Drug Development • ClinicalTrials.gov ID: NCT07672405

Registry updated: 2026-08-19

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Description

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.

Interventions

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)
Pretomanid (Drug)
one 200mg tablet taken once daily for 17 weeks
Linezolid (Drug)
one 600mg tablet taken once daily for 17 weeks

Eligibility criteria

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.

Conditions

Tuberculosis, Pulmonary

Locations

Durban International Clinical Research Site — Wentworth, Durban, South Africa
Isango Lethemba TB Research Unit — Port Elizabeth, Eastern Cape, South Africa
Setshaba Research Centre — Soshanguve, Gauteng, South Africa
University of Capetown Lung Institute — Cape Town, Mowbray, South Africa
The Aurum Institute, Rustenburg — Rustenburg, North West, South Africa
Madiberg Centre for Research — Brits, North West Provinvce, South Africa
Perinatal HIV Research Unit, Tshepong Hospital — Klerksdorp, Northwest Province, South Africa
Synergy Biomed Research Institute — East London, South Africa
INUKA Africa — Dar es Salaam, Tanzania
NIMR-Mbeya — Mbeya, Tanzania
Kilimanjaro Clinical Research Institute(KCRI) — Moshi, Tanzania
NIMRI-Mwanza — Mwanza, Tanzania

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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