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.

NCT Number	NCT07672405
Lead Sponsor	Global Alliance for TB Drug Development
Conditions	Tuberculosis, Pulmonary
Enrollment	100 participants
Start Date	2026-07-09
Primary Completion	2027-05-28 (estimated)
Study Completion	2028-06-24 (estimated)
Updated on ClinicalTrials.gov	2026-08-13