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)
Abstract
Introduction: In 2023, tuberculosis (TB) returned to being the world's leading cause of death from a single infectious agent. Current standard of care for drug-sensitive tuberculosis (DS-TB) treatment has a long duration with risk of poor compliance and outcomes and increased risk of development of resistant strains. Sorfequiline (S) is a second-generation diarylquinoline with the potential to contribute both to increased efficacy and improved safety and to a shorter TB treatment regimen for both DS-TB and drug-resistant DR-TB.
Methods and analysis: NC-009 is a phase 2, multicentre, partially blinded, randomized clinical trial conducted in five treatment arms, including three doses of sorfequiline in combination with pretomanid and linezolid for 8 weeks followed by 7 or 18 weeks of HR depending on the participant meeting criteria to stop treatment at week 15. There is also a BPaL arm and standard of care arm, both for a 26-week treatment duration. The study population is smear-positive, DS-TB. The primary objective of the study is to determine the optimal dose of sorfequiline to move forward to a potential phase 3 study based on efficacy and safety data. The study is being conducted in Georgia, South Africa, Tanzania, Uganda, and the Philippines in accordance with ICH-GCP and after approval of all relevant country health authorities and ethics committees.
Discussion: NC-009 is a first in-patient, dose-ranging, phase 2 trial of sorfequiline, with an innovative design…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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