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UNITE4TB’s PARADIGM4TB trial launches Wave 2 recruitment
The UNITE4TB Consortium has announced the start of recruitment for Wave 2 of the PARADIGM4TB trial, marking another important milestone in the effort to accelerate the development of novel tuberculosis (TB) treatment regimens.
Wave 2 introduces a second set of investigational drug regimens into the trial, including additional new chemical entities (NCEs) and novel combinations. This milestone demonstrates the strength of the platform trial design, which enables the parallel assessment of multiple regimens in a streamlined and adaptive way.
The PARADIGM4TB trial is a Phase 2B regimen selection study designed to rapidly identify and advance promising new TB treatments. In July, Wave 1 completed recruitment across trial sites, successfully enrolling patients for the first set of candidate regimens.
“The start of Wave 2 recruitment is an important next milestone in the trial,” said Dr. Ilaria Motta, Principal Clinical Research Fellow at the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL) – sponsors of the PARADIGM4TB trial. “By introducing additional regimens and NCEs, we are taking a crucial step toward identifying the next generation of shorter, safer, and more effective TB treatments.”
With TB remaining one of the world’s leading infectious disease killers, and with drug resistance threatening progress, the need for new treatment options is urgent. By harnessing innovative trial design and broad collaboration across industry, academia, and public partners, UNITE4TB aims to accelerate the path to global TB elimination.
The commencement of Wave 2 recruitment underscores the value of the public-private partnership model driving UNITE4TB, funded by the Innovative Medicines Initiative 2 Joint Undertaking (now the Innovative Health Initiative).
Wave 2 recruitment was initiated at five sites in South Africa. It will continue across 20 sites in up to seven countries globally (South Africa, Uganda, Tanzania, Moldova, Georgia, Brazil, and the Philippines). It is expected that the results will inform the next stage of regimen development.
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