UNITE4TB, the largest public-private collaboration in tuberculosis drug development, announces start of clinical trials, including the UCSF-designed PARADIGM4TB adaptive clinical trial

Today, UNITE4TB, an international public-private partnership striving to fast-track the development of innovative Tuberculosis (TB) treatments, announced the start of its Phase 2B/C clinical trial program with the first participant enrolled at its trial site in Cape Town, South Africa. The announcement is a major milestone for the project and the TB community as a whole, helping to advance TB science and enhance the efficiency with which new treatments are delivered. 

The UNITE4TB trial program includes PARADIGM4TB, a phase 2B/C platform trial to evaluate multiple regimens and durations of treatment in Pulmonary Tuberculosis. PARADIGM4TB will establish which fourth drug (either moxifloxacin, linezolid, or pyrazinamide) can be added as the optimal component to a bedaquiline, delamanid, BTZ-043 or GSK656 regimen. 

The phase 2B component of this platform trial has been developed by UCSF, and more details can be seen at this paper which is currently in press:

A Flexible Multi-Metric Bayesian Framework for Decision-Making in Phase II Multi-Arm Multi-Stage Studies. Suzanne M. Dufault, Angela M. Crook, Katie Rolfe, Patrick P.J. Phillips. Statistics in Medicine 2023 [in press] arXiv:2302.07290 

Link to full press release