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UNITE4TB’s PARADIGM4TB trial reaches recruitment milestone and advances to innovative treatment duration-selection stage
UNITE4TB’s PARADIGM4TB trial has reached another important milestone with the successful completion of recruitment to the second wave of its regimen-selection stage and has moved to the next stage of the study. This stage aims to identify the optimal treatment duration for the most promising tuberculosis (TB) regimens. This marks a significant step forward in the global search for shorter, safer and more effective treatments for TB.
Since launching in January 2024, the PARADIGM4TB study, sponsored by University College London (UCL), has undertaken one of the most ambitious evaluations of novel TB treatment regimens ever conducted within a multi-arm, multi-stage (MAMS) trial platform. The study has now assessed 13 experimental 16-week regimens alongside control regimens (10 in wave 1 and 3 in wave 2), incorporating three new medicines: ganfeborole (developed by GSK), BTZ-043 (developed by Ludwig Maximilians Universität) and quabodepistat (developed by Otsuka) in combination with established anti-TB medicines.
The innovative design of the PARADIGM4TB study allows multiple treatment regimens to be evaluated simultaneously within a single protocol. This design accelerates decision-making and reduces the time and resources required compared with conducting a separate clinical trial. The platform also provides flexibility to introduce promising new compounds as they become available, ensuring that advances in TB drug development can be assessed rapidly and efficiently.
Following a planned preliminary analysis looking at the efficacy and safety results from the first stage ot the study, the most promising regimens containing either ganfeborole or BTZ-043 will now progress into the next stage of the study. This stage will look at the shortest treatment durations of these regimens to be assessed in future phase 3 trials.
This milestone brings UNITE4TB closer to its goal of accelerating the development of shorter, simpler TB treatment regimens that can improve outcomes for people affected by TB worldwide.
To evaluate different treatment durations, PARADIGM4TB is using a Response Over Continuous Intervention (ROCI) design, developed by researchers at UCL's Institute of Clinical Trials and Methodology (ICTM). The study will test five different treatment durations to identify the optimal treatment duration more precisely than traditional clinical trial approaches.
The next stage will bring the UNITE4TB’s PARADIGM4TB study to more sites across Africa, Asia, South America and Europe. By expanding recruitment worldwide, researchers aim to develop TB treatments that meet the needs of diverse populations and can be used in different healthcare settings.
This milestone reflects the strength of the UNITE4TB partnership and the extraordinary international effort of participants, investigators, communities and partners working together across multiple continents.
About PARADIGM4TB
PARADIGM4TB is sponsored by the UCL Innovative Clinical Trials Unit and is part of UNITE4TB (Academia and Industry United Innovation and Treatment for Tuberculosis), the largest public-private partnership focused on clinical TB drug development in the history of the European Union, with representation from academic institutions, small- and medium-sized enterprises (SMEs), public organizations, and pharmaceutical companies.
Useful links:
PARADIGM4TB Trial website: https://www.innovative-ctu.ucl.ac.uk/studies/all-studies/p/paradigm4tb-unite4tb-01/
ROCI design: https://www.innovative-ctu.ucl.ac.uk/our-research/methodology/design/roci-design/