Platform Assessing Regimens And Durations In a Global Multisite consortium for TB: A seamless Phase 2B/2C platform trial to evaluate multiple regimens and durations of treatment in pulmonary tuberculosis)
Finding the best treatment combination for TB
What is this study about?
Normally, treatment for tuberculosis (TB) involves people having to take several drugs in combination - usually for 6 months and sometimes much longer. Many people find it difficult to take medication for this length of time.
The PARADIGM4TB (UNITE4TB-01) trial will test multiple new drugs and combinations using a new approach to clinical trials, which aims to improve upon and speed up the way these trials have been done in the past.
This trial will have 2 main stages:
1. In the first stage, the new drug combinations will be compared to the established (first-line) drug combination that has been used for the last 40 years. Each new drug combination will be taken for a period of 4 months and the established treatment combination will be taken for a usual period of 6 months. Each drug combination will be tested in a separate group of 33 people newly diagnosed with TB (the kind of TB that is not resistant to the main drug used in the standard treatment). This initial trial will assess the safety of each of the combinations and how quickly they decrease the number of living TB bacteria found in the sputum (phlegm that people cough up). This is stage is called a 'phase 2B trial'.
2. The drug combinations that look most promising in the 'phase 2B trial' will then advance to the second stage for testing in a new group of 220 people. This stage is called a 'phase 2C trial' and aims to gather more information on the safety of the treatment and on the right length of time the treatment should be taken.
The trial will test many different treatment combinations at the same time in the 2B stage, choosing the best one to go through to the 2C stage. This will allow the trial to rapidly gather information on the performance of new combinations. The 2C stage of the trial aims to find the best treatment duration for a new treatment combination, which can be used in the next and final stage of testing (phase 3) in a very large trial.
The overall aim of the PARADIGM4TB (UNITE4TB-01) trial is to identify one or more combinations and their optimal length of treatment, which can progress to testing in separate, large-scale phase 3 trials.
Type of study
Who is funding the study?
The trial is part of the UNITE4TB Consortium. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute to 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research.
When is it taking place?
The trial opened in 2023 and is expected to run until 2027.
Where is it taking place?
PARADIGM4TB will recruit patients from sites across Africa, Asia, South America and Europe.
Who is included?
Adults with pulmonary tuberculosis.
A new dawn in the fight against tuberculosis
24 Jan 2024