PanACEA has a strong history of well conducted clinical trials to evaluate new regimens for the treatment of drug sensitive TB. Our studies range from small two-center early Phase IIA studies through to large-scale Phase III studies in a multitude of sites and countries. At the start of the consortium, separate development programmes were conducted for each of the drugs in our portfolio (at the time moxifloxacin, rifampicin and SQ109). These programmes have since come together with a particular emphasis on regimen development and, introducing the Multi-Arm Multi-Stage (MAMS) study design, has set a new standard in TB combination therapy research, investigating all three drugs in different regimes in one trial. We continue to employ innovative methodology and biomarkers to design more efficient trials and speed the development of new regimens.
| Acronym | Study Chair | ClinicalTrials.gov Identifier | First Patient Recruited | Total Patients | Drugs/Regimens Studied | Trial Design |
|---|---|---|---|---|---|---|
| REMox | Stephen Gillespie | NCT00864383 | 18 January 2008 | 1931 patients | Rapid Evaluation of Moxifloxacin in Tuberculosis in cooperation with GTBA | Phase III |
| HR1 | Martin Boeree Rob Aarnoutse | NCT01392911 | 09 June 2011 | 81 patients | Rapid Evaluation of High-Dose Rifampicin and other Rifamycins in Tuberculosis | Phase IIA |
| HR2 | Rob Aarnoutse Martin Boeree | NCT00760149 | 13 August 2010 | 150 patients | Rapid Evaluation of High-Dose Rifampicin and other Rifamycins in Tuberculosis | Phase IIB |
| SQ109 EBA | Michael Hölscher | NCT01218217 | 2010 | 90 patients | Evaluation of a Novel TB Drug (SQ109) to Shorten and Simplify Tuberculosis Treatment | Phase IIA |
| MAMS-TB | Martin Boeree Michael Hölscher | NCT01785186 | 07 May 2013 | 365 patients | A multiple arm, multiple stage (MAMS) trial to evaluate four treatment regimens including SQ109, two increased doses of rifampicin and moxifloxacin | Phase IIB |
| BTZ-043-02 | Michael Hölscher Patrick Philips | NCT04044001 | 15 November 2019 | 77 patients | Evaluation of the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of Multiple Oral Doses of BTZ-043 Tablets in Subjects With Newly Diagnosed, Uncomplicated, Smear-positive, Drug-susceptible Pulmonary Tuberculosis | Phase IB/IIA |
| PHENORIF | Rob Aarnoutse | - | - | 25 patients | The Effect of High Dose Rifampicin on the Activity of Cytochrome P450 Enzymes and P-glycoprotein in Subjects With Pulmonary Tuberculosis: a Cocktail Phenotyping Study | Drug-drug interaction study |
| SUDOCU | Norbert Heinrich | NCT03959566 | - | 75 patients | Open-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure- Response Relationship of different doses of Sutezolid in combination with Bedaquiline, Delamanid and Moxifloxacin in Adult Subjects with Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis | Phase IIB |
| DECODE | Norbert Heinrich | NCT04550832 | February 2022 | 75 patients | Delpazolid dose-finding and combination development | Phase II |
| STEP2C | Michael Hölscher Martin Boeree | NCT05807399 | April 2023 | 270 patients | A multiple arm, multiple stage (MAMS), phase 2B/C, open label, randomized, controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin and BTZ043, in adults with newly diagnosed, drug sensitive, smear-positive pulmonary tuberculosis | Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP) trial design |
For more information on our studies, please search here: http://clinicaltrials.gov