Article

Phase 3b/4 study comparing moxidectin with ivermectin in river blindness is fully enrolled

October 19, 2023

Phase 3b/4 study comparing moxidectin with ivermectin in river blindness is fully enrolled

This project is part of the EDCTP2 programme (Grant RIA2019PD-2880 - MoxiMultiDoseMod) supported by the European Union.

Medicines Development for Global Health has completed enrolment of its Phase 3b/4 study in river blindness comparing the safety and efficacy of annual vs biannual doses of moxidectin or ivermectin (protocol number MDGH-MOX-3001; NCT03876262). This study has enrolled 324 participants, aged at least 12 years old, with confirmed onchocerciasis microfilarial presence in the skin of at least 10 mf/mg or more. It is being conducted in the Democratic Republic of Congo.

The relative benefit of treating for onchocerciasis once or twice per year has been debated for decades. This study will provide definitive data on the optimal ivermectin and moxidectin regimens to inform the onchocerciasis community in their decision-making on treatment frequency during onchocerciasis elimination campaigns. Moxidectin is expected to accelerate elimination of this neglected tropical disease compared to ivermectin.

We are grateful to all members of the investigational team in the Democratic Republic of Congo under the leadership of Principal Investigator Tony Ukety MD, to all participants in this study, and the network of collaborators and funders. This study is supported by The European and Developing Countries Clinical Trials Partnership (grant number RIA2017NCT-1843-MoxiMultiDoseMod) and Luxembourg National Research Fund. The study began in 2021 and is projected to complete in 2026.The website for this study can be found here.

-End

REFERENCES