We are pleased to share that the GENERATION HD2 Phase II study investigating tominersen for individuals with early or very subtle symptoms of HD (NCT05686551) has completed recruitment. A few individuals are in the final screening process, but no additional screening openings are available. This information has been shared with study investigators and clinical trial registries will soon be updated to note that the study is active, but no longer recruiting.

The completion of study recruitment is a testament to the partnership and commitment to research of HD organizations like yours and the broader HD community. We deeply thank all participants, family members, and study sites that have supported and continue to support this study.

What happens next?

GENERATION HD2 is designed to follow all participants for at least 16 months, therefore the study is estimated to complete in 2026.

The study has an external, independent data monitoring committee (iDMC) whose purpose is to ensure the safety of participants by regularly reviewing data and the balance of benefit and risk. Between now and the end of the study, the iDMC will continue to review data every 4-6 months and provide recommendations to continue, modify or stop the study. In the last iDMC review a few months ago, the committee recommended continuing the study with no changes.

Additional information about the study can be found on clinical trial registries such as clinicaltrials.gov or ForPatients.Roche.com. Please feel free to let me know if you have any questions.