An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored Studies

Age

25–any

Sex

ALL

Healthy volunteers

Not accepted

Prior enrollment in a Roche-sponsored or Genentech-sponsored study in HD for the RO7234292 (RG6042) development program that made provision for entry into an OLE study
For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
Patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relating to the COVID-19 pandemic
Manifest HD diagnosis, defined as a DCL score of 4
Independence Scale (IS) score \>=70
Genetically confirmed disease by direct DNA testing with a CAP score \>400
Clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (ADLs).

Withdrawal of consent from the preceding study
Permanent discontinuation of RO7234292 (RG6042) for any drug-related safety concern during the preceding study or meeting of any study treatment discontinuation criteria specified in the preceding study at the time of enrollment into this study
An ongoing, unresolved, clinically significant medical problem that in the judgment of the investigator would make it unsafe for the patient to participate in this study
Antiplatelet or anticoagulant therapy within 14 days prior to inclusion or anticipated use during the study, including, but not limited to, aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban, and apixaban
History of bleeding diathesis or coagulopathy
Platelet count less than the lower limit of normal
Concurrent participation in any therapeutic clinical trial
Study treatment (RO7234292/RG6042) is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug
Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug