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

Recruiting in Palo Alto (17 mi)

+41 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial will test the long-term safety of a drug called RO7234292 (RG6042) in people who have already participated in earlier studies for Huntington's disease. The drug is given through an injection into the spinal fluid periodically. The goal is to see if the drug remains safe and tolerable over a longer period. RO7234292 (RG6042) is being tested for its ability to target and reduce the production of the huntingtin protein, which is implicated in Huntington's disease.

Eligibility Criteria

Inclusion Criteria

The text suggests that the individual should have functional independence in order to maintain self-care and core activities of daily living.

during the course of the trial and for three months after the last dose of the study medication Ladies who could potentially become pregnant must agree to not have sex or use contraception during the trial and for three months after the last dose of the study drug.

will have the opportunity to enroll in an open-label extension study Patients who were screened and eligible for the Phase III study BN40423 but could not be randomized prior to the close of enrollment due to challenges relating to the COVID-19 pandemic will have the opportunity to enroll in an open-label extension study.

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Treatment Details

Interventions

RO7234292 (RG6042) (Antisense Oligonucleotide)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: RO7234292 (RG6042) Q8WExperimental Treatment1 Intervention

Participants who received open-label RO7234292 Q4W in a preceding study or who received RO7234292 Q4W in this study may be randomly allocated to receive RO7234292 Q8W. Participants who previously received open-label of RO7234292 Q8W in a preceding study or are currently receiving RO7234292 Q8W in this study will receive RO7234292 Q8W. Participants who previously received placebo, or did not previously receive treatment with RO7234292 or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 Q8W. Participants who previously received blinded placebo Q8W may receive RO7234292 Q8W. Participants who received blinded RO7234292 Q8W will receive open-label RO7234929 Q8W. Participants who received blinded placebo Q8W may receive RO7234292 Q8W. Participants who received blinded RO7234292 Q4W or blinded placebo Q4W may be randomly allocated to receive open-label of RO7234292 Q8W.

Group II: RO7234292 (RG6042) Q16WExperimental Treatment1 Intervention

Participants who previously received open-label RO7234292 Q4W in a preceding study or who received RO7234292 Q4W in this study may be randomly allocated to receive RO7234292 Q16W. Participants who previously received placebo in a preceding study or did not previously receive treatment with RO7234292 or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 Q16W. Participants who previously received blinded placebo Q8W will receive RO7234292 Q8W. Participants who previously received blinded RO7234292 Q16W will receive open-label RO7234292 Q16W. Participants who received blinded RO7234292 Q4W or blinded placebo Q4W may be randomly allocated to receive open-label of RO7234292 Q16W. Participants who previously received open-label RO7234292 Q16W will receive open-label RO7234292 Q16W.