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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease

Study acronym: POINT-HD
StatusActive, Not Recruiting
PhasePhase 1
Started2025-11-19
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
Study Status, Study Design, Contacts/Locations v12
Enrollment closed, study ongoing
Final enrollment: 3 participants — 8% of the 40 planned
Enrollment targetestimated 40→confirmed 3
Study sitesdetails revised at 7 of 7 sites
2026-08-27
Study Status, Contacts/Locations v11
Enrollment reopened
Primary completion moved earlier: 2028-02-28 → 2026-12-01
Completion moved earlier: 2029-05-23 → 2026-12-01
Study sitesdetails revised at 7 of 7 sites
2026-07-31
Study Status, Contacts/Locations v10
Enrollment closed, study ongoing
Study sites6→7
2026-06-26
Study Status, Contacts/Locations v9
Study sites4→6
2026-05-29
Study Status, Contacts/Locations, References v8
Primary completion pushed: 2027-12-11 → 2028-02-28
Completion pushed: 2029-03-05 → 2029-05-23
Study sitesdetails revised at 1 of 4 sites
Show 7 earlier versions
2026-05-22
Study Status, Contacts/Locations v7
Study sites3→4
2026-04-24
2 amendments v5-v6
2 re-verifications since 2026-03-27, no change to tracked fields
2026-02-26
Study Status, Contacts/Locations v4
Study sites2→3
2026-01-28
Study Status v3
Re-verified, no change to tracked fields
2025-12-29
Study Status, Contacts/Locations v2
Study sites1→2
2025-12-01
Study Status v1
Re-verified, no change to tracked fields
2025-11-19
Original filing
This is a first-in-human (FIH) study of RG6496 that will assess the safety and tolerability of single-ascending doses of RG6496 administered to huntington's disease gene expansion carriers (HDGECs). The study consists of two parts: Part 1 \[single-ascending dose\] followed by Part 2 \[open-label extension (OLE)\].
Trial Details
NCT Number NCT07246941
Lead Sponsor Hoffmann-La Roche
Conditions Huntington's Disease
Enrollment 3 participants
Start Date 2025-11-19
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-02