A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
NCT ID: NCT06585449
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
54 participants
INTERVENTIONAL
2024-10-14
2028-07-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ALN-HTT02
Participants will be administered a single dose of ALN-HTT02 during the Double-blind Part of the study. Participants who received ALN-HTT02 in the Double-blind part of the study will not receive an additional dose during the Open-label part of the study
ALN-HTT02
ALN-HTT02 will be administered intrathecally
Placebo + ALN-HTT02
Participants will be administered a single dose of placebo during the Double-blind Part of the study. Participants will have the option to receive a single dose of ALN-HTT02 during the Open-Label Part of the study.
ALN-HTT02
ALN-HTT02 will be administered intrathecally
Placebo
Placebo will be administered intrathecally
Interventions
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ALN-HTT02
ALN-HTT02 will be administered intrathecally
Placebo
Placebo will be administered intrathecally
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has primary or secondary immune compromise at screening due to infections, medical conditions, or chronic therapies
* Has alanine aminotransferase or aspartate aminotransferase \>2× upper limit of normal (ULN)
* Has an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m\^2 at screening
* Has received an investigational agent within the last 1 year or 5 half-lives (if known)
25 Years
70 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Edmonton, , Canada
Clinical Trial Site
Montreal, , Canada
Clinical Trial Site
Ottowa, , Canada
Clinical Trial Site
Vancouver, , Canada
Clinical Trial Site
Bayern, , Germany
Clinical Trial Site
Berlin, , Germany
Clinical Trial Site
Bochum, , Germany
Clinical Trial Site
Bonn, , Germany
Clinical Trial Site
Dresden, , Germany
Clinical Trial Site
Ulm, , Germany
Clinical Trial Site
Venusberg, , Germany
Clinical Trial Site
Birmingham, , United Kingdom
Clinical Trial Site
Cambridge, , United Kingdom
Clinical Trial Site
Cardiff, , United Kingdom
Clinical Trial Site
Glasgow, , United Kingdom
Clinical Trial Site
London, , United Kingdom
Clinical Trial Site
Manchester, , United Kingdom
Clinical Trial Site
Oxford, , United Kingdom
Clinical Trial Site
Plymouth, , United Kingdom
Countries
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Central Contacts
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Alnylam Clinical Trial Information Line
Role: CONTACT
Phone: 1-877-256-9526
Email: [email protected]
Other Identifiers
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ALN-HTT02-001
Identifier Type: -
Identifier Source: org_study_id