Evaluating ALN-HTT02 for treating Huntington's disease in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of a single dose of ALN-HTT02 in adult patients diagnosed with stage 2 or early stage 3 Huntington's disease. Participants will receive either the investigational drug or a placebo to determine its effects. The study will closely monitor participants for any adverse reactions and measure how the drug is processed in the body. The findings could provide insights into the potential of ALN-HTT02 as a treatment option for Huntington's disease.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Has stage 2 or early Stage 3 Huntington's disease (HD), per the Huntington's Disease Integrated Staging System (HD-ISS)

Exclusion Criteria

* Has significant structural or degenerative neurologic disease other than Huntington's Disease (HD) at screening
* 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 \<60 mL/min/1.73m\^2 at screening
* Has received an investigational agent within the last 1 year or 5 half-lives (if known)

Note: other protocol defined inclusion / exclusion criteria apply

Where it's running

• Clinical Trial Site
  Edmonton, Canada Recruiting
• Clinical Trial Site
  Montreal, Canada Recruiting
• Clinical Trial Site
  Ottawa, Canada Recruiting
• Clinical Trial Site
  Vancouver, Canada Recruiting
• Clinical Trial Site
  Berlin, Germany Recruiting
• Clinical Trial Site
  Bochum, Germany Recruiting

Study contacts

• Study coordinator: Alnylam Clinical Trial Information Line
• Email: clinicaltrials@alnylam.com
• Phone: 1-877-ALNYLAM

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-in-human test of SRP-1005 in Huntington's disease

  This first-in-human study tests SRP-1005 versus placebo in people with Huntington's disease to see if it is safe and tolerable.

  Recruiting at 5 sites Phase 1 Sarepta Therapeutics, Inc. · Westmead, New South Wales and 4 other locations · NCT07536061

• New PET tracer ([11C]CHDI-00491009) to image mutant huntingtin in Huntington disease

  This project will test a new PET tracer ([11C]CHDI-00491009) to see if it binds mutant huntingtin aggregates in adults with Huntington disease and in healthy volunteers.

  Recruiting Early Phase 1 CHDI Foundation, Inc. · Leuven · NCT06634628

• Collecting cerebrospinal fluid to aid in developing treatments for Huntington's disease

  This study is collecting spinal fluid and blood samples from people with Huntington's disease to help find better treatments for the condition.

  Recruiting at 32 sites University College, London · Englewood, Colorado and 39 other locations · NCT02855476

• Global registry for Huntington's Disease

  This study is gathering health information from people with Huntington's disease and their families to help researchers learn more about the disease and find better treatments.

  Recruiting at 160 sites CHDI Foundation, Inc. · Birmingham, Alabama and 182 other locations · NCT01574053

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.