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Antisense Oligonucleotide

WVE-003 for Huntington's Disease

Phase 1 & 2
Recruiting
Research Sponsored by Wave Life Sciences Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ambulatory, male or female patients aged ≥25 to ≤60 years
Ambulatory, male or female patients aged ≥25 to ≤60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through end of study (minimum of 36 weeks)
Awards & highlights

Study Summary

This trial is testing a new drug, WVE-003, to see if it is safe and works well in people with early-manifest Huntington's disease who have a certain genetic change.

Who is the study for?
This trial is for adults aged 25-60 with early-manifest Huntington's Disease, who can walk and have certain scores on the UHDRS scale. They must carry a specific genetic marker (SNP3-A variant) linked to their condition. People who've had other experimental drugs recently or have conditions that make lumbar punctures risky can't join.Check my eligibility
What is being tested?
The study tests WVE-003, a potential treatment for Huntington's Disease. Participants are randomly assigned to receive either WVE-003 or a placebo without knowing which one they're getting. The trial will assess safety, how well the body handles the drug (PK), and its effect on disease markers (PD).See study design
What are the potential side effects?
Since this is an early-phase trial for WVE-003, detailed side effects aren't fully known yet. Generally, participants may experience issues related to the administration of the drug via lumbar puncture and possible reactions similar to other oligonucleotides.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 60 years old and can walk on my own.
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I am between 25 and 60 years old and can walk.
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My genetic test shows I have the A variant of SNP3 linked to my condition.
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My genetic test shows I have the A variant of SNP3 linked to my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through end of study (minimum of 36 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through end of study (minimum of 36 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety: Proportion of patients with adverse events (AEs)
Secondary outcome measures
Area under the plasma concentration time curve for WVE-003 from time 0 to last quantifiable concentration (AUC0-t)
Maximum concentration (Cmax) of WVE-003 in plasma
Terminal half-life (t1/2) of WVE-003 in cerebrospinal fluid (CSF)

Trial Design

3Treatment groups
Experimental Treatment
Group I: WVE-003 (Dose C) or placeboExperimental Treatment1 Intervention
Group II: WVE-003 (Dose B) or placeboExperimental Treatment1 Intervention
Group III: WVE-003 (Dose A) or placeboExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Wave Life Sciences Ltd.Lead Sponsor
11 Previous Clinical Trials
424 Total Patients Enrolled
Medical Director, MDStudy DirectorWave Life Sciences
76 Previous Clinical Trials
16,190 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
< 18
18 - 65
What site did they apply to?
Centre Hospitalier de l-Universite de Montreal
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Dec 2024