NCT05032196CompletedPhase 1/2
Study of WVE-003 in Patients With Huntington's Disease
A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington's Disease (SELECT-HD)
Source: ClinicalTrials.gov · Last updated 12 Aug 2025
Brief summary (registry, in English)
This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of WVE-003 in adult patients with early-manifest HD who carry the targeted single nucleotide polymorphism (SNP) - SNP3.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 18 Aug 2021
- Start date
- 6 Sept 2021
- Primary completion date
- 24 May 2024
- Lead sponsor
- Wave Life Sciences USA, Inc.
- Diseases
- Huntington's disease
- NCT number
- NCT05032196
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 47
- From 6 Sept 2021 to the primary completion date, 24 May 2024
- 23 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years
- Received any other study drug, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer, with the exception of the following:
- Received WVE-120101 or WVE-120102 within the last 3 months
- Implantable CNS device that may interfere with ability to administer study drug via lumbar puncture or undergo MRI scan
- Previously received tominersen
Other illness
- Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
Other
- Inability to undergo brain MRI (with or without sedation)
Who the study is looking for
- Presence of the A variant of SNP3 on the same allele as the pathogenic CAG triplet expansion
- Ambulatory, male or female patients aged ≥25 to ≤60 years
- Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
- UHDRS Total Functional Capacity Scores ≥9 and ≤13
Age in the registry: 25 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| George-Huntington-Institut GmbH Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| kbo-Isar-Amper-Klinikum Taufkirchen (Vils) Coordinator of this site? Confirm its status | Taufkirchen | Germany | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Hospital de la Sanata Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hopital Henri Mondor - Hospital Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Institut Du Cerveau Et De La Moelle Epiniere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Cardiff University, Schools of Medicine and Biosciences Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Royal Devon and Exeter Hospital NHS Trust Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| Royal Hospital for Children, Pharmacy Aseptic Unit Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Royal Liverpool University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Centro Ricerche Cliniche Di Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Szpital Sw. Wojciecha Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Instytut Psychiatrii I Neurologii Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.