- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04617860
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
January 19, 2022 updated by: Wave Life Sciences Ltd.
A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients With Huntington's Disease
WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2).
To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2145
- Westmead Hospital
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Queensland
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Herston, Queensland, Australia, QLD 4006
- Royal Brisbane & Women's Hospital
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Victoria
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Carlton, Victoria, Australia, 3053
- Royal Melbourne Hospital
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Clayton, Victoria, Australia, 3168
- Monash Health
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Melbourne, Victoria, Australia, 3004
- Alfred Health
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Parkdale, Victoria, Australia, 3195
- Calvary Health Care Bethlehem
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Western Australia
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Perth, Western Australia, Australia, 6910
- North Metropolitan Health Service
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta
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Ontario
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Toronto, Ontario, Canada, M3B 2S7
- Centre for Movement Disorders
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Quebec
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Montreal, Quebec, Canada, H2X019
- Centre Hospitalier de l-Universite de Montreal
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Aarhus, Denmark, 8200
- Aarhus Universitets Hospital
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Odense, Denmark, 5000
- Odense University Hospital and University of Southern Denmark
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Créteil, France, 94010
- Hospital Henri Mondor
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Paris, France, 75646
- Institut du Cerveau et de la Moelle Epinière
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Muenster, Germany, 48149
- George-Huntington-Institut GmbH
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Gdańsk, Poland, 80-462
- Szpital Sw. Wojciecha
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Warsaw, Poland, 02-957
- Instytut Psychiatrii i Neurologii
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Devon
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Exeter, Devon, United Kingdom, EX2 5DW
- Royal Devon and Exeter Hospital NHS Trust
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Glasgow City
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Glasgow, Glasgow City, United Kingdom, G12 0XH
- Queen Elizabeth University Hospital - PPDS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
1. Patient successfully completed the Phase 1b/2a study with WVE-120102, WVE-HDSNP2-001.
Exclusion Criteria:
- Received an investigational drug other than WVE-120102, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer.
- Inability to undergo brain MRI (with or without sedation).
- Clinically significant medical finding on the physical examination other than HD that, in the judgment of the Investigator, will make the patient unsuitable for participation in and/or completion of the study procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: WVE-120102 (Dose A)
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WVE-120102 is a stereopure antisense oligonucleotide.
It is administered monthly via intrathecal injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 to Study Termination (maximum of 12 monthly doses)
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Day 1 to Study Termination (maximum of 12 monthly doses)
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Safety: Number of Patients With a Severe TEAE
Time Frame: Day 1 to Study Termination (maximum of 12 monthly doses)
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Day 1 to Study Termination (maximum of 12 monthly doses)
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Safety: Number of Patients With Serious TEAEs
Time Frame: Day 1 to Study Termination (maximum of 12 monthly doses)
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Day 1 to Study Termination (maximum of 12 monthly doses)
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Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs
Time Frame: Day 1 to Study Termination (maximum of 12 monthly doses)
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Day 1 to Study Termination (maximum of 12 monthly doses)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 24, 2019
Primary Completion (ACTUAL)
April 29, 2021
Study Completion (ACTUAL)
April 29, 2021
Study Registration Dates
First Submitted
October 30, 2020
First Submitted That Met QC Criteria
October 30, 2020
First Posted (ACTUAL)
November 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 9, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Huntington Disease
Other Study ID Numbers
- WVE-HDSNP2-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Huntington Disease
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University of IowaThe University of Texas Health Science Center, Houston; Children's Hospital... and other collaboratorsRecruitingJuvenile Huntington Disease | Juvenile-Onset Huntington DiseaseUnited States
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Sanguine BiosciencesHoffmann-La RocheRecruitingHuntington Disease | Huntington's Dementia | Huntington Disease, Late Onset | Huntington; Dementia (Etiology)United States
-
PrileniaCompletedHealth Volunteers, Huntington DiseaseGermany
-
Assistance Publique - Hôpitaux de ParisCEACompletedBrain Neuroimaging Biomarkers in Huntington DiseaseFrance
-
European Huntington's Disease NetworkCompletedHuntington Disease, JuvenileGermany, United Kingdom
-
Novartis PharmaceuticalsCompletedEarly Manifest Huntington DiseaseCanada, Germany, France, Spain, Hungary
-
University Hospital, AngersCompletedPresymptomatic Huntington DiseaseFrance
-
SOM Innovation Biotech SAActive, not recruitingHuntington ChoreaSpain, Germany, Italy, United Kingdom, France, Poland, Switzerland
-
Neurocrine BiosciencesEnrolling by invitation
-
Neurocrine BiosciencesHuntington Study GroupActive, not recruitingChorea, HuntingtonUnited States, Canada
Clinical Trials on WVE-120102
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Wave Life Sciences Ltd.TerminatedHuntington's DiseaseUnited States, Denmark, Canada, Australia, United Kingdom, France, Germany, Poland
-
Wave Life Sciences Ltd.Active, not recruitingDuchenne Muscular DystrophyJordan, United Kingdom
-
Wave Life Sciences Ltd.TerminatedALS | FTDCanada, Belgium, New Zealand, Netherlands, Australia, Sweden, United Kingdom, Ireland
-
Wave Life Sciences Ltd.RecruitingHuntington DiseaseCanada, Spain, Australia, Denmark, Netherlands, Poland, United Kingdom, France, Germany, Italy
-
Wave Life Sciences Ltd.TerminatedHuntington DiseaseDenmark, Australia, Canada, France, United Kingdom, Germany, Poland
-
Wave Life Sciences Ltd.RecruitingAlpha-1 Antitrypsin DeficiencyUnited Kingdom
-
Wave Life Sciences Ltd.TerminatedALS | FTDNetherlands, United Kingdom
-
Wave Life Sciences Ltd.TerminatedHuntington's DiseaseDenmark, Canada, Australia, United Kingdom, France, Germany, Poland
-
Wave Life Sciences Ltd.CompletedDuchenne Muscular DystrophyBelgium, United Kingdom, France, United States, Italy, Canada, Netherlands
-
Wave Life Sciences Ltd.TerminatedDuchenne Muscular DystrophyUnited States, Belgium, United Kingdom, Czechia, Canada, France, Italy, Sweden