Study of WVE-003 in Patients With Huntington’s Disease

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Brief Title

Study of WVE-003 in Patients With Huntington's Disease

Official Title

A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington's Disease

Brief Summary

      This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to
      evaluate the safety, tolerability, PK, and PD of WVE-003 in adult patients with
      early-manifest HD who carry the targeted single nucleotide polymorphism (SNP) - SNP3.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Safety: Proportion of patients with adverse events (AEs)

Secondary Outcome

 Maximum concentration (Cmax) of WVE-003 in plasma

Condition

Huntington Disease

Intervention

WVE-003

Study Arms / Comparison Groups

 WVE-003 (Dose A) or placebo
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

36

Start Date

September 6, 2021

Completion Date

December 2022

Primary Completion Date

December 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Presence of the A variant of SNP3 on the same allele as the pathogenic CAG triplet
             expansion

          2. Ambulatory, male or female patients aged ≥25 to ≤60 years

          3. Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease
             Rating Scale (UHDRS) Diagnostic Confidence Score = 4

          4. UHDRS Total Functional Capacity Scores ≥9 and ≤13

        Exclusion Criteria:

          1. Malignancy or received treatment for malignancy, other than treated basal cell or
             squamous cell carcinoma of the skin, within the previous 5 years

          2. 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:

             a. Received WVE-120101 or WVE-120102 within the last 3 months

          3. Implantable CNS device that may interfere with ability to administer study drug via
             lumbar puncture or undergo MRI scan

          4. Inability to undergo brain MRI (with or without sedation)

          5. Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or
             unsuccessful lumbar puncture
      

Gender

All

Ages

25 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Medical Director, MD, 855-215-4687, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT05032196

Organization ID

WVE-003-001


Responsible Party

Sponsor

Study Sponsor

Wave Life Sciences Ltd.


Study Sponsor

Medical Director, MD, Study Director, Wave Life Sciences


Verification Date

October 2021