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Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease (PRECISION-HD2)

W

Wave Life Sciences

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Huntington's Disease

Treatments

Drug: Placebo
Drug: WVE-120102

Study type

Interventional

Funder types

Industry

Identifiers

NCT03225846
WVE-HDSNP2-001

Details and patient eligibility

About

PRECISION-HD2 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120102 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362331 (SNP2).

Enrollment

88 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion
  • Ambulatory, male or female patients aged ≥25 - ≤65 years
  • Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
  • Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores ≥7 and ≤13

Key Exclusion Criteria:

  • Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years
  • Received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 halflives of the oligonucleotide, whichever is longer
  • Clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy
  • Inability to undergo brain MRI
  • Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

88 participants in 5 patient groups

WVE-120102 (2 mg) or placebo
Experimental group
Treatment:
Drug: Placebo
Drug: WVE-120102
WVE-120102 (4 mg) or placebo
Experimental group
Treatment:
Drug: Placebo
Drug: WVE-120102
WVE-120102 (8 mg) or placebo
Experimental group
Treatment:
Drug: Placebo
Drug: WVE-120102
WVE-120102 (16 mg) or placebo
Experimental group
Treatment:
Drug: Placebo
Drug: WVE-120102
WVE-120102 (32 mg ) or placebo
Experimental group
Treatment:
Drug: Placebo
Drug: WVE-120102

Trial documents
1

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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