Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease

Wave Life Sciences

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Huntington Disease

Treatments: Drug: WVE-120102

Study type: Interventional

Funder types: Industry

Identifiers

NCT04617860

WVE-HDSNP2-002

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient successfully completed the Phase 1b/2a study with WVE-120102, WVE-HDSNP2-001.

Exclusion criteria

1. 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.
2. Inability to undergo brain MRI (with or without sedation).
3. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

WVE-120102 (Dose A)

Experimental group

Treatment:

Drug: WVE-120102