Phase 2a Study of VTX3232 in Parkinson's Disease

NCT06556173 | Completed Phase 2 FDA Drug

• 1 other identifier: VTX3232-203
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to understand if taking VTX3232 is safe in participants diagnosed with early stage idiopathic Parkinson's Disease (PD). Approximately 10 patients will take VTX3232 Dose A. The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 7-day Pre-Baseline Period, a 28-day Open Label Treatment period (a participant receives active Dose A), and a 14-day Follow-Up Period.

Conditions

Idiopathic Parkinson Disease

Keywords

VTX3232; Idiopathic Parkinson's Disease; NLRP3 Inhibitor; Zomagen

Outcome Measures

Primary Outcomes (1)

• Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate and Severity through study completion

  Incidence of AEs and SAEs

  Day 1 of treatment period through study completion, up to 6 weeks

Secondary Outcomes (1)

• Pharmacokinetics (PK) of VTX3232 in plasma and Cerebrospinal Fluid (CSF) at Day 28

  Day 1 of treatment period to Day 28 of treatment period

Study Arms (1)

VTX3232 Dose A

EXPERIMENTAL

Drug: VTX3232

Interventions

VTX3232 DRUG

Dose A

VTX3232 Dose A

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be ≥ 40 years up to 80 years of age, inclusive, at the time of signing the informed consent, with BMI \> 18.5 and \< 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
• Diagnosis of idiopathic Parkinson's Disease between 0 and 60 months prior to screening.
• Score of 2 or less on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV at screening.
• Have not received prior treatment with deep brain stimulation (DBS).
• If receiving treatment with symptomatic PD therapies, treatment must be stable. Note: The Medical Monitor should be contacted with any questions regarding concomitant therapies.
• A female participant is eligible if they are of nonchildbearing potential
• A male participant sexually active with a woman of child bearing potential is eligible if they agree to use contraception/barrier and refrain from donating sperm during the study and for at least 90 days after the last dose

You may not qualify if:

• Diagnosis of a Parkinsonian syndrome other than idiopathic Parkinson's Disease.
• A diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease; history of repeated head injury or traumatic brain injury; history of epilepsy or seizure disorder other than febrile seizures as a child.
• History of brain surgery.

Sponsors & Collaborators

• Zomagen Biosciences Ltd.: lead

Study Sites (1)

Local Site #840001

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Snehal Naik, PhD

  Zomagen Biosciences Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 8, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)