A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

Launched by VENTUS THERAPEUTICS U.S., INC. · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called VENT-02, which is being tested to see if it is safe and effective for patients with mild to moderate Parkinson's disease. The trial will involve about 30 participants who are randomly assigned to receive either the medication or a placebo (a pill that looks the same but has no active ingredients) twice a day for 28 days. The goal is to understand how well the medication works and how it affects the body.

To be eligible for the study, participants must be between 45 and 90 years old, weigh between 100 and 265 pounds, and have been diagnosed with Parkinson's disease for no more than seven years. They should also have specific symptoms of Parkinson's, such as slow movement and at least one other sign like tremors or stiffness. Throughout the trial, participants can expect regular check-ins to monitor their health and any side effects from the medication. This study is currently recruiting, so if you or someone you know fits the criteria, it could be an opportunity to help advance Parkinson's disease research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 45 to 90 years of age, inclusive.
• • Body weight and body mass index (BMI) within the range of 100 to 265 pounds (45 to 120 kg) and 18 to 34 kg/m2 (inclusive), respectively.
• • A diagnosis of idiopathic PD according to United Kingdom (UK) Brain Bank or Movement Disorder Society (MDS) criteria with bradykinesia and ≥ 1 additional cardinal sign of PD (e.g., resting tremor, rigidity).
• • A diagnosis of PD for ≤ 7 years at Screening.
• • A modified Hoehn \& Yahr stage 1 to 2.5.
• • If presently receiving treatment for PD, must be on a stable dose for ≥ 2 weeks prior to dosing, with no expected change in this regimen for the duration of the study.
• • If presently taking any non-PD concomitant medications, must be on a stable dose for ≥ 2 weeks prior to dosing.
• Exclusion Criteria:
• • Any clinically significant abnormality at Screening
• • A positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV) 1/2 at Screening.
• • A significant neurological disease affecting the central nervous system, other than PD, that may affect cognition or ability to complete the study, including but not limited to dementias, severe and repetitive past (up to 5 years) head trauma, normal pressure hydrocephalus, or epilepsy or recurrent seizures (except febrile childhood seizures), as determined by the investigator.
• • Current serious or unstable illnesses, that, in the investigator's opinion, could compromise patient safety and ability to comply with study procedures, or has a life expectancy of \< 24 months.
• • A history of suicidal ideation or previous suicide attempt in the 12 months prior to Screening or is clinically judged by the investigator to be at serious risk for suicide as assessed by medical history, examination, or the C-SSRS.
• • A contraindication (e.g., current use of anticoagulants) that would prohibit a lumbar puncture (LP).
• • Currently enrolled in any other interventional clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study, as assessed by the investigator.
• • Has participated in a clinical trial involving an investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing.
• • Has levodopa-induced dyskinesias lasting for \> 25% of waking day or dyskinesias interfering with many daily activities.
• • Has dysphagia to the extent that it would affect the patient's ability to swallow the investigational medicinal product (IMP).
• • Has a parkinsonian syndrome, including atypical parkinsonism.
• • Is a known carrier (i.e., confirmed by historical medical documentation) of familial PD genes.