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Testing VENT-02 for mild to moderate Parkinson's disease

A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

Phase1; Phase2 Interventional Ventus Therapeutics U.S., Inc. · NCT06822517

This study is testing a new drug called VENT-02 to see if it is safe and helps people with mild to moderate Parkinson's disease feel better.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment30 (estimated)
Ages45 Years to 90 Years
SexAll
SponsorVentus Therapeutics U.S., Inc. Industry-sponsored
Locations23 sites (Fountain Valley, California and 22 other locations)
Trial IDNCT06822517 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and tolerability of VENT-02, an NLRP3 inhibitor, in patients with mild to moderate Parkinson's disease. It is a randomized, double-blind, placebo-controlled Phase 1b study where participants will receive either the drug or a placebo twice daily for 28 days. The study includes a screening period, a treatment period, and a follow-up period to assess the drug's pharmacokinetics and pharmacodynamics. Approximately 30 patients will be enrolled and randomized into two treatment arms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 to 90 with mild to moderate idiopathic Parkinson's disease diagnosed within the last 7 years.

Not a fit: Patients with significant health abnormalities or those with advanced stages of Parkinson's disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for managing symptoms of Parkinson's disease.

How similar studies have performed: While this approach is novel, similar studies targeting NLRP3 inhibition have shown promise in other conditions, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fountain Valley, California and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Parkinson Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.