A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease
NCT ID: NCT06822517
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
29 participants
INTERVENTIONAL
2025-03-05
2025-10-09
Brief Summary
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The study includes a screening period, a 28-day double-blind treatment period, and a 7-day follow-up period after last dose.
Approximately 30 patients will be randomized into 1 of the 2 treatment arms.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VENT-02 Dose 1
VENT-02
Orally administered capsules
Placebo
Placebo
Orally administered capsules
Interventions
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VENT-02
Orally administered capsules
Placebo
Orally administered capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
90 Years
ALL
No
Sponsors
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Ventus Therapeutics U.S., Inc.
INDUSTRY
Responsible Party
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Locations
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Investigative Site
Fountain Valley, California, United States
Investigative Site
San Jose, California, United States
Investigative Site
West Hills, California, United States
Investigative Site
Englewood, Colorado, United States
Investigative Site
Aventura, Florida, United States
Investigative Site
Boca Raton, Florida, United States
Investigative Site
Coral Gables, Florida, United States
Investigative Site
Coral Springs, Florida, United States
Investigative Site
Cutler Bay, Florida, United States
Investigative Site
Daytona Beach, Florida, United States
Investigative Site
Doral, Florida, United States
Investigative Site
Jacksonville, Florida, United States
Investigative Site
Maitland, Florida, United States
Investigative Site
Miami, Florida, United States
Investigative Site
Miami, Florida, United States
Investigative Site
Winter Park, Florida, United States
Investigative Site
Scarborough, Maine, United States
Investigative Site
Farmington Hills, Michigan, United States
Investigative Site
Abington, Pennsylvania, United States
Investigative Site
Memphis, Tennessee, United States
Investigative Site
Cypress, Texas, United States
Investigative Site
Round Rock, Texas, United States
Investigative Site
Spokane, Washington, United States
Countries
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Other Identifiers
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VENT-02-102
Identifier Type: -
Identifier Source: org_study_id
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