Parkinson DiseasePhase 1/2NCT06822517
A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease
A Phase 1/2 study testing VENT-02 in people with Parkinson Disease, run by Ventus Therapeutics U.S., Inc. at 23 sites in United States.
Trial summary
This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- VENT-02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 23 sitesUnited States
- Study dates
- 5 Mar 2025to 9 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Investigative Site
Abington, Pennsylvania, 19001
Investigative Site
Aventura, Florida, 33180
Investigative Site
Boca Raton, Florida, 33486
Investigative Site
Coral Gables, Florida, 33134
Investigative Site
Coral Springs, Florida, 33067
Investigative Site
Cutler Bay, Florida, 33189
Investigative Site
Cypress, Texas, 77429
Investigative Site
Daytona Beach, Florida, 32117
Investigative Site
Doral, Florida, 33178
Investigative Site
Englewood, Colorado, 80113
Investigative Site
Farmington Hills, Michigan, 48334
Investigative Site
Fountain Valley, California, 92708
Investigative Site
Jacksonville, Florida, 32256
Investigative Site
Maitland, Florida, 32751
Investigative Site
Memphis, Tennessee, 38157
Investigative Site
Miami, Florida, 33135
Investigative Site
Miami, Florida, 33165
Investigative Site
Round Rock, Texas, 78681
Investigative Site
San Jose, California, 95124
Investigative Site
Scarborough, Maine, 04074
Investigative Site
Spokane, Washington, 99202
Investigative Site
West Hills, California, 91307
Investigative Site
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease
This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease.
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.
- Conditions
- Parkinson Disease
- Being tested
- VENT-02, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENT-02Drug
Orally administered capsules
PlaceboDrug
Orally administered capsules
| Study group | Role | What they receive |
|---|---|---|
| VENT-02 Dose 1 | Experimental | Not described Receives: Drug: VENT-02 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Number of treatment-emergent adverse events (TEAEs) with VENT-02 treatment compared to placebo
Measured: Baseline to Follow-up Visit (Day 35)
Secondary outcomes (2)
Concentrations of biomarkers
Change from baseline in concentrations of biomarkers of inflammation and neurodegeneration in plasma and CSF
Measured: Baseline to Day 28
Concentrations of VENT-02 in plasma and CSF
PK as measured by concentrations of VENT-02 in plasma and CSF
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start5 Mar 2025
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ventus Therapeutics U.S., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822517
- Sponsor's protocol ID
- VENT-02-102
- Status last verified
- Oct 2025
- First submitted
- 6 Feb 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06822517
- Acronym / sponsor ID
- VENT-02-102
- Conditions
- Parkinson Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ventus Therapeutics U.S., Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VENT-02 Dose 1 | Experimental | Drug: VENT-02 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VENT-02Orally administered capsules | Drug | VENT-02 Dose 1 |
| PlaceboOrally administered capsules | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Follow-up Visit (Day 35)
Number of treatment-emergent adverse events (TEAEs) with VENT-02 treatment compared to placebo
2 secondary outcomes
Concentrations of biomarkers
Time frame: Baseline to Day 28
Concentrations of VENT-02 in plasma and CSF
Time frame: Baseline to Day 28
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VENT-02 in people with Parkinson Disease, run by Ventus Therapeutics U.S., Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Baseline to Follow-up Visit (Day 35)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.