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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05924243
Other study ID # BP43176
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 22, 2022
Est. completion date January 30, 2025

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact Reference Study ID Number: BP43176 https://forpatients.roche.com
Phone 888-662-6728 (U.S. Only)
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date January 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Key Criteria: - Male or post-menopausal female - Diagnosis of clinically probable idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) - A time from diagnosis of PD of at least 3 to maximum 60 months (5 years) at screening - Modified H&Y Stage =2.5 (in ON state) - Dopaminergic imaging consistent with dopamine transporter deficit - "High-affinity binder" or "mixed-affinity binder" genotype for TSPO - Either treatment naïve or treatment with symptomatic PD therapy (levodopa and/or pramipexole, ropinirole, rotigotine) given for at least 90 days, with stable doses for at least 30 days prior to the first dose - No anticipated changes in PD therapy throughout the study duration - SARS-CoV-2 vaccination completed at least 60 days prior to the first dose. Exclusion Key Criteria: - Medical history indicating a Parkinsonian syndrome other than idiopathic PD - CNS or psychiatric disorders other than idiopathic PD (mild depression or anxiety arising in the context of PD is not exclusionary) - History of brain surgery for PD - Use of any of symptomatic drug for PD other than levodopa pramipexole, ropinirole, or rotigotine within 60 days prior to the first dose - Known carriers for mutations in the following genes: alpha-synuclein, LRRK2, GBA, PRKN, PINK1, or DJ1 - Unstable or clinically significant cardiovascular disease within the last year prior to screening - Uncontrolled hypertension - Use of oral anticoagulants, low-molecular-weight heparin, warfarin (Coumadin), acenocoumarol, and phenprocoumon is not allowed within 10 days before the first Lumbar Puncture and during the study (low dose aspirin is permitted as monotherapy) - Concomitant disease or unstable medical condition within 6 months of screening that could interfere with the study or treatment that might interfere with the conduct of the study, including but not limited to autoimmune disease, immunodeficiency diseases, any active infectious disease - History of immunodeficiency diseases - Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HBcAb), or positive hepatitis C (HCV) at screening - Vaccine(s) other than SARS-CoV2 vaccine within 28 days prior to the first dose, or plans to receive vaccines during the study or within 28 days of the last dose - History of chronic liver disease - Clinically significant abnormalities in laboratory test results at screening, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis - Any previous administration of RO7486967 or other compound targeting NLRP3 - Enrollment in another investigational study - Use of any of other investigational therapy (other than protocol-mandated study treatment) within 90 days or 5 drug elimination half-lives (whichever is longer) prior to the first dose

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RO7486967
For up to approximately 28 days
Placebo
For up to approximately 28 days

Locations

Country Name City State
Netherlands Brain Research Center B.V Amsterdam
Netherlands UMC St Radboud Nijmegen
Netherlands Brain Research Center Zwolle Zwolle
United Kingdom University of Exeter Exeter
United Kingdom Barts Health NHS Trust London
United Kingdom Imperial College Healthcare NHS Trust; Charing Cross Hospital London
United Kingdom National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF London
United Kingdom St Georges University Hospitals NHS Foundation Trust London
United Kingdom Campus for Ageing & Vitality; Clincal Ageing Research Unit Newcastle
United Kingdom Derriford Hospital Plymouth
United States University of Alabama at Birmingham Birmingham Alabama
United States NeuroStudies.net, LLC Decatur Georgia
United States CenExel Rocky Mountain Clinical Research, LLC Englewood Colorado
United States Quest Research Institute Farmington Hills Michigan
United States Cedars Sinai Medical Center Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee
United States Columbia University Medical Center; The Neurological Institute of New York New York New York
United States Weill Cornell Medical College New York New York
United States Advent Health Orlando Orlando Florida
United States University Pennsylvania Hospital Philadelphia Pennsylvania
United States The Movement Disorder Clinic of Oklahoma Tulsa Oklahoma
United States Georgetown University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with adverse events (AEs) Up to 45 Days
Primary The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline From Baseline to Up to 45 Days
Secondary Time to maximum concentration of RO7486967 in Plasma Day 1, Day 15, and Day 28
Secondary Maximum concentration (Cmax) of RO7486967 in Plasma Day 1, Day 15, and Day 28
Secondary Area under the curve (AUC) RO7486967 in Plasma Day 1, Day 15, and Day 28
Secondary Change from baseline in parametric bindings of [18F]-DPA-714 in different brain areas at Day 25 PET From Baseline to Approximately Day 25
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