A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.

Last updated: September 16, 2024
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

RO7486967

Placebo

Clinical Study ID

NCT05924243
BP43176
  • Ages 40-85
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: RO7486967
Phase: 1
Study Start date:
September 22, 2022
Estimated Completion Date:
July 18, 2024

Connect with a study center

  • Brain Research Center B.V

    Amsterdam, 1081 GN
    Netherlands

    Site Not Available

  • UMC St Radboud

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Brain Research Center Zwolle

    Zwolle, 8025AZ
    Netherlands

    Site Not Available

  • University of Exeter

    Exeter, EX4 4RN
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust

    London, E1 2ES
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust; Charing Cross Hospital

    London, W6 8RF
    United Kingdom

    Site Not Available

  • National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • St Georges University Hospitals NHS Foundation Trust

    London, SW17 0RE
    United Kingdom

    Site Not Available

  • Campus for Ageing & Vitality; Clincal Ageing Research Unit

    Newcastle, NE4 5PL
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, PL6 8BT
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Advent Health Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • NeuroStudies.net, LLC

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Columbia University Medical Center; The Neurological Institute of New York

    New York, New York 10032
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • University Pennsylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

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