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

  • Neurodegenerative Disorder
  • Parkinson's Disease (PD)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Cities
  • Amsterdam
  • Birmingham
  • Denver
  • Exeter
  • Farmington Hills
  • London
  • Los Angeles
  • New York
  • Newcastle upon Tyne
  • Nijmegen
  • Orlando
  • Philadelphia
  • Tulsa
  • Washington
  • Zwolle
Trial Identifier:

NCT05924243 BP43176

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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).

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT05924243,BP43176 Trial Identifier
      RO7486967, Placebo Treatments
      Parkinson Disease Condition
      Official Title

      A Phase 1b, Adaptive, Multi-Center, Randomized, Double Blind, Placebo-Controlled, Parallel Design Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease

      Eligibility Criteria

      All Gender
      ≥40 Years & ≤ 85 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      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 Criteria

      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

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