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

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ClinicalTrials.gov Identifier: NCT05924243
Recruitment Status : Recruiting
First Posted : June 29, 2023
Last Update Posted : April 15, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: RO7486967 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 22, 2022
Estimated Primary Completion Date : January 30, 2025
Estimated Study Completion Date : January 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RO7486967 Arm
Participants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.
 Drug: RO7486967
For up to approximately 28 days
Placebo Comparator: Placebo
Matching placebo
 Drug: Placebo
For up to approximately 28 days


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with adverse events (AEs) [ Time Frame: Up to 45 Days ]
  2. The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline [ Time Frame: From Baseline to Up to 45 Days ]

Secondary Outcome Measures :
  1. Time to maximum concentration of RO7486967 in Plasma [ Time Frame: Day 1, Day 15, and Day 28 ]
  2. Maximum concentration (Cmax) of RO7486967 in Plasma [ Time Frame: Day 1, Day 15, and Day 28 ]
  3. Area under the curve (AUC) RO7486967 in Plasma [ Time Frame: Day 1, Day 15, and Day 28 ]
  4. Change from baseline in parametric bindings of [18F]-DPA-714 in different brain areas at Day 25 PET [ Time Frame: From Baseline to Approximately Day 25 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05924243


Contacts
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Contact: Reference Study ID Number: BP43176 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05924243    
Other Study ID Numbers: BP43176
First Posted: June 29, 2023    Key Record Dates
Last Update Posted: April 15, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases