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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7486967
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Georgetown UniversityRecruiting
  • Advent Health OrlandoRecruiting
  • NeuroStudies.net, LLCRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • University Pennsylvania HospitalRecruiting
  • Brain Research Center B.VRecruiting
  • UMC St RadboudRecruiting
  • Brain Research Center ZwolleRecruiting
  • University of ExeterRecruiting
  • Barts Health NHS TrustRecruiting
  • Imperial College Healthcare NHS Trust; Charing Cross HospitalRecruiting
  • National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRFRecruiting
  • Campus for Ageing & Vitality; Clincal Ageing Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RO7486967 Arm

Placebo

Arm Description

Participants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.

Matching placebo

Outcomes

Primary Outcome Measures

Percentage of Participants with adverse events (AEs)
The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline

Secondary Outcome Measures

Time to maximum concentration of RO7486967 in Plasma
Maximum concentration (Cmax) of RO7486967 in Plasma
Area under the curve (AUC) RO7486967 in Plasma
Change from baseline in parametric bindings of [18F]-DPA-714 in different brain areas at Day 25 PET

Full Information

First Posted
June 21, 2023
Last Updated
October 20, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05924243
Brief Title
A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
March 3, 2025 (Anticipated)
Study Completion Date
March 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RO7486967 Arm
Arm Type
Experimental
Arm Description
Participants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
RO7486967
Intervention Description
For up to approximately 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
For up to approximately 28 days
Primary Outcome Measure Information:
Title
Percentage of Participants with adverse events (AEs)
Time Frame
Up to 45 Days
Title
The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline
Time Frame
From Baseline to Up to 45 Days
Secondary Outcome Measure Information:
Title
Time to maximum concentration of RO7486967 in Plasma
Time Frame
Day 1, Day 15, and Day 28
Title
Maximum concentration (Cmax) of RO7486967 in Plasma
Time Frame
Day 1, Day 15, and Day 28
Title
Area under the curve (AUC) RO7486967 in Plasma
Time Frame
Day 1, Day 15, and Day 28
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BP43176 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
NeuroStudies.net, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
University Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Brain Research Center B.V
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC St Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Brain Research Center Zwolle
City
Zwolle
ZIP/Postal Code
8025AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University of Exeter
City
Exeter
ZIP/Postal Code
EX4 4RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Imperial College Healthcare NHS Trust; Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Campus for Ageing & Vitality; Clincal Ageing Research Unit
City
Newcastle
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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).

Learn more about this trial

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

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