PRASINEZUMAB for Parkinson's disease | Early-stage Parkinson's disease

Inclusion criteria

• {"criterion_text":"- Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria (Postuma et al. 2015) with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism\n- Has received PD medication for at least 3 months prior to baseline\n- An MDS-UPDRS Part IV score of 0 at screening and prior to randomization\n- Hoehn and Yahr (H&Y) Stage 1 or 2 off medication at screening and prior to randomization\n- Agreement to adhere to the contraception requirements"}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required Participants of childbearing potential must have a negative serum pregnancy test result during screening prior to initiation of study treatment\n- Medical history indicating a parkinsonian syndrome other than idiopathic PD\n- Diagnosis of a significant neurological disease other than PD\n- Uncontrolled hypertension"}

Primary endpoints

• {"endpoint_text":"- Time to a confirmed motor progression event on MDS‑UPDRS Part III score from the randomization date","definition_or_measurement_approach":"Measured by MDS‑UPDRS Part III score; time-to-event from randomization to a confirmed motor progression event"}

Secondary endpoints

• {"endpoint_text":"- Change in motor function from baseline at Week 104, as measured by the MDS-UPDRS Part III off medication score","definition_or_measurement_approach":"Change from baseline to Week 104 measured by MDS-UPDRS Part III off medication score"}
• {"endpoint_text":"- Time to worsening of participants’ motor function as reported by the participant in the presence of a confirmed motor progression event","definition_or_measurement_approach":"Participant-reported worsening in presence of a confirmed motor progression event; time-to-event"}
• {"endpoint_text":"- Time to meaningful worsening in CGI-C, Overall Disease Subscale","definition_or_measurement_approach":"Time to meaningful worsening assessed by Clinician Global Impression of Change (CGI-C) Overall Disease Subscale"}
• {"endpoint_text":"- Time to increase in LEDD","definition_or_measurement_approach":"Time-to-event: time until increase in levodopa equivalent daily dose (LEDD)"}
• {"endpoint_text":"- Nature, incidence, seriousness and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0","definition_or_measurement_approach":"Adverse event reporting with severity graded by NCI CTCAE v5.0"}
• {"endpoint_text":"- Incidence of adverse events of special interest","definition_or_measurement_approach":"Incidence counts of pre-specified adverse events of special interest (AESI)"}
• {"endpoint_text":"- Incidence of treatment discontinuation due to adverse events","definition_or_measurement_approach":"Incidence of discontinuations where reason recorded as adverse event"}
• {"endpoint_text":"- Nature, incidence, seriousness, severity and timing of IRRs","definition_or_measurement_approach":"Infusion-related reactions (IRR) characterised by nature, incidence, seriousness, severity and timing"}
• {"endpoint_text":"- Mean change in vital signs from baseline over time and incidence of abnormal vital sign measurements","definition_or_measurement_approach":"Mean change over time and incidence of abnormal vital sign values from scheduled assessments"}
• {"endpoint_text":"- Nature and incidence of abnormal ECG assessments","definition_or_measurement_approach":"Summary and incidence of ECG abnormalities from scheduled ECG assessments"}
• {"endpoint_text":"- Change from baseline, shift tables, and incidence of laboratory abnormalities (including hematology, clinical chemistry, coagulation, and urinalysis parameters)","definition_or_measurement_approach":"Laboratory parameter change from baseline, shift tables and incidence of abnormalities across hematology, chemistry, coagulation and urinalysis"}
• {"endpoint_text":"- Summary statistics of participants with suicidal ideation or behavior as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) score, including detailed focus on any individual cases identified as having severe ideation or behavior during the study conduct","definition_or_measurement_approach":"C-SSRS assessments; summary statistics and case-level focus on severe ideation/behavior"}
• {"endpoint_text":"- Serum concentration of prasinezumab or PK parameters at specified timepoints","definition_or_measurement_approach":"Serum prasinezumab concentration measurements and derived PK parameters at specified timepoints"}
• {"endpoint_text":"- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study","definition_or_measurement_approach":"Assessment of anti-drug antibody (ADA) prevalence at baseline and incidence during study"}

Austria

Earliest CTIS Part Ii Submission Date

03-12-2025

Latest Decision Or Authorization Date

29-12-2025

Processing Time Days

26

Number Of Participants

25

France

Earliest CTIS Part Ii Submission Date

14-11-2025

Latest Decision Or Authorization Date

07-01-2026

Processing Time Days

54

Number Of Participants

60

Italy

Earliest CTIS Part Ii Submission Date

18-11-2025

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

35

Number Of Participants

70

Spain

Earliest CTIS Part Ii Submission Date

20-11-2025

Latest Decision Or Authorization Date

12-01-2026

Processing Time Days

53

Number Of Participants

55

Netherlands

Earliest CTIS Part Ii Submission Date

10-12-2025

Latest Decision Or Authorization Date

12-01-2026

Processing Time Days

33

Number Of Participants

15

Poland

Earliest CTIS Part Ii Submission Date

20-11-2025

Latest Decision Or Authorization Date

04-01-2026

Processing Time Days

45

Number Of Participants

60

Denmark

Earliest CTIS Part Ii Submission Date

09-12-2025

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

14

Number Of Participants

15

Portugal

Earliest CTIS Part Ii Submission Date

25-11-2025

Latest Decision Or Authorization Date

30-12-2025

Processing Time Days

35

Number Of Participants

35

Germany

Earliest CTIS Part Ii Submission Date

12-11-2025

Latest Decision Or Authorization Date

06-01-2026

Processing Time Days

55

Number Of Participants

70

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

IQVIA Limited

Responsibilities

Site management provider

Name

IQVIA Limited

Responsibilities

Central laboratory provider

Name

Neurorx Research Inc.

Responsibilities

Central imaging provider

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Site management provider","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic data capturing (eCRF) provider","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central laboratory provider","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"Central imaging provider","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement provider, Patient services","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Clinical outcome assessment (eCOA, ePRO) provider","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"IxRS provider","organisation_type":"Pharmaceutical company"}