Skip to content

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early-Stage Parkinson’s Disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522683-32-00
Acronym
BN44715
Enrollment
405
Registered
2025-12-23
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-Stage Parkinson’s Disease (PD)

Brief summary

Time to a confirmed motor progression event on MDS‑UPDRS Part III score from the randomization date

Detailed description

Change in motor function from baseline at Week 104, as measured by the MDS-UPDRS Part III off medication score, Time to worsening of participants’ motor function as reported by the participant in the presence of a confirmed motor progression event, Time to meaningful worsening in CGI-C, Overall Disease Subscale, Time to increase in LEDD, 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, Incidence of adverse events of special interest, Incidence of treatment discontinuation due to adverse events, Nature, incidence, seriousness, severity and timing of IRRs, Mean change in vital signs from baseline over time and incidence of abnormal vital sign measurements, Nature and incidence of abnormal ECG assessments, Change from baseline, shift tables, and incidence of laboratory abnormalities (including hematology, clinical chemistry, coagulation, and urinalysis parameters), 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, Serum concentration of prasinezumab or PK parameters at specified timepoints, Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

Interventions

DRUGPlacebo Prasinezumab

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to a confirmed motor progression event on MDS‑UPDRS Part III score from the randomization date

Secondary

MeasureTime frame
Change in motor function from baseline at Week 104, as measured by the MDS-UPDRS Part III off medication score, Time to worsening of participants’ motor function as reported by the participant in the presence of a confirmed motor progression event, Time to meaningful worsening in CGI-C, Overall Disease Subscale, Time to increase in LEDD, 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, Incidence of adverse events of special interest, Incidence of treatment discontinuation due to adverse events, Nature, incidence, seriousness, severity and timing of IRRs, Mean change in vital signs from baseline over time and incidence of abnormal vital sign measurements, Nature and incidence of abnormal ECG assessments, Change from baseline, shift tables, and incidence of laboratory abnormalities (including hematology, clinical chemistry, coagulation, and ur

Countries

Austria, Denmark, France, Germany, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026