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Clinical Trials/NCT07174310
NCT07174310RecruitingPhase 3

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

Hoffmann-La Roche192 sites in 10 countries900 target enrollmentStarted: November 24, 2025Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
900
Locations
192
Primary Endpoint
Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Body weight within 40-110 kilograms (kg) (88-242 pounds [lbs]) and a body mass index within the range 18-34 kg/m2
  • •Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
  • •Has received monotherapy treatment
  • •An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
  • •Hoehn and Yahr (H&Y) Stage 1 or 2 off medication at screening and prior to randomization
  • •Agreement to adhere to the contraception requirements

Exclusion Criteria

  • •Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
  • •Medical history indicating a parkinsonian syndrome other than idiopathic PD
  • •Diagnosis of a significant neurologic disease other than PD
  • •Chronic uncontrolled hypertension

Arms & Interventions

Placebo

Experimental

Participants will receive placebo as an IV Infusion.

Intervention: Placebo (Drug)

Prasinezumab

Experimental

Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase.

Intervention: Prasinezumab (Drug)

Outcomes

Primary Outcomes

Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score

Time Frame: Up to at least Week 104

Secondary Outcomes

  • Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale(Up to at least Week 104)
  • Time to increase in Levodopa Equivalent Daily Dose (LEDD)(Up to at least Week 104)
  • Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score(Baseline, Week 104)
  • Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event(Up to at least Week 104)
  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)(From Baseline up to 70 days after the final study dose (up to at least Week 104))
  • Percentage of Participants With Adverse Events of Special Interest (AESI)(From Baseline up to 70 days after the final study dose (up to at least Week 104))
  • Percentage of Participants With Infusion Related Reactions (IRRs)(From Baseline up to 70 days after the final study dose (up to at least Week 104))
  • Percentage of Participants With Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)(From Baseline up to 70 days after the final study dose (up to at least Week 104))
  • Serum Concentration of Prasinezumab(Predose and postdose at Baseline, Week 1, 4, 12, 24, 36, 52, 76, and after week 76 every 12 weeks thereafter until end of study (up to at least Week 104))
  • Percentage of Participants With Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline(At Baseline)
  • Percentage of Participants With ADAs Against Prasinezumab During the Study(From Baseline up to 70 days after the final study dose (up to at least Week 104))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (192)

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