A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

11 May 2021 → ongoing

Decision date (initial)

2024-07-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2023-507132-21-00

EudraCT number

2020-004997-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Safety, Efficacy

To evaluate the efficacy of prasinezumab compared with placebo on basis of
time to confirmed motor progression event
The main objective for the OLE period of the study is to evaluate long-term safety and tolerability of prasinezumab in patients with early PD that have completed the double‑blind treatment period of the PADOVA

Secondary objectives 4

1. To evaluate the efficacy of prasinezumab compared with placebo on basis of time-to-worsening of patient’s motor function as reported by the patient in the presence of a confirmed motor progression event, time to meaningful worsening in the overall disease as reported by the patient and by the clinician, change from baseline in motor function, change from baseline in bradykinesia and rigidity, time to onset of motor complications
2. To evaluate the safety of prasinezumab compared with placebo
3. To characterize the prasinezumab pharmacokinetic (PK) profile
4. To evaluate the immune response to prasinezumab

Conditions and MedDRA coding

Early Parkinson's disease

Study design 5 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Diagnosis of idiopathic Parkinson's disease (PD) based on Movement disorder society (MDS) criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
2. On symptomatic PD medication with stable doses for at least 3 months prior to baseline
3. A diagnosis of PD for at least 3 months to maximum 3 years at screening
4. Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization
5. Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization
6. Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader

Exclusion criteria 5

1. Medical history indicating a Parkinsonian syndrome other than idiopathic PD
2. Diagnosis of PD dementia
3. Diagnosis of a significant neurologic disease other than PD
4. Within the last year, unstable or clinically significant cardiovascular disease
5. Uncontrolled hypertension

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Time to confirmed motor progression event

Secondary endpoints 21

1. 1. Time-to-worsening of patient’s motor function as reported by the patient in MDS-UPDRS Part II and in the presence of a confirmed motor progression event
2. 2. Time to meaningful worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale)
3. 3. Time to meaningful worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale)
4. 4. Change in motor function from baseline to Week 76, as measured by the MDS-UPDRS Part III score
5. 5. Change in bradykinesia and rigidity from baseline to Week 76, as measured by the MDS-UPDRS Part III bradykinesia and rigidity subscore
6. 6. Time to onset of motor complications as assessed through MDS-UPDRS Part IV
7. 7. Nature, Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
8. 8. Incidence of adverse events of special interest
9. 9. Incidence of treatment discontinuation due to adverse events
10. 10. Nature, Incidence, seriousness and severity of infusion-related reactions (IRRs)
11. 11. Change from baseline in vital signs
12. 12. Incidence of abnormal vital sign measurements
13. 13. Change from baseline in electrocardiogram (ECG) assessments
14. 14. Incidence of abnormal ECG assessments
15. 15. Change from baseline in laboratory measurements
16. 16. Incidence of abnormal laboratory measurements
17. 17. Incidence of physical and neurologic examination abnormalities
18. 18. Change from baseline in suicidal ideation, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
19. 19. Serum concentration of prasinezumab at specified timepoints
20. 20. Prevalence of anti-drug antibodies (ADAs) against prasinezumab at baseline
21. 21. Incidence of ADAs against prasinezumab during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 7

Locations

6 EU/EEA countries · 68 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 66 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications