A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (PASADENA)

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

19 Mar 2024 → ongoing

Decision date (initial)

2024-03-19

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

2023-504472-24-00

EudraCT number

2017-000087-15

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic, Others

To evaluate the efficacy of RO7046015 versus placebo at Week 52, in participants with early Parkinson’s disease (PD) (H&Y Stages I-II) who are untreated or treated with monoamine oxidase-B (MAO-B) inhibitors since baseline, as measured by change from baseline on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Total Score (sum of Parts I, II and III)

Secondary objectives 4

1. To evaluate the effects of RO7046015 versus placebo at Week 52, in participants with early PD (H&Y Stages I - II) who are untreated or treated with MAO-B inhibitors since baseline on the following: - MDS-UPDRS Parts IA, IB, I- III total and Part III sub scores - Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) change in the ipsilateral (to the clinically-dominant side) putamen - Montreal Cognition Assessment (MoCA) total score - Clinical Global Impression of Improvement (CGI-I)- Patient Global Impression of Change (PGIC) - Schwab and England Activity of Daily Living (SE-ADL) score - Time to worsening in motor or non-motor symptoms - Time to start of dopaminergic PD treatment (levodopa or dopamine agonists) Safety and tolerability of RO7046015.
2. To evaluate the safety and tolerability of treatment with RO7046015 for up to 104 weeks plus the 12-week treatment-free follow-up (Part 2) and up to Part 3 Week 520 (up to ten years) plus the 12-week treatment-free follow-up, with or without concomitant dopaminergic treatment.
3. To evaluate the immunogenicity of RO7046015.
4. To describe pharmacokinetics (PK) of RO7046015 using population PK modelling

Conditions and MedDRA coding

Early Idiopathic Parkinson’s disease (PD)

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. A screening brain DaT-SPECT consistent with PD (central reading)
2. Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline
3. If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks.
4. Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor
5. A diagnosis of PD for 2 years or less at screening
6. Hoehn and Yahr Stage I or II

Exclusion criteria 6

1. A diagnosis of a significant CNS disease other than Parkinson's disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child
2. Mini Mental State Examination (MMSE) </=25
3. History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality
4. Medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia
5. Known carriers of certain familial PD genes (as specified in study protocol)
6. History of PD related freezing episodes or falls

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Change in total MDS-UPDRS score (sum of Parts I, II and III) from baseline at Week 52.

Secondary endpoints 11

1. 1. Change from baseline in MDS-UPDRS Part IA, Part IB, Part I total, Part II total, Part III total and Part III subscores
2. 2. Change from baseline in Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) in ipsilateral (to the clinically dominant side) putamen
3. 3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score
4. 4. Change from baseline in Clinical Global Impression (CGI-I)
5. 5. Change from baseline in Patient Global Impression of change (PGIC)
6. 6. Change from baseline in Schwab and England Activities of Daily Living (SE-ADL)
7. 7. Time to worsening in motor or non-motor symptoms as measured in MDS-UPDRS
8. 8. Time to start of dopaminergic PD treatment (levodopa or dopamine-agonists)
9. 9. Incidence and severity of adverse events (AEs) and serious AEs (SAEs)
10. 10. Incidence of Anti-drug antibodies (ADAs)
11. 11. Population and individual primary PK parameter estimations

Investigational products

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

Test 2

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 8

Locations

4 EU/EEA countries · 26 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 49 files

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

Application history

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