NCT03716570 is a Phase 1 clinical trial of BIIB054 in Parkinson's Disease, sponsored by Biogen.

Who is sponsoring NCT03716570?

NCT03716570 is sponsored by Biogen.

What drugs are being tested in NCT03716570?

Interventions in NCT03716570: BIIB054, Placebo.

What condition does NCT03716570 study?

NCT03716570 studies Parkinson's Disease.

Is NCT03716570 still recruiting?

NCT03716570 is currently terminated. Last updated 25 May 2021.

Last reviewed 2021-05-25 · How we verify

NCT03716570

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease

Terminated Phase 1 Last updated 25 May 2021

What this trial tests

Phase 1 trial testing BIIB054 in Parkinson's Disease in 24 participants. Terminated before completion.

Timeline

12 March 2019

Primary endpoint
23 April 2021

23 April 2021

Quick facts

Lead sponsor	Biogen
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	24
Start date	12 March 2019
Primary completion	23 April 2021
Estimated completion	23 April 2021
Sites	9 locations across Japan

Drugs / interventions tested

BIIB054 — full drug profile →
Placebo

Conditions studied

Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

Biogen — full company profile →

Who can join

Adults 40 to 80, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is to evaluate the safety and tolerability of a range of single and 13 repeated doses of BIIB054, administered as intravenous (IV) infusion, in Japanese participants with Parkinson's disease (PD). The secondary objectives are to evaluate the immunogenicity, and serum pharmacokinetics (PK) profile of BIIB054 after single and multiple dose administration.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Novel targeted therapies for Parkinson's disease.
Ntetsika T, Papathoma PE, Markaki I. · · 2021 · cited 78× · PMID 33632120 · DOI 10.1186/s10020-021-00279-2
Therapeutics in the Pipeline Targeting <i>α</i>-Synuclein for Parkinson's Disease.
Grosso Jasutkar H, Oh SE, Mouradian MM. · · 2022 · cited 69× · PMID 35017177 · DOI 10.1124/pharmrev.120.000133
Targeting α-synuclein for PD Therapeutics: A Pursuit on All Fronts.
Teil M, Arotcarena ML, Faggiani E, Laferriere F, et al · · 2020 · cited 53× · PMID 32138193 · DOI 10.3390/biom10030391
Amyloid-β and α-Synuclein Immunotherapy: From Experimental Studies to Clinical Trials.
Nimmo JT, Kelly L, Verma A, Carare RO, et al · · 2021 · cited 31× · PMID 34539340 · DOI 10.3389/fnins.2021.733857
An update on immune-based alpha-synuclein trials in Parkinson's disease.
Alfaidi M, Barker RA, Kuan WL. · · 2024 · cited 29× · PMID 39666171 · DOI 10.1007/s00415-024-12770-x
Alpha-synuclein Immunization Strategies for Synucleinopathies in Clinical Studies: A Biological Perspective.
Knecht L, Folke J, Dodel R, Ross JA, et al · · 2022 · cited 29× · PMID 36083395 · DOI 10.1007/s13311-022-01288-7
Immunotherapies in Huntington's disease and α-Synucleinopathies.
Fatoba O, Ohtake Y, Itokazu T, Yamashita T. · · 2020 · cited 26× · PMID 32161599 · DOI 10.3389/fimmu.2020.00337
Phase II Dose Selection for Alpha Synuclein-Targeting Antibody Cinpanemab (BIIB054) Based on Target Protein Binding Levels in the Brain.
Kuchimanchi M, Monine M, Kandadi Muralidharan K, Woodward C, et al · · 2020 · cited 24× · PMID 32613752 · DOI 10.1002/psp4.12538

Verify or expand the search:

Other trials of BIIB054

Trials testing the same drug.

NCT03318523 — Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Dise · Phase 2 · terminated
NCT02459886 — Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease · Phase 1 · completed

Other recruiting trials for Parkinson's Disease

Currently open trials in the same condition.

NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
NCT07330258 — A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite · recruiting
NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07384442 — Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's · NA · recruiting
NCT06562569 — Non-invasive VNS for PD Gait · NA · recruiting

Other Biogen trials

Trials by the same sponsor.

NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03716570 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 25 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03716570.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing