NCT02459886

Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease

Completed Phase 1 Last updated 8 August 2019

What this trial tests

Phase 1 trial testing BIIB054 in Parkinson's Disease in 66 participants. Completed in 20 November 2017.

Timeline

1 July 2015

Primary endpoint
20 November 2017

20 November 2017

Quick facts

Lead sponsor	Biogen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	66
Start date	1 July 2015
Primary completion	20 November 2017
Estimated completion	20 November 2017
Sites	9 locations across United States

Drugs / interventions tested

• BIIB054 — full drug profile →
• Placebo

Conditions studied

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

Sponsor

Biogen — full company profile →

Who can join

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

Sponsor's own description

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

Publications & conference data

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

1. Inflammation and immune dysfunction in Parkinson disease.
   Tansey MG, Wallings RL, Houser MC, Herrick MK, et al · · 2022 · cited 895× · PMID 35246670 · DOI 10.1038/s41577-022-00684-6
2. Randomized phase I clinical trial of anti-α-synuclein antibody BIIB054.
   Brys M, Fanning L, Hung S, Ellenbogen A, et al · · 2019 · cited 139× · PMID 31211448 · DOI 10.1002/mds.27738
3. Calcium, mitochondrial dysfunction and slowing the progression of Parkinson's disease.
   Surmeier DJ, Halliday GM, Simuni T. · · 2017 · cited 72× · PMID 28780195 · DOI 10.1016/j.expneurol.2017.08.001
4. 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
5. Emerging Immunotherapies for Parkinson Disease.
   Zella SMA, Metzdorf J, Ciftci E, Ostendorf F, et al · · 2019 · cited 45× · PMID 30539376 · DOI 10.1007/s40120-018-0122-z
6. Neurotrophic factors for disease-modifying treatments of Parkinson's disease: gaps between basic science and clinical studies.
   Chmielarz P, Saarma M. · · 2020 · cited 40× · PMID 32700249 · DOI 10.1007/s43440-020-00120-3
7. Therapeutic approaches in Parkinson's disease and related disorders.
   Valera E, Masliah E. · · 2016 · cited 39× · PMID 26749150 · DOI 10.1111/jnc.13529
8. The Involvement of Neuroinflammation in the Onset and Progression of Parkinson's Disease.
   Jurcau A, Andronie-Cioara FL, Nistor-Cseppento DC, Pascalau N, et al · · 2023 · cited 33× · PMID 37834030 · DOI 10.3390/ijms241914582