Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score. The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.

Key facts

Study ID

NCT03318523

Run by

Biogen

People needed

357

Starts

2018-01-10

Expected to finish

2021-04-29

Last updated by the study team

2022-02-28

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening.
• Score of ≤2.5 on the Modified Hoehn and Yahr Scale.
• Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed. Further guidance will be provided by the study's Medical Monitor on a case by case basis.
• Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reading).
• All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.

You may not qualify if…

• Presence of freezing of gait.
• Montreal cognitive assessment (MOCA) score <23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation.
• History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader.
• History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study.
• Participation in any active immunotherapy study targeting alpha-synuclein.
• Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study.
• Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator.
• Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).
• NOTE : Other protocol defined Inclusion/Exclusion criteria may apply

Where it is running

• St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute — Phoenix, Arizona, United States
• Research Site — La Jolla, California, United States
• Cedars Sinai — Los Angeles, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• Research Site — Stanford, California, United States
• University of Colorado Health — Aurora, Colorado, United States
• Rocky Mountain Movement Disorders Center, PC — Englewood, Colorado, United States
• Parkinson's Disease and Movement Disorders Centerf — Boca Raton, Florida, United States
• Mayo Clinic Hospital — Jacksonville, Florida, United States
• Bioclinica Research — Orlando, Florida, United States
• USF Health Byrd Institute — Tampa, Florida, United States
• Northwestern University PD and Movement Disorders Center — Chicago, Illinois, United States
• Research Site — Chicago, Illinois, United States
• University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States
• Ochsner Health System — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• NYU Langone Health Center — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Durham, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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