A Phase 1 interventional study of BIIB054 and Placebo in Parkinson's Disease, sponsored by Biogen. Terminated at 9 sites in Japan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive IV infusion of BIIB054 Dose A (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
Drug: BIIB054
Participants will receive IV infusion of BIIB054 Dose B (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
Drug: BIIB054
Participants will receive IV infusion of BIIB054 Dose C (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
Drug: BIIB054
Participants will receive a single IV infusion of BIIB054 matching placebo (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
Drug: Placebo
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
Time frame: Up to 72 Weeks
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054
Time frame: Up to 24 Weeks
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054
Time frame: Up to 24 Weeks
Maximum Observed Serum Concentration (Cmax) of BIIB054
Time frame: Up to 24 Weeks
Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054
Time frame: Up to 24 Weeks
Terminal Elimination Half-life (t1/2) of BIIB054
Time frame: Up to 24 Weeks
Clearance (CL) of BIIB054
Time frame: Up to 24 Weeks
Volume of Distribution at Steady State (Vss) of BIIB054
Time frame: Up to 24 Weeks
Accumulation Ratio of BIIB054
Time frame: Up to 24 Weeks
Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054
Time frame: Up to 24 Weeks
Number of Participants With Anti-BIIB054 Antibodies in Serum
Time frame: Up to 72 Weeks
Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Data sharing details ↗ · vivli.org
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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