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Affiliated study NCT03318523 did not meet its primary outcome measure of change from baseline measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and did not demonstrate efficacy on secondary outcome measures
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: BIIB054 Dose A | Experimental | 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) |
|
| Cohort 2: BIIB054 Dose B | Experimental | 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) |
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| Cohort 3: BIIB054 Dose C | Experimental | 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) |
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| Cohorts 1-3: Placebo | Placebo Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB054 | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 72 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054 | Up to 24 Weeks | |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054 | Up to 24 Weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Toon-shi | Ehime | 791-0295 | Japan | ||
| Research Site |
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| Label | URL |
|---|---|
| Fox Trial Finder | View source |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
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| Placebo | Drug | Administered as specified in the treatment arm. |
|
| Maximum Observed Serum Concentration (Cmax) of BIIB054 | Up to 24 Weeks |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054 | Up to 24 Weeks |
| Terminal Elimination Half-life (t1/2) of BIIB054 | Up to 24 Weeks |
| Clearance (CL) of BIIB054 | Up to 24 Weeks |
| Volume of Distribution at Steady State (Vss) of BIIB054 | Up to 24 Weeks |
| Accumulation Ratio of BIIB054 | Up to 24 Weeks |
| Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054 | Up to 24 Weeks |
| Number of Participants With Anti-BIIB054 Antibodies in Serum | Up to 72 Weeks |
| Asahikawa-shi |
| Hokkaido |
| 070-8644 |
| Japan |
| Research Site | Kyoto | Kyoto | 606-8507 | Japan |
| Research Site | Kyoto | Kyoto | 616-8255 | Japan |
| Research Site | Sendai | Miyagi | 980-8574 | Japan |
| Research Site | Sendai | Miyagi | 982-8555 | Japan |
| Research Site | Suita-shi | Osaka | 565-0871 | Japan |
| Research Site | Bunkyō City | Tokyo-To | 113-8431 | Japan |
| Research Site | Kodaira-shi | Tokyo-To | 187-8551 | Japan |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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