Parkinson's DiseasePhase 1NCT03716570
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease
A Phase 1 study testing BIIB054 in people with Parkinson's Disease, run by Biogen at 9 sites in Japan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- BIIB054
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 9 sitesJapan
- Study dates
- 12 Mar 2019to 23 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with PD within a maximum of 3 years prior to screening.
- Has not received levodopa or any other treatment for PD, herein referred to as symptomatic PD medication (including but, not limited to, dopamine agonists, amantadine, anticholinergics, monoamine oxidase type B (MAO-B) inhibitors, or safinamide) for at least 12 weeks prior to Day 1. Maximum total duration of prior PD regimens should not exceed 30 days.
- Score of less than equal to (<=) 2.5 on the Modified Hoehn and Yahr Scale.
- Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reader).
Who cannot join
- Presence of freezing of gait.
- History of or positive test result at Screening for human immunodeficiency virus (HIV) or hepatitis C virus antibody (anti-HCV).
- Screening value for hemoglobin less than (<)12 gram per deciliter (g/dL) for men or <11 g/dL for women.
- Montreal Cognitive Assessment (MoCA) score <23 or other significant cognitive impairment or clinical dementia.
- History of any brain surgery for PD.
- Participation in any passive or active immunotherapy targeting alpha-synuclein or other PD-related protein.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Research Site
Asahikawa-shi, Hokkaido, 070-8644
Research Site
Bunkyō City, Tokyo-To, 113-8431
Research Site
Kodaira-shi, Tokyo-To, 187-8551
Research Site
Kyoto, Kyoto, 606-8507
Research Site
Kyoto, Kyoto, 616-8255
Research Site
Sendai, Miyagi, 980-8574
Research Site
Sendai, Miyagi, 982-8555
Research Site
Suita-shi, Osaka, 565-0871
Research Site
Toon-shi, Ehime, 791-0295
About this study
Official title: A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease
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.
- Conditions
- Parkinson's Disease
- Being tested
- BIIB054, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB054Drug
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: BIIB054 |
| 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) Receives: Drug: BIIB054 |
| 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) Receives: Drug: BIIB054 |
| 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 Weeks
Secondary outcomes (10)
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054
Measured: Up to 24 Weeks
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054
Measured: Up to 24 Weeks
Maximum Observed Serum Concentration (Cmax) of BIIB054
Measured: Up to 24 Weeks
Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054
Measured: Up to 24 Weeks
Terminal Elimination Half-life (t1/2) of BIIB054
Measured: Up to 24 Weeks
Clearance (CL) of BIIB054
Measured: Up to 24 Weeks
Volume of Distribution at Steady State (Vss) of BIIB054
Measured: Up to 24 Weeks
Accumulation Ratio of BIIB054
Measured: Up to 24 Weeks
Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054
Measured: Up to 24 Weeks
Number of Participants With Anti-BIIB054 Antibodies in Serum
Measured: Up to 72 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start12 Mar 2019
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716570
- Sponsor's protocol ID
- 228PD103
- Status last verified
- May 2021
- First submitted
- 22 Oct 2018
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03716570
- Acronym / sponsor ID
- 228PD103
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: BIIB054 Dose A | Experimental | Drug: BIIB054Participants 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 | Drug: BIIB054Participants will receive IV infusion of BIIB054 Dose B (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks) |
| Cohort 3: BIIB054 Dose C | Experimental | Drug: BIIB054Participants will receive IV infusion of BIIB054 Dose C (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks) |
| Cohorts 1-3: Placebo | Placebo comparator | Drug: PlaceboParticipants 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) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with PD within a maximum of 3 years prior to screening.
- Has not received levodopa or any other treatment for PD, herein referred to as symptomatic PD medication (including but, not limited to, dopamine agonists, amantadine, anticholinergics, monoamine oxidase type B (MAO-B) inhibitors, or safinamide) for at least 12 weeks prior to Day 1. Maximum total duration of prior PD regimens should not exceed 30 days.
- Score of less than equal to (<=) 2.5 on the Modified Hoehn and Yahr Scale.
- Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reader).
Key exclusion criteria (7 listed)
- Presence of freezing of gait.
- History of or positive test result at Screening for human immunodeficiency virus (HIV) or hepatitis C virus antibody (anti-HCV).
- Screening value for hemoglobin less than (<)12 gram per deciliter (g/dL) for men or <11 g/dL for women.
- Montreal Cognitive Assessment (MoCA) score <23 or other significant cognitive impairment or clinical dementia.
- History of any brain surgery for PD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIB054Administered as specified in the treatment arm. | Drug | Cohort 1: BIIB054 Dose A, Cohort 2: BIIB054 Dose B, Cohort 3: BIIB054 Dose C |
| PlaceboAdministered as specified in the treatment arm. | Drug | Cohorts 1-3: Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 72 Weeks
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.
10 secondary outcomes
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
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Fox Trial FinderLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB054 in people with Parkinson's Disease, run by Biogen at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 72 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.