Supranuclear Palsy, ProgressivePhase 1NCT02658916
Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003
A Phase 1 study testing BIIB092 in people with Supranuclear Palsy, Progressive, run by Biogen at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) infusions of BIIB092 in participants with Progressive Supranuclear Palsy (PSP). Read more about this study
- Who is it for?
- Ages 41 to 86 years
- Conditions the study is for
- Supranuclear Palsy, Progressive
- What is being tested?
- BIIB092
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 13 sitesUnited States
- Study dates
- 22 Feb 2016to 31 Mar 2020
- 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 41 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed treatment in Study CN002003.
- A diagnosis of probable or possible PSP consistent with Study CN002003 criteria with no new medical information or diagnoses since enrollment into Study CN002003 that might confer doubt on the PSP diagnosis.
- Able to tolerate Magnetic Resonance Imaging (MRI).
- Able to perform all protocol-specified assessments and comply with the study visit schedule.
- Have reliable caregiver to accompany patient to all study visits. Caregiver must be able to read, understand, and speak local language fluently to ensure comprehension of informed consent and informant-based assessments of patient. Caregiver must also have frequent contact with patient (at least 3 hours per week at one time or at different times) and be willing to monitor the patient's health and concomitant medications throughout the study.
- Patient must reside outside a skilled nursing facility or dementia care facility at the time of enrollment
- Women of childbearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use highly effective birth control.
Who cannot join
- Presence of an unstable, clinically significant medical condition other than PSP including, but not limited to: hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, immunological, psychological or neurological disease or malignancy.
- Contraindication to undergoing a lumbar puncture (LP).
- Recent drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition).
- Treatment with any investigational drugs (including placebo) other than BIIB092 or placebo given in Study CN002003 or devices within 90 days prior to enrollment
- Any vaccination within 30 days prior to study drug administration.
- Contraindication to the MRI examination for any reason
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- Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- Known history of human immunodeficiency virus.
- Evidence of organ dysfunction or significant deterioration from prior values in CN002003 beyond what is consistent with the target population or that would place the patient at increased risk or risk of early study discontinuation.
- Inability to be venipunctured and/or tolerate venous access.
- History of allergy, hypersensitivity, or serious adverse reaction to monoclonal antibodies or related compounds or allergy to any of the components of the study drug
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
Boca Raton, Florida, 33486
The University of Chicago Medical Center
Chicago, Illinois, 60637
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8830
University of Florida College of Medicine
Gainesville, Florida, 32607
University of California San Diego
La Jolla, California, 92037
David Geffen School of Medicine at UCLA
Los Angeles, California, 90024
University of Minnesota Medical School
Minneapolis, Minnesota, 55455-0341
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901-1962
Columbia University Medical Center
New York, New York, 10032
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4206
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, 94158
University of South Florida
Tampa, Florida, 33612
About this study
Official title: A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003
The purpose of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) infusions of BIIB092 in participants with Progressive Supranuclear Palsy (PSP). The study will also assess the pharmacodynamic (PD) effects of BIIB092 on cerebrospinal fluid (CSF) N-terminal tau, pharmacokinetics (PK), and immunogenicity of BIIB092 in participants with PSP.
Read the detailed description
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
- Conditions
- Supranuclear Palsy, Progressive
- Being tested
- BIIB092
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB092Drug
Also called BMS-986168
Same dose as corresponding CN002003 study panel.
| Study group | Role | What they receive |
|---|---|---|
| Panel 1: BIIB092 | Experimental | BIIB092 administered by intravenous (IV) infusion, once every four weeks. Receives: Drug: BIIB092 |
| Panel 2: BIIB092 | Experimental | BIIB092 administered by intravenous (IV) infusion, once every four weeks. Receives: Drug: BIIB092 |
| Panel 3: BIIB092 | Experimental | BIIB092 administered by intravenous (IV) infusion, once every four weeks. Receives: Drug: BIIB092 |
| Panel 4: BIIB092 (Expansion Panel) | Experimental | BIIB092 administered by intravenous (IV) infusion, once every four weeks. Receives: Drug: BIIB092 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths
Measured: Day 1 through study completion (approximately 1.5 years or later)
Percentage of Participants with Marked Abnormalities in Clinical Laboratory Tests, Vital sign Measurements, ECGs, and Physical and Neurological Examinations
Measured: Day 1 through study completion (approximately 1.5 years or later)
Secondary outcomes (4)
Serum Trough Concentration (C-trough) of BIIB092
Measured: Up to study completion (approximately 1.5 years or later)
End-of-Infusion Serum Concentration of BIIB092
Measured: Day 1 through study completion (approximately 1.5 years or later)
Number of Participants with drug antibodies (anti-BIIB092) in Serum
Measured: Up to study completion (approximately 1.5 years or later)
Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48
Measured: Baseline, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start22 Feb 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: 251PP301(NCT03068468) primary endpoint was not met;further development of Gosuranemab BIIB092 in progressive supranuclear palsy will not be pursued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supranuclear Palsy, ProgressiveStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 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
- NCT02658916
- Sponsor's protocol ID
- 251PP201
- Other IDs
- CN002-004
- Status last verified
- May 2020
- First submitted
- 13 Jan 2016
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003
- ClinicalTrials.gov ID
- NCT02658916
- Acronym / sponsor ID
- 251PP201
- Conditions
- Supranuclear Palsy, Progressive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 251PP301(NCT03068468) primary endpoint was not met;further development of Gosuranemab BIIB092 in progressive supranuclear palsy will not be pursued.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 20 Jan 2016 (estimated)
- 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 purpose of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) infusions of BIIB092 in participants with Progressive Supranuclear Palsy (PSP). The study will also assess the pharmacodynamic (PD) effects of BIIB092 on cerebrospinal fluid (CSF) N-terminal tau, pharmacokinetics (PK), and immunogenicity of BIIB092 in participants with PSP.
Detailed description
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panel 1: BIIB092 | Experimental | Drug: BIIB092BIIB092 administered by intravenous (IV) infusion, once every four weeks. |
| Panel 2: BIIB092 | Experimental | Drug: BIIB092BIIB092 administered by intravenous (IV) infusion, once every four weeks. |
| Panel 3: BIIB092 | Experimental | Drug: BIIB092BIIB092 administered by intravenous (IV) infusion, once every four weeks. |
| Panel 4: BIIB092 (Expansion Panel) | Experimental | Drug: BIIB092BIIB092 administered by intravenous (IV) infusion, once every four weeks. |
Who may qualify
- Ages
- 41 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Completed treatment in Study CN002003.
- A diagnosis of probable or possible PSP consistent with Study CN002003 criteria with no new medical information or diagnoses since enrollment into Study CN002003 that might confer doubt on the PSP diagnosis.
- Able to tolerate Magnetic Resonance Imaging (MRI).
- Able to perform all protocol-specified assessments and comply with the study visit schedule.
- Have reliable caregiver to accompany patient to all study visits. Caregiver must be able to read, understand, and speak local language fluently to ensure comprehension of informed consent and informant-based assessments of patient. Caregiver must also have frequent contact with patient (at least 3 hours per week at one time or at different times) and be willing to monitor the patient's health and concomitant medications throughout the study.
Key exclusion criteria (12 listed)
- Presence of an unstable, clinically significant medical condition other than PSP including, but not limited to: hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, immunological, psychological or neurological disease or malignancy.
- Contraindication to undergoing a lumbar puncture (LP).
- Recent drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition).
- Treatment with any investigational drugs (including placebo) other than BIIB092 or placebo given in Study CN002003 or devices within 90 days prior to enrollment
- Any vaccination within 30 days prior to study drug administration.
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 |
|---|---|---|
| BIIB092Also: BMS-986168Same dose as corresponding CN002003 study panel. | Drug | Panel 1: BIIB092, Panel 2: BIIB092, Panel 3: BIIB092, Panel 4: BIIB092 (Expansion Panel) |
Primary outcome
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths
Time frame: Day 1 through study completion (approximately 1.5 years or later)
Percentage of Participants with Marked Abnormalities in Clinical Laboratory Tests, Vital sign Measurements, ECGs, and Physical and Neurological Examinations
Time frame: Day 1 through study completion (approximately 1.5 years or later)
4 secondary outcomes
Serum Trough Concentration (C-trough) of BIIB092
Time frame: Up to study completion (approximately 1.5 years or later)
End-of-Infusion Serum Concentration of BIIB092
Time frame: Day 1 through study completion (approximately 1.5 years or later)
Number of Participants with drug antibodies (anti-BIIB092) in Serum
Time frame: Up to study completion (approximately 1.5 years or later)
Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48
Time frame: Baseline, Week 48
Results and safety
The study was stopped early (reason given: 251PP301(NCT03068468) primary endpoint was not met;further development of Gosuranemab BIIB092 in progressive supranuclear palsy will not be pursued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
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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
13 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 BIIB092 in people with Supranuclear Palsy, Progressive, run by Biogen at 13 sites in United States.
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 7 inclusion and 12 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 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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. 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: 251PP301(NCT03068468) primary endpoint was not met;further development of Gosuranemab BIIB092 in progressive supranuclear palsy will not be pursued.). 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?
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths (time frame: Day 1 through study completion (approximately 1.5 years or later)). The study lists 2 primary outcomes in all. 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 18 May 2020.