Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003
- Registration Number
- NCT02658916
- Lead Sponsor
- Biogen
- Brief 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). 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
- 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.
Key
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel 1: BIIB092 BIIB092 BIIB092 administered by intravenous (IV) infusion, once every four weeks. Panel 2: BIIB092 BIIB092 BIIB092 administered by intravenous (IV) infusion, once every four weeks. Panel 3: BIIB092 BIIB092 BIIB092 administered by intravenous (IV) infusion, once every four weeks. Panel 4: BIIB092 (Expansion Panel) BIIB092 BIIB092 administered by intravenous (IV) infusion, once every four weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths 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 Day 1 through study completion (approximately 1.5 years or later)
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48 Baseline, Week 48 End-of-Infusion Serum Concentration of BIIB092 Day 1 through study completion (approximately 1.5 years or later) Number of Participants with drug antibodies (anti-BIIB092) in Serum Up to study completion (approximately 1.5 years or later) Serum Trough Concentration (C-trough) of BIIB092 Up to study completion (approximately 1.5 years or later)
Trial Locations
- Locations (13)
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
🇺🇸Boca Raton, Florida, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of South Florida
🇺🇸Tampa, Florida, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, San Francisco, Medical Center at Parnassus
🇺🇸San Francisco, California, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Minnesota Medical School
🇺🇸Minneapolis, Minnesota, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States