Study Stopped
251PP301(NCT03068468) primary endpoint was not met;further development of Gosuranemab BIIB092 in progressive supranuclear palsy will not be pursued.
Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003
A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003
2 other identifiers
interventional
47
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2016
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedStudy Start
First participant enrolled
February 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedMay 18, 2020
May 1, 2020
4.1 years
January 13, 2016
May 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Serum Trough Concentration (C-trough) of BIIB092
Up to study completion (approximately 1.5 years or later)
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)
Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48
Baseline, Week 48
Study Arms (4)
Panel 1: BIIB092
EXPERIMENTALBIIB092 administered by intravenous (IV) infusion, once every four weeks.
Panel 2: BIIB092
EXPERIMENTALBIIB092 administered by intravenous (IV) infusion, once every four weeks.
Panel 3: BIIB092
EXPERIMENTALBIIB092 administered by intravenous (IV) infusion, once every four weeks.
Panel 4: BIIB092 (Expansion Panel)
EXPERIMENTALBIIB092 administered by intravenous (IV) infusion, once every four weeks.
Interventions
Same dose as corresponding CN002003 study panel.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (13)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California San Diego
La Jolla, California, 92037, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90024, United States
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, 94158, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
Boca Raton, Florida, 33486, United States
University of Florida College of Medicine
Gainesville, Florida, 32607, United States
University of South Florida
Tampa, Florida, 33612, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455-0341, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901-1962, United States
Columbia University Medical Center
New York, New York, 10032, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4206, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8830, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
January 20, 2016
Study Start
February 22, 2016
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
May 18, 2020
Record last verified: 2020-05