Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003
Primary Purpose
Supranuclear Palsy, Progressive
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BIIB092
Sponsored by
About this trial
This is an interventional treatment trial for Supranuclear Palsy, Progressive
Eligibility Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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
Sites / Locations
- The University of Alabama at Birmingham
- University of California San Diego
- David Geffen School of Medicine at UCLA
- University of California, San Francisco, Medical Center at Parnassus
- Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
- University of Florida College of Medicine
- University of South Florida
- The University of Chicago Medical Center
- University of Minnesota Medical School
- Robert Wood Johnson Medical School
- Columbia University Medical Center
- Hospital of the University of Pennsylvania
- The University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Panel 1: BIIB092
Panel 2: BIIB092
Panel 3: BIIB092
Panel 4: BIIB092 (Expansion Panel)
Arm Description
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths
Percentage of Participants with Marked Abnormalities in Clinical Laboratory Tests, Vital sign Measurements, ECGs, and Physical and Neurological Examinations
Secondary Outcome Measures
Serum Trough Concentration (C-trough) of BIIB092
End-of-Infusion Serum Concentration of BIIB092
Number of Participants with drug antibodies (anti-BIIB092) in Serum
Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02658916
Brief Title
Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
251PP301(NCT03068468) primary endpoint was not met;further development of Gosuranemab BIIB092 in progressive supranuclear palsy will not be pursued.
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supranuclear Palsy, Progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Panel 1: BIIB092
Arm Type
Experimental
Arm Description
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Arm Title
Panel 2: BIIB092
Arm Type
Experimental
Arm Description
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Arm Title
Panel 3: BIIB092
Arm Type
Experimental
Arm Description
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Arm Title
Panel 4: BIIB092 (Expansion Panel)
Arm Type
Experimental
Arm Description
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Intervention Type
Drug
Intervention Name(s)
BIIB092
Other Intervention Name(s)
BMS-986168
Intervention Description
Same dose as corresponding CN002003 study panel.
Primary Outcome Measure Information:
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
Serum Trough Concentration (C-trough) of BIIB092
Time Frame
Up to study completion (approximately 1.5 years or later)
Title
End-of-Infusion Serum Concentration of BIIB092
Time Frame
Day 1 through study completion (approximately 1.5 years or later)
Title
Number of Participants with drug antibodies (anti-BIIB092) in Serum
Time Frame
Up to study completion (approximately 1.5 years or later)
Title
Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48
Time Frame
Baseline, Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of California, San Francisco, Medical Center at Parnassus
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Minnesota Medical School
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0341
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901-1962
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4206
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8830
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003
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