Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:41 - 86
Updated:3/8/2019
Start Date:February 22, 2016
End Date:April 23, 2020

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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.

This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a
licensing agreement.

Key Inclusion Criteria:

1. Completed treatment in Study CN002003.

2. 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.

3. Able to tolerate Magnetic Resonance Imaging (MRI).

4. Able to perform all protocol-specified assessments and comply with the study visit
schedule.

5. 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.

6. Patient must reside outside a skilled nursing facility or dementia care facility at
the time of enrollment

7. Women of childbearing potential (WOCBP) and sexually active fertile men with partners
who are WOCBP must use highly effective birth control.

Key Exclusion Criteria:

1. 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.

2. Contraindication to undergoing a lumbar puncture (LP).

3. Recent drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental
Disorders (4th Edition).

4. Treatment with any investigational drugs (including placebo) other than BIIB092 or
placebo given in Study CN002003 or devices within 90 days prior to enrollment

5. Any vaccination within 30 days prior to study drug administration.

6. Contraindication to the MRI examination for any reason

7. Any other sound medical, psychiatric, and/or social reason as determined by the
investigator

8. Known history of human immunodeficiency virus.

9. 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.

10. Inability to be venipunctured and/or tolerate venous access.

11. 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
We found this trial at
13
sites
New Brunswick, New Jersey 08901
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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3450 Hull Road
Gainesville, Florida 32610
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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Minneapolis, Minnesota 55455
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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