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

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ClinicalTrials.gov Identifier: NCT02658916
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Supranuclear Palsy, Progressive Drug: BIIB092 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 22, 2016
Estimated Primary Completion Date : April 23, 2020
Estimated Study Completion Date : April 23, 2020


Arm Intervention/treatment
Experimental: Panel 1: BIIB092
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Drug: BIIB092
Same dose as corresponding CN002003 study panel.
Other Name: BMS-986168

Experimental: Panel 2: BIIB092
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Drug: BIIB092
Same dose as corresponding CN002003 study panel.
Other Name: BMS-986168

Experimental: Panel 3: BIIB092
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Drug: BIIB092
Same dose as corresponding CN002003 study panel.
Other Name: BMS-986168

Experimental: Panel 4: BIIB092 (Expansion Panel)
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
Drug: BIIB092
Same dose as corresponding CN002003 study panel.
Other Name: BMS-986168




Primary Outcome Measures :
  1. 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) ]
  2. 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 Measures :
  1. Serum Trough Concentration (C-trough) of BIIB092 [ Time Frame: Up to study completion (approximately 1.5 years or later) ]
  2. End-of-Infusion Serum Concentration of BIIB092 [ Time Frame: Day 1 through study completion (approximately 1.5 years or later) ]
  3. Number of Participants with drug antibodies (anti-BIIB092) in Serum [ Time Frame: Up to study completion (approximately 1.5 years or later) ]
  4. Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48 [ Time Frame: Baseline, Week 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658916


Locations
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United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California San Diego
La Jolla, California, United States, 92037
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90024
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, United States, 94158
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
Boca Raton, Florida, United States, 33486
University of Florida College of Medicine
Gainesville, Florida, United States, 32607
University of South Florida
Tampa, Florida, United States, 33612
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Minnesota
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455-0341
United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901-1962
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4206
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8830
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02658916     History of Changes
Other Study ID Numbers: 251PP201
CN002-004 ( Other Identifier: Bristol-Myers Squibb )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms