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

Sponsor
Biogen (Industry)
Overall Status
Terminated
CT.gov ID
NCT02658916
Collaborator
(none)
47
Enrollment
13
Locations
4
Arms
49.2
Actual Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
47 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 :
Feb 22, 2016
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • BMS-986168

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)]

    2. 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

    1. Serum Trough Concentration (C-trough) of BIIB092 [Up to study completion (approximately 1.5 years or later)]

    2. End-of-Infusion Serum Concentration of BIIB092 [Day 1 through study completion (approximately 1.5 years or later)]

    3. Number of Participants with drug antibodies (anti-BIIB092) in Serum [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 [Baseline, Week 48]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    41 Years to 86 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 University of California San Diego La Jolla California United States 92037
    3 David Geffen School of Medicine at UCLA Los Angeles California United States 90024
    4 University of California, San Francisco, Medical Center at Parnassus San Francisco California United States 94158
    5 Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc. Boca Raton Florida United States 33486
    6 University of Florida College of Medicine Gainesville Florida United States 32607
    7 University of South Florida Tampa Florida United States 33612
    8 The University of Chicago Medical Center Chicago Illinois United States 60637
    9 University of Minnesota Medical School Minneapolis Minnesota United States 55455-0341
    10 Robert Wood Johnson Medical School New Brunswick New Jersey United States 08901-1962
    11 Columbia University Medical Center New York New York United States 10032
    12 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4206
    13 The University of Texas Southwestern Medical Center Dallas Texas United States 75390-8830

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT02658916
    Other Study ID Numbers:
    • 251PP201
    • CN002-004
    First Posted:
    Jan 20, 2016
    Last Update Posted:
    May 18, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Supranuclear Palsy, Progressive

    Study Results

    No Results Posted as of May 18, 2020