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

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.

Study Overview

• Status: Terminated
• Conditions: Supranuclear Palsy, Progressive
• Intervention / Treatment: Drug: BIIB092

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2016
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Ocular Motility Disorders; Paralysis; Ophthalmoplegia; Supranuclear Palsy, Progressive
• Other Study ID Numbers: 251PP201; CN002-004 (Other Identifier: Bristol-Myers Squibb)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No