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

• ClinicalTrials.gov Identifier: NCT02658916
• Recruitment Status: Terminated
• First Posted: January 20, 2016
• Last Update Posted: May 18, 2020
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

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
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.

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: February 22, 2016
• Actual Primary Completion Date: March 31, 2020
• Actual Study Completion Date: March 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 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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Medical Director; Biogen

More Information

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT02658916
• Other Study ID Numbers: 251PP201; CN002-004 ( Other Identifier: Bristol-Myers Squibb )
• First Posted: January 20, 2016
• Last Update Posted: May 18, 2020
• Last Verified: May 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; Paralysis; Neurologic Manifestations; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Eye Diseases