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

Supranuclear Palsy, Progressive Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02658916
• Other study ID #: 251PP201
• Secondary ID: CN002-004
• Status: Terminated
• Phase: Phase 1
• Start date: February 22, 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Supranuclear Palsy, Progressive

Intervention

Drug:
• BIIB092
Same dose as corresponding CN002003 study panel.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.	Boca Raton	Florida
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Florida College of Medicine	Gainesville	Florida
United States	University of California San Diego	La Jolla	California
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California, San Francisco, Medical Center at Parnassus	San Francisco	California
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Serum Trough Concentration (C-trough) of BIIB092		Up to study completion (approximately 1.5 years or later)
Secondary	End-of-Infusion Serum Concentration of BIIB092		Day 1 through study completion (approximately 1.5 years or later)
Secondary	Number of Participants with drug antibodies (anti-BIIB092) in Serum		Up to study completion (approximately 1.5 years or later)
Secondary	Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48		Baseline, Week 48