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

NCT ID: NCT02658916

Last Updated: 2020-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-22
• Study Completion Date: 2020-03-31

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.

Detailed Description

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

Conditions

Supranuclear Palsy, Progressive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panel 1: BIIB092

BIIB092 administered by intravenous (IV) infusion, once every four weeks.

Group Type: EXPERIMENTAL

BIIB092

Intervention Type: DRUG

Same dose as corresponding CN002003 study panel.

Panel 2: BIIB092

BIIB092 administered by intravenous (IV) infusion, once every four weeks.

Group Type: EXPERIMENTAL

BIIB092

Intervention Type: DRUG

Same dose as corresponding CN002003 study panel.

Panel 3: BIIB092

BIIB092 administered by intravenous (IV) infusion, once every four weeks.

Group Type: EXPERIMENTAL

BIIB092

Intervention Type: DRUG

Same dose as corresponding CN002003 study panel.

Panel 4: BIIB092 (Expansion Panel)

BIIB092 administered by intravenous (IV) infusion, once every four weeks.

Group Type: EXPERIMENTAL

BIIB092

Intervention Type: DRUG

Same dose as corresponding CN002003 study panel.

Interventions

BIIB092

Same dose as corresponding CN002003 study panel.

Intervention Type: DRUG

Other Intervention Names

BMS-986168

Eligibility Criteria

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.

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

• Minimum Eligible Age: 41 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

The University of Alabama at Birmingham

Birmingham, Alabama, 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 California, San Francisco, Medical Center at Parnassus

San Francisco, California, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.

Boca Raton, Florida, United States

University of Florida College of Medicine

Gainesville, Florida, United States

University of South Florida

Tampa, Florida, United States

The University of Chicago Medical Center

Chicago, Illinois, 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

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

CN002-004

Identifier Type: OTHER

Identifier Source: secondary_id

251PP201

Identifier Type: -

Identifier Source: org_study_id