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

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Brief Title

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

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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths

Secondary Outcome

 Serum Trough Concentration (C-trough) of BIIB092

Condition

Supranuclear Palsy, Progressive

Intervention

BIIB092

Study Arms / Comparison Groups

 Panel 1: BIIB092
Description:  BIIB092 administered by intravenous (IV) infusion, once every four weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

47

Start Date

February 22, 2016

Completion Date

March 31, 2020

Primary Completion Date

March 31, 2020

Eligibility 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
      

Gender

All

Ages

41 Years - 86 Years

Accepts Healthy Volunteers

No

Contacts

Medical Director, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02658916

Organization ID

251PP201

Secondary IDs

CN002-004

Responsible Party

Sponsor

Study Sponsor

Biogen


Study Sponsor

Medical Director, Study Director, Biogen


Verification Date

May 2020