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Eligibility
for people ages 41–86
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) infusions of BMS-986168 in patients with Progressive Supranuclear Palsy (PSP). The study will also assess the pharmacodynamic (PD) effects of BMS-986168 on cerebrospinal fluid (CSF) extracellular tau (eTau), pharmacokinetics (PK), and immunogenicity of BMS-986168 in patients with Progressive Supranuclear Palsy.

Official Title

A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003

Keywords

Progressive Supranuclear Palsy

Eligibility

You can join if…

Open to people ages 41–86

  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.

You CAN'T join if...

  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 BMS-986168 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

Locations

  • David Geffen School of Medicine at UCLA
    Los Angeles, California, United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
ID
NCT02658916
Phase
Phase 1
Lead Scientist
Adam Boxer
Study Type
Interventional
Last Updated
February 2016