Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy

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Brief Title

Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy

Brief Summary

      The purpose of this study is to evaluate the safety and tolerability of multiple ascending
      intravenous infusions of BMS-986168 and to assess the pharmacokinetics and immunogenicity of
      BIIB092, and pharmacodynamics of BIIB092 on cerebrospinal fluid (CSF) extracellular tau
      (eTau) concentrations in participants with Progressive Supranuclear Palsy.
    

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

Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary Outcome

 Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid

Condition

Progressive Supranuclear Palsy

Intervention

BIIB092

Study Arms / Comparison Groups

 Panel 1: BIIB092/ Placebo
Description:  BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses 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

48

Start Date

October 2, 2015

Completion Date

October 19, 2016

Primary Completion Date

October 19, 2016

Eligibility Criteria

        Inclusion Criteria

          1. Probable or possible PSP defined as:

               -  at least a 12-month history of postural instability or falls during the first 3
                  years that symptoms are present

               -  a decreased downward saccade velocity at screening defined as observable eye
                  movement deviation from the "main sequence" linear relationship between saccade
                  amplitude and saccade velocity; or supranuclear ophthalmoplegia defined as 50%
                  reduction in upward gaze or 30% reduction in downward gaze; and

               -  age at symptom onset of 40 to 85 years by history and current age between 41 and
                  86 years, inclusive, at the time of screening; and

               -  an akinetic-rigid syndrome with prominent axial rigidity.

               -  presence of symptoms for less than 5 years.

          2. Body weight range of ≥ 43 kg/95 lbs to ≤ 118 kg/260 lbs.

          3. Able to tolerate 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. Score ≥ 20 on the Mini Mental State Exam (MMSE) at screening.

          7. Patient must reside outside a skilled nursing facility or dementia care facility at
             the time of screening, and admission to such a facility is not planned. Residence in
             an assisted living facility is allowed.

          8. Ability to ambulate independently or with assistance defined as the ability to take at
             least 5 steps with a walker (guarding is allowed provided there is no contact) or the
             ability to take at least 5 steps without a walker or cane with the assistance of
             another person who can only have contact with one upper extremity.

          9. Stable on other chronic medications for at least 30 days prior to screening.

         10. Women of child bearing potential (WOCBP) and sexually active fertile men with partners
             who are WOCBP must use highly effective birth control.

        Exclusion Criteria

          1. Presence of other significant neurological or psychiatric disorders.

          2. History of or screening brain MRI scan indicative of significant abnormality.

          3. History of cancer within 5 years of screening with the exception of fully excised
             non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for
             at least 6 months.

          4. History of clinically significant hematological, endocrine, cardiovascular, renal,
             hepatic, gastrointestinal, or neurological disease.

          5. Inability to be venipunctured and/or tolerate venous access.

          6. Contraindication to undergoing an LP.

          7. Recent drug or alcohol abuse as defined in DSM IV.

          8. Treatment with any investigational drugs (including placebo) or devices within 90 days
             prior to screening.

          9. Contraindication to the MRI examination for any reason

         10. History of a clinically significant medical condition that would interfere with the
             patient's ability to comply with study instructions, would place the patient at
             increased risk, or might confound the interpretation of the study results.

         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
      

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

NCT02460094

Organization ID

CN002-003


Responsible Party

Sponsor

Study Sponsor

Biogen


Study Sponsor

Medical Director, Study Director, Biogen


Verification Date

August 2018