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Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy (CN002-003)

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ClinicalTrials.gov Identifier: NCT02460094
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Drug: BIIB092 Drug: Placebo Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy
Actual Study Start Date : October 2, 2015
Actual Primary Completion Date : October 19, 2016
Actual Study Completion Date : October 19, 2016


Arm Intervention/treatment
Experimental: Panel 1: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Drug: BIIB092
See Arm Descriptions for dosing information.
Other Name: BMS-986168

Drug: Placebo
See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)

Experimental: Panel 2: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Drug: BIIB092
See Arm Descriptions for dosing information.
Other Name: BMS-986168

Drug: Placebo
See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)

Experimental: Panel 3: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Drug: BIIB092
See Arm Descriptions for dosing information.
Other Name: BMS-986168

Drug: Placebo
See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)

Experimental: Panel 4: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Drug: BIIB092
See Arm Descriptions for dosing information.
Other Name: BMS-986168

Drug: Placebo
See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)




Primary Outcome Measures :
  1. Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 - Day 169 ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid [ Time Frame: Day 1 - Day 85 ]
  2. Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum [ Time Frame: Day 1 - Day 169 ]
  3. Maximum Serum Concentration (Cmax) of BIIB092 [ Time Frame: Day 1 - Day 196 ]
  4. Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU)) [ Time Frame: Day 1 - Day 196 ]
  5. Trough Serum Concentration (Ctrough) of BIIB092 [ Time Frame: Day 1 - Day 196 ]
  6. Serum Concentration at 4 Weeks After Dosing of BIIB092 [ Time Frame: Day 1 - Day 196 ]
  7. Time of Maximum Serum Concentration (Tmax) [ Time Frame: Day 1 - Day 196 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460094


Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, United States
United States, Florida
Parkinsons Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
United States, Illinois
The University of Chicago Department of Neurology
Chicago, Illinois, United States
United States, Minnesota
University of Minnesota Medical School
Minneapolis, Minnesota, United States
United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
United States, New York
Columbia University Medical Center
New York, New York, United States
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02460094     History of Changes
Other Study ID Numbers: CN002-003
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms