Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy
CN002-003
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy
1 other identifier
interventional
48
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2015
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedStudy Start
First participant enrolled
October 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2016
CompletedSeptember 4, 2018
August 1, 2018
1 year
May 20, 2015
August 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 - Day 169
Secondary Outcomes (7)
Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid
Day 1 - Day 85
Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum
Day 1 - Day 169
Maximum Serum Concentration (Cmax) of BIIB092
Day 1 - Day 196
Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU))
Day 1 - Day 196
Trough Serum Concentration (Ctrough) of BIIB092
Day 1 - Day 196
- +2 more secondary outcomes
Study Arms (4)
Panel 1: BIIB092/ Placebo
EXPERIMENTALBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Panel 2: BIIB092/ Placebo
EXPERIMENTALBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Panel 3: BIIB092/ Placebo
EXPERIMENTALBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Panel 4: BIIB092/ Placebo
EXPERIMENTALBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Interventions
See Arm Descriptions for dosing information.
See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)
Eligibility Criteria
You may qualify if:
- 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.
- Body weight range of ≥ 43 kg/95 lbs to ≤ 118 kg/260 lbs.
- Able to tolerate MRI.
- Able to perform all protocol-specified assessments and comply with the study visit schedule.
- 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.
- Score ≥ 20 on the Mini Mental State Exam (MMSE) at screening.
- 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.
- 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.
- Stable on other chronic medications for at least 30 days prior to screening.
- Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use highly effective birth control.
You may not qualify if:
- Presence of other significant neurological or psychiatric disorders.
- History of or screening brain MRI scan indicative of significant abnormality.
- 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.
- History of clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease.
- Inability to be venipunctured and/or tolerate venous access.
- Contraindication to undergoing an LP.
- Recent drug or alcohol abuse as defined in DSM IV.
- Treatment with any investigational drugs (including placebo) or devices within 90 days prior to screening.
- Contraindication to the MRI examination for any reason
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (13)
The University of Alabama at Birmingham
Birmingham, Alabama, United States
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
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
The University of Chicago Department of Neurology
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
Related Publications (1)
Boxer AL, Qureshi I, Ahlijanian M, Grundman M, Golbe LI, Litvan I, Honig LS, Tuite P, McFarland NR, O'Suilleabhain P, Xie T, Tirucherai GS, Bechtold C, Bordelon Y, Geldmacher DS, Grossman M, Isaacson S, Zesiewicz T, Olsson T, Muralidharan KK, Graham DL, O'Gorman J, Haeberlein SB, Dam T. Safety of the tau-directed monoclonal antibody BIIB092 in progressive supranuclear palsy: a randomised, placebo-controlled, multiple ascending dose phase 1b trial. Lancet Neurol. 2019 Jun;18(6):549-558. doi: 10.1016/S1474-4422(19)30139-5.
PMID: 31122495DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2015
First Posted
June 2, 2015
Study Start
October 2, 2015
Primary Completion
October 19, 2016
Study Completion
October 19, 2016
Last Updated
September 4, 2018
Record last verified: 2018-08