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Progressive Supranuclear PalsyPhase 1CN002-003NCT02460094

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

A Phase 1 study testing BIIB092 in people with Progressive Supranuclear Palsy, run by Biogen at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 41 to 86 years
Conditions the study is for
Progressive Supranuclear Palsy
What is being tested?
BIIB092
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
13 sitesUnited States
Study dates
2 Oct 2015to 19 Oct 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 41 to 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • The University of Alabama at Birmingham

    Birmingham, Alabama

  • Parkinsons Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida

  • The University of Chicago Department of Neurology

    Chicago, Illinois

  • The University of Texas Southwestern Medical Center

    Dallas, Texas

  • University of Florida College of Medicine

    Gainesville, Florida

  • David Geffen School of Medicine at UCLA

    Los Angeles, California

  • University of Minnesota Medical School

    Minneapolis, Minnesota

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey

  • Columbia University Medical Center

    New York, New York

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania

  • University of California San Diego

    San Diego, California

  • University of California, San Francisco, Medical Center at Parnassus

    San Francisco, California

  • University of South Florida

    Tampa, Florida

Other trials in United States

About this study

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

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.

Read the detailed description

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

Being tested
BIIB092, Placebo
Medical subject headings
Supranuclear Palsy, Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB092Drug

    Also called BMS-986168

    See Arm Descriptions for dosing information.

  • PlaceboDrug

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

Study groups in NCT02460094
Study groupRoleWhat they receive
Panel 1: BIIB092/ PlaceboExperimentalBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Receives: Drug: BIIB092; Drug: Placebo
Panel 2: BIIB092/ PlaceboExperimentalBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Receives: Drug: BIIB092; Drug: Placebo
Panel 3: BIIB092/ PlaceboExperimentalBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Receives: Drug: BIIB092; Drug: Placebo
Panel 4: BIIB092/ PlaceboExperimentalBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Receives: Drug: BIIB092; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 - Day 169

Secondary outcomes (7)

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

    Measured: Day 1 - Day 85

  2. Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum

    Measured: Day 1 - Day 169

  3. Maximum Serum Concentration (Cmax) of BIIB092

    Measured: Day 1 - Day 196

  4. Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU))

    Measured: Day 1 - Day 196

  5. Trough Serum Concentration (Ctrough) of BIIB092

    Measured: Day 1 - Day 196

  6. Serum Concentration at 4 Weeks After Dosing of BIIB092

    Measured: Day 1 - Day 196

  7. Time of Maximum Serum Concentration (Tmax)

    Measured: Day 1 - Day 196

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study start2 Oct 2015
  3. Primary completion19 Oct 2016
  4. Study completion19 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02460094
Sponsor's protocol ID
CN002-003
Acronym
CN002-003
Status last verified
Aug 2018
First submitted
20 May 2015
Last updated
4 Sep 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31122495

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIIB092 in people with Progressive Supranuclear Palsy, run by Biogen at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Day 1 - Day 169). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02460094, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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