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

NCT ID: NCT02460094

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-02
• Study Completion Date: 2016-10-19

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.

Conditions

Progressive Supranuclear Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Panel 1: BIIB092/ Placebo

BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.

Group Type: EXPERIMENTAL

BIIB092

Intervention Type: DRUG

See Arm Descriptions for dosing information.

Placebo

Intervention Type: DRUG

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

Panel 2: BIIB092/ Placebo

BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.

Group Type: EXPERIMENTAL

BIIB092

Intervention Type: DRUG

See Arm Descriptions for dosing information.

Placebo

Intervention Type: DRUG

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

Panel 3: BIIB092/ Placebo

BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.

Group Type: EXPERIMENTAL

BIIB092

Intervention Type: DRUG

See Arm Descriptions for dosing information.

Placebo

Intervention Type: DRUG

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

Panel 4: BIIB092/ Placebo

BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.

Group Type: EXPERIMENTAL

BIIB092

Intervention Type: DRUG

See Arm Descriptions for dosing information.

Placebo

Intervention Type: DRUG

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

Interventions

BIIB092

See Arm Descriptions for dosing information.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

BMS-986168

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

• Minimum Eligible Age: 41 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31122495 (View on PubMed)

Other Identifiers

CN002-003

Identifier Type: -

Identifier Source: org_study_id