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

Progressive Supranuclear Palsy Clinical Trial

— CN002-003  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460094
• Other study ID #: CN002-003
• Status: Completed
• Phase: Phase 1
• Start date: October 2, 2015
• Est. completion date: October 19, 2016

Study information

• Verified date: August 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Progressive Supranuclear Palsy.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 19, 2016
• Est. primary completion date: October 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• BIIB092
See Arm Descriptions for dosing information.
• Placebo
See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Parkinsons Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	The University of Chicago Department of Neurology	Chicago	Illinois
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Florida College of Medicine	Gainesville	Florida
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
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	University of California San Diego	San Diego	California
United States	University of California, San Francisco, Medical Center at Parnassus	San Francisco	California
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 - Day 169
Secondary	Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid		Day 1 - Day 85
Secondary	Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum		Day 1 - Day 169
Secondary	Maximum Serum Concentration (Cmax) of BIIB092		Day 1 - Day 196
Secondary	Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU))		Day 1 - Day 196
Secondary	Trough Serum Concentration (Ctrough) of BIIB092		Day 1 - Day 196
Secondary	Serum Concentration at 4 Weeks After Dosing of BIIB092		Day 1 - Day 196
Secondary	Time of Maximum Serum Concentration (Tmax)		Day 1 - Day 196