Overview

This trial is active, not recruiting.

Condition progressive supranuclear palsy
Treatments bms-986168, placebo
Phase phase 1
Sponsor Bristol-Myers Squibb
Start date September 2015
End date May 2017
Trial size 48 participants
Trial identifier NCT02460094, CN002-003

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 pharmacodynamics of BMS-986168 on cerebrospinal fluid (CSF) extracellular tau (eTau) concentrations in patients with Progressive Supranuclear Palsy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
BMS-986168 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
bms-986168
placebo
(0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)
(Experimental)
BMS-986168 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
bms-986168
placebo
(0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)
(Experimental)
BMS-986168 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
bms-986168
placebo
(0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)

Primary Outcomes

Measure
Safety and tolerability.
time frame: Day 1 - Day 169

Secondary Outcomes

Measure
Pharmacokinetics of BMS-986168 in serum.
time frame: Day 1 - Day 169
Pharmacodynamic (PD) effects of BMS-986168 on extracellular tau (eTau) in cerebrospinal fluid.
time frame: Day 1 - Day 169
Immunogenicity of BMS-986168 measured by presence or absence of anti-BMS-986168 antibodies in serum.
time frame: Day 1 - Day 169

Eligibility Criteria

Male or female participants from 41 years up to 86 years old.

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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy
Principal investigator Adam Boxer
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.