Vanderbilt Clinical Trials

Study of BIIB092 in Participants With Progressive Supranuclear Palsy

Purpose

The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities. The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.

Condition

Supranuclear Palsy, Progressive

Eligibility

Eligible Ages: Between 41 Years and 86 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Participants with probable or possible PSP - Able to ambulate independently or with assistance - Able to tolerate MRI - Have reliable caregiver to accompany participant to all study visits - Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening - Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned

Exclusion Criteria

Presence of other significant neurological or psychiatric disorders - Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neuron disease - History of early, prominent rapid eye movement (REM) sleep behavior disorder - History of or screening brain MRI scan indicative of significant abnormality - Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental BIIB092	Participants will receive BIIB092 50 mg/ml intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.	Drug: BIIB092 BIIB092 intravenous infusion on specified days Other names: BMS-986168
Placebo Comparator Placebo	Participants will receive BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.	Drug: Placebo Placebo intravenous infusion on specified days

More Details

Status: Terminated
Sponsor: Biogen

Study Contact

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.