Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PASSPORT)

Biogen

Status and phase: Terminated; Phase 2

Conditions: Supranuclear Palsy, Progressive

Treatments: Drug: BIIB092; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03068468

CN002-012 (Other Identifier)

251PP301

2016-002554-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 490 patients

Sex: All

Ages: 41 to 86 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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490 participants in 2 patient groups, including a placebo group

BIIB092

Experimental group

Description:

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.

Treatment:

Drug: BIIB092

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo