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TerminatedPhase 1

Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003

A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003

Lead sponsor

Biogen

Asset

Gosuranemab

Listed sites

13

Recruiting sites

-

Enrollment

47

actual

Study population

Frontotemporal dementia

Key I/E criteria

Study partner/caregiver requiredMRI contraindications excluded

Primary endpoints

Adverse Events (AEs), Serious Adverse Events (SAEs)Marked Abnormalities in Clinical Laboratory Tests, Vital sign Measurements

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID251PP201
Secondary IDCN002-004Bristol-Myers Squibb
NCT IDNCT02658916

Timeline

Milestones

Study first posted2016-01-20estimated
Study start2016-02-22actual
Primary completion2020-03-31actual
Study completion2020-03-31actual
Last update posted2020-05-18actual

Assets

Drug assets

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age41 Years
Maximum age86 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion Criteria:

1. Completed treatment in Study CN002003.

2. A diagnosis of probable or possible PSP consistent with Study CN002003 criteria with no new medical information or diagnoses since enrollment into Study CN002003 that might confer doubt on the PSP diagnosis.

3. Able to tolerate Magnetic Resonance Imaging (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. Patient must reside outside a skilled nursing facility or dementia care facility at the time of enrollment

7. Women of childbearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use highly effective birth control

Exclusion criteria

1. Presence of an unstable, clinically significant medical condition other than PSP including, but not limited to: hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, immunological, psychological or neurological disease or malignancy.

2. Contraindication to undergoing a lumbar puncture (LP).

3. Recent drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition).

4. Treatment with any investigational drugs (including placebo) other than BIIB092 or placebo given in Study CN002003 or devices within 90 days prior to enrollment

5. Any vaccination within 30 days prior to study drug administration.

6. Contraindication to the MRI examination for any reason

7. Any other sound medical, psychiatric, and/or social reason as determined by the investigator

8. Known history of human immunodeficiency virus.

9. Evidence of organ dysfunction or significant deterioration from prior values in CN002003 beyond what is consistent with the target population or that would place the patient at increased risk or risk of early study discontinuation.

10. Inability to be venipunctured and/or tolerate venous access.

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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
3
Safety / tolerability / PK
2
Fluid / digital biomarkers
1

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48

Time frame:Baseline, Week 48

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths

Time frame:Day 1 through study completion (approximately 1.5 years or later)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants with Marked Abnormalities in Clinical Laboratory Tests, Vital sign Measurements, ECGs, and Physical and Neurological Examinations

Time frame:Day 1 through study completion (approximately 1.5 years or later)

threshold achievement, event

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Serum Trough Concentration (C-trough) of BIIB092

Time frame:Up to study completion (approximately 1.5 years or later)

concentration, descriptive

Secondary/protocol endpoint/low confidence

End-of-Infusion Serum Concentration of BIIB092

Time frame:Day 1 through study completion (approximately 1.5 years or later)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Number of Participants with drug antibodies (anti-BIIB092) in Serum

Time frame:Up to study completion (approximately 1.5 years or later)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.