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CN002-003

CompletedPhase 1

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

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

Lead sponsor

Biogen

Asset

Gosuranemab

Listed sites

13

Recruiting sites

-

Enrollment

48

actual

Study population

Frontotemporal dementia

Key I/E criteria

MMSE ≥20Study partner/caregiver requiredMRI contraindications excluded

Primary endpoint

Safety and Tolerability

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 IDCN002-003
NCT IDNCT02460094

Timeline

Milestones

Study first posted2015-06-02estimated
Study start2015-10-02actual
Primary completion2016-10-19actual
Study completion2016-10-19actual
Last update posted2018-09-04actual

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

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

Endpoints (8)

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

Safety / tolerability / PK
5
Other (unclassified)
2
Fluid / digital biomarkers
1

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid

Time frame:Day 1 - Day 85

percent change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Day 1 - Day 169

threshold achievement, event

Secondary/protocol endpoint

Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum

Time frame:Day 1 - Day 169

descriptive

Secondary/protocol endpoint

Maximum Serum Concentration (Cmax) of BIIB092

Time frame:Day 1 - Day 196

concentration, descriptive

Secondary/protocol endpoint

Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU))

Time frame:Day 1 - Day 196

concentration, descriptive

Secondary/protocol endpoint

Time of Maximum Serum Concentration (Tmax)

Time frame:Day 1 - Day 196

concentration, descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Trough Serum Concentration (Ctrough) of BIIB092

Time frame:Day 1 - Day 196

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum Concentration at 4 Weeks After Dosing of BIIB092

Time frame:Day 1 - Day 196

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.