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CN002-003
CompletedPhase 1Multiple 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
Asset
Gosuranemab
Listed sites
13
Recruiting sites
-
Enrollment
48
actual
Study population
Frontotemporal dementia
Key I/E criteria
•MMSE ≥20•Study partner/caregiver required•MRI 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Probable or possible PSP defined as:
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
Fluid / digital biomarkers
1 endpointPercent 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 endpointsSafety 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
Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum
Time frame:Day 1 - Day 169
descriptive
Maximum Serum Concentration (Cmax) of BIIB092
Time frame:Day 1 - Day 196
concentration, descriptive
Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU))
Time frame:Day 1 - Day 196
concentration, descriptive
Time of Maximum Serum Concentration (Tmax)
Time frame:Day 1 - Day 196
concentration, descriptive
Other (unclassified)
2 endpointsTrough Serum Concentration (Ctrough) of BIIB092
Time frame:Day 1 - Day 196
concentration, descriptive
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.
Registry references + supporting bibliography
- PMID31122495via DERIVED
Provenance
Sources
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.