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CompletedPhase 2

Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011

Twelve-months Extension Study to Explore the Long-Term Safety and Efficacy of Subcutaneous Administration of GV1001 1.12 mg/Day in Patients With Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011

Lead sponsor

GemVax & Kael

Asset

GV1001

Listed sites

5

Recruiting sites

-

Enrollment

67

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Age 41-85

Primary endpoints

•Adverse Event•Hematological tests WBC(10^3/µl)•Hematological tests RBC(10^6/µl)

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 IDGV1001-PSP-CL2-011-E
NCT IDNCT06235775

Timeline

Milestones

Study start2023-12-12actual
Study first posted2024-02-01actual
Primary completion2025-09-01actual
Study completion2025-09-01actual
Last update posted2025-11-21actual

Assets

Drug assets

GV1001

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age41 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24
•A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator)
•Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial

Exclusion criteria

•Patients deemed unsuitable by the investigator to participate in this extension study
•Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception.
•Pregnant women or breastfeeding women

Endpoints (39)

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)
31
Global cognition
5
Function / daily living
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Global cognition

5 endpoints
Other/protocol endpoint

Change from the baseline in the total score of PSP-rating scale

Time frame:18 months

ratio, descriptive

Other/protocol endpoint

Change from the baseline in the score of each domain of the PSP-rating scale

Time frame:18 months

ratio, descriptive

Other/protocol endpoint

Change from the baseline in the score of each item of the PSP-rating scale

Time frame:18 months

ratio, descriptive

Other/protocol endpoint

Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

Time frame:18 months

ratio, descriptive

Other/protocol endpoint

Change from the baseline in the Korean Frontal Assessment Battery (K-FAB)

Time frame:18 months

ratio, descriptive

Function / daily living

1 endpoint
Other/protocol endpoint

Change from the baseline in the England & Schwab Activity of Daily Living (ES ADL) scale

Time frame:18 months

ratio, descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Adverse Event

Time frame:12 months

event count, event

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Blood Pressure (mmHG)

Time frame:12 months

change from baseline, improvement

Other (unclassified)

31 endpoints
Primary/protocol endpoint/low confidence

Change in Hematological tests WBC(10^3/µl)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests RBC(10^6/µl)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests Hemoglobin(g/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests Hematocrit(%)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests Platelets count(10^3/µl)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests WBC differential count (Neutrophils(%))

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests WBC differential count( Lymphocytes(%))

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests WBC differential count( Monocytes(%))

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests WBC differential count(Eosinophils(%))

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematological tests WBC differential count(Basophils(%))

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests BUN(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests Creatinine(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests Uric acid(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests Total bilirubin(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests Albumin(g/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests Total Protein(g/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests ALT(U/L)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests AST(U/L)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests γ-GTP(U/L)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests Alkaline phosphatase(U/L)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests Glucose(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Hematochemical tests Total Cholesterol(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in urine tests Protein-Albumin(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in urine tests Glucose(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in urine tests Ketones(mg/dL)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in urine tests WBC(HPF)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in urine tests Blood-RBC(HPF)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Pulse rate(beats per min)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Respiratory rate(breaths per min)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

temperature(℃)

Time frame:12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

EKG

Time frame:12 months

descriptive

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.