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CompletedNCT05819658Updated Feb 10, 2026Results posted

GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)

A Phase 2 interventional study of GV1001 Placebo and GV1001 0.56mg in Progressive Supranuclear Palsy, sponsored by GemVax & Kael. Completed at 5 sites in South Korea. Open to participants aged 41 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by GemVax & Kael · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
41 Years to 85 Years
Sex
All
01

Study summary

The study will be conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy, (PSP). In 75 patients diagnosed with PSPR Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) at five hospitals in Korea, subcutaneous administration of GV1001 0.56 or 1.12 mg/day will be conducted with multicenter, randomized, double-blind, placebo-controlled, parallel design, prospective phase 2a.

Read the detailed description

This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel design, prospective, Phase 2a exploratory clinical study. If the subject and/or the subject's representative provide a written consent to participate in this clinical study, the required examinations and tests will be performed at the screening visit, and the screening period will run for 4 weeks or shorter. Subjects who are ultimately determined as eligible by the inclusion/exclusion criteria after screening will be randomized at a 1:1:1 ratio to Study Group 1 (GV1001 0.56 mg/day), Study Group 2 (GV1001 1.12 mg/day), or the placebo group depending on the study site in which they are enrolled. Depending on the randomization results, subjects will be administered the investigational product (study drug or placebo) once weekly for the first 4 weeks (1 month), and then administered 10 times at 2-week intervals for 20 weeks (5 months) for a total of 14 doses over 24 weeks (6 months). All subjects will visit the institution according to the planned clinical study schedule to receive the investigational product and to be evaluated for efficacy and safety. To ensure the objectivity and accuracy of the study results, the individuals evaluating efficacy will be limited to neurologists who have been sufficiently educated and trained, and the collection of efficacy and safety evaluation data and biomarkers will be performed in a consistent order at each visit.

02

Conditions studied

  • Progressive Supranuclear Palsy

Keywords

  • Progressive Supranuclear Palsy
  • GV1001
03

In context

Supranuclear Palsy, Progressive

162 studies on the registry are indexed under Supranuclear Palsy, Progressive; 48 are open to participants now.

This study's enrollment of 78 is above the median of 40 across 96 interventional studies indexed under Supranuclear Palsy, Progressive.

Browse Supranuclear Palsy, Progressive studies →

Lead sponsor

GemVax & Kael is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
41 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged ≥41 years to ≤ 85 years.
  • Clinical diagnosis of probable progressive supranuclear palsy (PSP).
  • Patient is on a stable therapy for a neurological drug for at least 1 month prior to screening visit.
  • Patients who are able to walk 3 meters or more independently or with assistive devices.
  • Score 15 points ≥ on the Korean Mini-Mental Status Exam (K-MMSE) at the screening visit.
  • Have reliable caregiver to accompany participant to all study visits.
  • Patients and/or their representatives who have voluntarily provided a written consent for participation in this clinical study.

Exclusion criteria

Exclusion Criteria:

  • Patients who have Presence of structural lesions or Suspected concurrent onset of central nervous system diseases based on the CT/MRI scan results and neurological examinations performed within 12 months of screening or at screening.
  • Patients with a history of known or suspected seizures.
  • Patients with a recent unexplained loss of consciousness within 3 months prior to screening or a history of significant head trauma with loss of consciousness.
  • Patients with acute or unstable cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes, or any other medical condition that can interfere with completing the clinical study.
  • Patients with hypersensitivity reactions to the ingredients of the investigational product.
  • Patients with a history of cancer within 5 years prior to screening.
  • Patients with abnormal renal function.
  • Patients with severe liver function abnormalities.
  • Patients weighing ≤35 kg.
  • Among the female subjects who does not agree to use proper contraception.
  • Pregnant or breastfeeding women.
  • Patients who participated in another clinical study within 4 weeks prior to screening and were administered investigational products or were applied investigational medical devices.
  • Patients who were administered the study drug (GV1001) of this clinical study within 12 months prior to screening.
  • Patients who participated in a clinical study for progressive supranuclear palsy within 6 months prior to screening.
  • Other patients judged by the investigator as ineligible to participate in this clinical study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.

    Drug: GV1001 Placebo

  • Experimental
    GV1001 0.56 mg

    GV1001 0.56 mg SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.

    Drug: GV1001 0.56mg

  • Experimental
    GV1001 1.12 mg

    GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.

    Drug: GV1001 1.12mg

Interventions

  • DrugGV1001 Placebo

    0.9% normal saline

    Also known as: Normal saline

  • DrugGV1001 0.56mg

    Lyophilized peptide from hTERT

    Also known as: Tertomotide 0.84mg

  • DrugGV1001 1.12mg

    Lyophilized peptide from hTERT

    Also known as: Tertomotide 1.68mg

06

What researchers measure

Primary outcomes

  1. Change From the Baseline in the Total Score of PSP-rating Scale

    Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.

    Time frame: 24 weeks(6 months)

Secondary outcomes

  1. Change From the Baseline in the Total Score of PSP-rating Scale

    Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.

    Time frame: 12 Weeks(3 months)

  2. Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

    Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.

    Time frame: 12 weeks (3 Months)

  3. Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

    Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.

    Time frame: 24 weeks(6 months)

  4. Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

    Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.

    Time frame: 12 weeks(3 months)

  5. Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

    Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.

    Time frame: 24 weeks(6 months)

  6. Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

    Change from the baseline in the England \& Schwab Activity of Daily Living (ES ADL) scale after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.

    Time frame: 12 weeks(3 months)

  7. Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

    Change from the baseline in the England \& Schwab Activity of Daily Living (ES ADL) scale after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.

    Time frame: 24 weeks(6 months)

  8. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

    Change from the baseline in the score of \[History\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 24 with a higher score indicating severely impaired cognitive function.

    Time frame: 12 weeks(3 months)

  9. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

    Change from the baseline in the score of \[History\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 24 with a higher score indicating severely impaired cognitive function.

    Time frame: 24 weeks(6 months)

  10. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

    Change from the baseline in the score of \[Mentation\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

    Time frame: 12 weeks(3 months)

  11. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

    Change from the baseline in the score of \[Mentation\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

    Time frame: 24 weeks(6 months)

  12. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

    Change from the baseline in the score of \[Bulbar\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 8 with a higher score indicating severely impaired cognitive function.

    Time frame: 12 weeks(3 months)

  13. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

    Change from the baseline in the score of \[Bulbar\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 8 with a higher score indicating severely impaired cognitive function.

    Time frame: 24 weeks(6 months)

  14. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

    Change from the baseline in the score of \[Ocular Motor\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

    Time frame: 12 weeks(3 months)

  15. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

    Change from the baseline in the score of \[Ocular Motor\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

    Time frame: 24 weeks(6 months)

  16. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

    Change from the baseline in the score of \[Limb Motor\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

    Time frame: 12 weeks(3 months)

  17. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

    Change from the baseline in the score of \[Limb Motor\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

    Time frame: 24 weeks(6 months)

  18. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

    Change from the baseline in the score of \[Midline/Gait\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 20 with a higher score indicating severely impaired cognitive function.

    Time frame: 12 weeks(3 months)

  19. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

    Change from the baseline in the score of \[Midline/Gait\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 20 with a higher score indicating severely impaired cognitive function.

    Time frame: 24 weeks(6 months)

  20. Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

    Change from the baseline in the score of each item \[Item 12\_Dysarthria\] of the PSP-rating scale after 12 weeks (3 months) of investigational product administration. Only the analysis result for Item no.12 out of a total of 28 items is described. The possible total scores range from 0 to 4 with a higher score indicating severely impaired cognitive function.

    Time frame: 12 weeks(3 months)

  21. Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

    Change from the baseline in the score of each item \[Item 12\_Dysarthria\] of the PSP-rating scale after 24 weeks (6 months) of investigational product administration. Only the analysis result for Item no.12 out of a total of 28 items is described. The possible total scores range from 0 to 4 with a higher score indicating severely impaired cognitive function.

    Time frame: 24 weeks(6 months)

07

Results

Posted Feb 10, 2026

Participant flow

Participant flow — Overall Study
MilestonePlaceboGV1001 0.56 mgGV1001 1.12 mg
Started252528
Completed222025
Not completed353

Outcome measures

PrimaryChange From the Baseline in the Total Score of PSP-rating Scale

Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Total Score of PSP-rating Scale
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Total Score of PSP-rating Scale4.10 ± 1.692.14 ± 1.786.46 ± 1.64
SecondaryChange From the Baseline in the Total Score of PSP-rating Scale

Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.

Time frame:
12 Weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Total Score of PSP-rating Scale
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Total Score of PSP-rating Scale1.42 ± 1.60-0.47 ± 1.652.75 ± 1.55
SecondaryChange From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.

Time frame:
12 weeks (3 Months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)0.25 ± 0.610.93 ± 0.640.26 ± 0.60
SecondaryChange From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)0.29 ± 0.730.35 ± 0.78-1.46 ± 0.71
SecondaryChange From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)-0.29 ± 0.51-1.06 ± 0.53-1.42 ± 0.49
SecondaryChange From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)-0.20 ± 0.55-0.89 ± 0.59-1.42 ± 0.54
SecondaryChange From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

Change from the baseline in the England \& Schwab Activity of Daily Living (ES ADL) scale after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale-2.18 ± 2.92-2.70 ± 3.02-7.12 ± 2.85
SecondaryChange From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

Change from the baseline in the England \& Schwab Activity of Daily Living (ES ADL) scale after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale-9.45 ± 3.05-8.35 ± 3.23-17.12 ± 2.99
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

Change from the baseline in the score of \[History\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 24 with a higher score indicating severely impaired cognitive function.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)-0.26 ± 0.56-0.17 ± 0.590.41 ± 0.55
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

Change from the baseline in the score of \[History\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 24 with a higher score indicating severely impaired cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)0.42 ± 0.660.90 ± 0.701.36 ± 0.64
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

Change from the baseline in the score of \[Mentation\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)0.31 ± 0.41-0.01 ± 0.410.23 ± 0.39
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

Change from the baseline in the score of \[Mentation\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)0.26 ± 0.41-0.07 ± 0.430.66 ± 0.40
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

Change from the baseline in the score of \[Bulbar\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 8 with a higher score indicating severely impaired cognitive function.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)0.35 ± 0.240.11 ± 0.25-0.08 ± 0.24
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

Change from the baseline in the score of \[Bulbar\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 8 with a higher score indicating severely impaired cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)0.49 ± 0.260.04 ± 0.280.68 ± 0.26
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

Change from the baseline in the score of \[Ocular Motor\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)-0.05 ± 0.480.08 ± 0.490.86 ± 0.46
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

Change from the baseline in the score of \[Ocular Motor\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)1.36 ± 0.440.25 ± 0.461.30 ± 0.43
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

Change from the baseline in the score of \[Limb Motor\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)0.27 ± 0.36-0.26 ± 0.380.02 ± 0.36
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

Change from the baseline in the score of \[Limb Motor\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)0.45 ± 0.52-0.07 ± 0.550.51 ± 0.50
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

Change from the baseline in the score of \[Midline/Gait\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 20 with a higher score indicating severely impaired cognitive function.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)0.26 ± 0.47-0.08 ± 0.491.19 ± 0.46
SecondaryChange From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

Change from the baseline in the score of \[Midline/Gait\] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 20 with a higher score indicating severely impaired cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)0.58 ± 0.561.28 ± 0.591.79 ± 0.54
SecondaryChange From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

Change from the baseline in the score of each item \[Item 12\_Dysarthria\] of the PSP-rating scale after 12 weeks (3 months) of investigational product administration. Only the analysis result for Item no.12 out of a total of 28 items is described. The possible total scores range from 0 to 4 with a higher score indicating severely impaired cognitive function.

Time frame:
12 weeks(3 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)0.21 ± 0.150.13 ± 0.150.06 ± 0.14
SecondaryChange From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

Change from the baseline in the score of each item \[Item 12\_Dysarthria\] of the PSP-rating scale after 24 weeks (6 months) of investigational product administration. Only the analysis result for Item no.12 out of a total of 28 items is described. The possible total scores range from 0 to 4 with a higher score indicating severely impaired cognitive function.

Time frame:
24 weeks(6 months)
Reported as:
Mean · scores on a scale
Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)
scores on a scalePlaceboGV1001 0.56 mgGV1001 1.12 mg
Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)0.44 ± 0.140.01 ± 0.150.44 ± 0.14

Adverse events

Collected over From enrollment until end of follow-up, up to 28 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/24 (0%)3/24 (12.5%)15/24 (62.5%)
GV1001 0.56 mg0/24 (0%)2/24 (8.3%)12/24 (50%)
GV1001 1.12 mg0/28 (0%)5/28 (17.9%)9/28 (32.1%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventPlaceboGV1001 0.56 mgGV1001 1.12 mg
Pneumonia aspirationInfections and infestations1/240/241/28
Infective spondylitisInfections and infestations0/241/240/28
Tuberculous pleurisyInfections and infestations1/240/240/28
Clavicle fractureInjury, poisoning and procedural complications1/240/240/28
Gastric ulcerGastrointestinal disorders1/240/240/28
Suicide attemptPsychiatric disorders0/241/240/28
Joint dislocationInjury, poisoning and procedural complications0/240/241/28
Rib fractureInjury, poisoning and procedural complications0/240/241/28
Spinal fractureInjury, poisoning and procedural complications0/240/241/28
Acute myocardial infarctionCardiac disorders0/240/241/28
Most frequent other events
Showing 10 of 11
Most frequent other events
EventPlaceboGV1001 0.56 mgGV1001 1.12 mg
Chest painGeneral disorders3/240/240/28
ConstipationGastrointestinal disorders1/243/242/28
Injection site erythemaGeneral disorders2/241/243/28
Skin lacerationInjury, poisoning and procedural complications2/242/240/28
Skin abrasionInjury, poisoning and procedural complications2/240/240/28
PyrexiaGeneral disorders2/240/241/28
Gastric ulcerGastrointestinal disorders2/240/240/28
NasopharyngitisInfections and infestations0/242/240/28
DepressionPsychiatric disorders0/242/240/28
DizzinessNervous system disorders1/242/241/28

Baseline characteristics

Sex: Female, Male
Sex: Female, Male(Participants)PlaceboGV1001 0.56 mgGV1001 1.12 mgTotal
Female119626
Male14162252
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)PlaceboGV1001 0.56 mgGV1001 1.12 mgTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(Participants)PlaceboGV1001 0.56 mgGV1001 1.12 mgTotal
South Korea25252878
PSP type
PSP type(Participants)PlaceboGV1001 0.56 mgGV1001 1.12 mgTotal
PSP-Richardson type18162155
PSP Parkinsonian type79723
Age, Categorical
Age, Categorical(Participants)PlaceboGV1001 0.56 mgGV1001 1.12 mgTotal
<=18 years0000
Between 18 and 65 years67316
>=65 years19182562
08

Study locations

5 sites
  • Seoul National University Bundang Hospital
    Seongnam-si, South Korea
  • Kyung Hee University Hospital
    Seoul, South Korea
  • Samsung Medical Center
    Seoul, South Korea
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Seoul, South Korea
  • Seoul National University Hospital
    Seoul, South Korea
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 15, 2024
  • Statistical analysis plan · Oct 10, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05819658
Lead sponsor
GemVax & Kael
Responsible party
Sponsor
First posted
Apr 19, 2023
Start date
Jun 14, 2023
Primary completion
Oct 11, 2024
Completion
Oct 11, 2024
Results posted
Feb 10, 2026
Last update
Feb 10, 2026

Study contacts

Sang Jae Kim
study chair · GemVax & Kael

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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