Progressive Supranuclear PalsyPhase 2NCT05819658
GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)
A Phase 2 study testing GV1001 0.56mg and GV1001 1.12mg in people with Progressive Supranuclear Palsy, run by GemVax & Kael at 5 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 41 to 85 years
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- GV1001 0.56mg and GV1001 1.12mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 14 Jun 2023to 11 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si
Kyung Hee University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Design, Prospective, Phase IIa Exploratory Clinical Trial to Evaluate the Efficacy and Safety of SC Administration of GV1001 0.56 or 1.12 mg/Day in Patients With PSP
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.
- Conditions
- Progressive Supranuclear Palsy
- Being tested
- GV1001 Placebo, GV1001 0.56mg, GV1001 1.12mg
- Keywords
- Progressive Supranuclear Palsy, GV1001
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV1001 PlaceboDrug
Also called Normal saline
0.9% normal saline
GV1001 0.56mgDrug
Also called Tertomotide 0.84mg
Lyophilized peptide from hTERT
GV1001 1.12mgDrug
Also called Tertomotide 1.68mg
Lyophilized peptide from hTERT
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. Receives: Drug: GV1001 Placebo |
| GV1001 0.56 mg | Experimental | 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. Receives: Drug: GV1001 0.56mg |
| GV1001 1.12 mg | Experimental | GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. Receives: Drug: GV1001 1.12mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks(6 months)
Secondary outcomes (21)
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.
Measured: 12 Weeks(3 months)
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.
Measured: 12 weeks (3 Months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
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.
Measured: 12 weeks(3 months)
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.
Measured: 24 weeks(6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start14 Jun 2023
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- GemVax & Kael
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Jae Kim, Study chair, GemVax & Kael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819658
- Sponsor's protocol ID
- GV1001-PSP-CL2-011
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2023
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Design, Prospective, Phase IIa Exploratory Clinical Trial to Evaluate the Efficacy and Safety of SC Administration of GV1001 0.56 or 1.12 mg/Day in Patients With PSP
- ClinicalTrials.gov ID
- NCT05819658
- Acronym / sponsor ID
- GV1001-PSP-CL2-011
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- Progressive Supranuclear Palsy, GV1001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- GemVax & KaelIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: GV1001 PlaceboPlacebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| GV1001 0.56 mg | Experimental | Drug: GV1001 0.56mgGV1001 0.56 mg SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| GV1001 1.12 mg | Experimental | Drug: GV1001 1.12mgGV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
Who may qualify
- Ages
- 41 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GV1001 PlaceboAlso: Normal saline0.9% normal saline | Drug | Placebo |
| GV1001 0.56mgAlso: Tertomotide 0.84mgLyophilized peptide from hTERT | Drug | GV1001 0.56 mg |
| GV1001 1.12mgAlso: Tertomotide 1.68mgLyophilized peptide from hTERT | Drug | GV1001 1.12 mg |
Primary outcome
Change From the Baseline in the Total Score of PSP-rating Scale
Time frame: 24 weeks(6 months)
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.
21 secondary outcomes
Change From the Baseline in the Total Score of PSP-rating Scale
Time frame: 12 Weeks(3 months)
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)
Time frame: 12 weeks (3 Months)
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)
Time frame: 24 weeks(6 months)
Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)
Time frame: 12 weeks(3 months)
Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)
Time frame: 24 weeks(6 months)
Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale
Time frame: 12 weeks(3 months)
Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale
Time frame: 24 weeks(6 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)
Time frame: 12 weeks(3 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)
Time frame: 24 weeks(6 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)
Time frame: 12 weeks(3 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)
Time frame: 24 weeks(6 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)
Time frame: 12 weeks(3 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)
Time frame: 24 weeks(6 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)
Time frame: 12 weeks(3 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)
Time frame: 24 weeks(6 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)
Time frame: 12 weeks(3 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)
Time frame: 24 weeks(6 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)
Time frame: 12 weeks(3 months)
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)
Time frame: 24 weeks(6 months)
Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)
Time frame: 12 weeks(3 months)
Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)
Time frame: 24 weeks(6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Jae Kim study chair
GemVax & Kael
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GV1001 0.56mg and GV1001 1.12mg in people with Progressive Supranuclear Palsy, run by GemVax & Kael at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From the Baseline in the Total Score of PSP-rating Scale (time frame: 24 weeks(6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.