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Completed

NCT Number: NCT06235775

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

The study will be conducted by the Sponsor to evaluate Twelve-months Long-Term Safety and Efficacy of GV1001 (1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy(PSP). In 75 patients diagnosed with PSP Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) who Completed Study GV1001-PSP-CL2-011.

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Key information

Conditions

Progressive Supranuclear Palsy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Age range

41 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, South Korea

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About this study

In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.

In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GV1001 Placebo

Drug

0.9% normal saline

Other names: Normal saline

GV1001 1.12mg

Drug

Lyophilized peptide from hTERT

Other names: Tertomotide 1.68mg

Primary outcomes

  1. Adverse Event

    Time frame: 12 months

    Adverse Event

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

    Time frame: 12 months

    WBC(10^3/µl)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    RBC(10^6/µl)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  4. Change in Hematological tests Hemoglobin(g/dL)

    Time frame: 12 months

    Hemoglobin(g/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  5. Change in Hematological tests Hematocrit(%)

    Time frame: 12 months

    Hematocrit(%)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    Platelets count(10^3/µl)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    WBC differential count (Neutrophils(%)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    Lymphocytes(%)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    Monocytes(%)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    Eosinophils(%)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    Basophils(%)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  12. Change in Hematochemical tests BUN(mg/dL)

    Time frame: 12 months

    BUN(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  13. Change in Hematochemical tests Creatinine(mg/dL)

    Time frame: 12 months

    Creatinine(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  14. Change in Hematochemical tests Uric acid(mg/dL)

    Time frame: 12 months

    Uric acid(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  15. Change in Hematochemical tests Total bilirubin(mg/dL)

    Time frame: 12 months

    Total bilirubin(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  16. Change in Hematochemical tests Albumin(g/dL)

    Time frame: 12 months

    Albumin(g/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  17. Change in Hematochemical tests Total Protein(g/dL)

    Time frame: 12 months

    Total Protein(g/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  18. Change in Hematochemical tests ALT(U/L)

    Time frame: 12 months

    ALT(U/L)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  19. Change in Hematochemical tests AST(U/L)

    Time frame: 12 months

    AST(U/L)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    γ-GTP(U/L)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  21. Change in Hematochemical tests Alkaline phosphatase(U/L)

    Time frame: 12 months

    Alkaline phosphatase(U/L)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  22. Change in Hematochemical tests Glucose(mg/dL)

    Time frame: 12 months

    Glucose(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  23. Change in Hematochemical tests Total Cholesterol(mg/dL)

    Time frame: 12 months

    Total Cholesterol(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

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

    Time frame: 12 months

    Protein-Albumin(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  25. Change in urine tests Glucose(mg/dL)

    Time frame: 12 months

    Glucose(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  26. Change in urine tests Ketones(mg/dL)

    Time frame: 12 months

    Ketones(mg/dL)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  27. Change in urine tests WBC(HPF)

    Time frame: 12 months

    WBC(HPF)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  28. Change in urine tests Blood-RBC(HPF)

    Time frame: 12 months

    Blood-RBC(HPF)

    For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

  29. Blood Pressure (mmHG)

    Time frame: 12 months

    Change in Blood Pressure (mmHG)

  30. Pulse rate(beats per min)

    Time frame: 12 months

    Change in Pulse rate(beats per min)

  31. Respiratory rate(breaths per min)

    Time frame: 12 months

    Change in Respiratory rate(breaths per min)

  32. temperature(℃)

    Time frame: 12 months

    Change in temperature(℃)

  33. EKG

    Time frame: 12 months

    EKG result(normal or abnormal)

Other outcomes

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

    Time frame: 18 months

    Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 72 weeks (18 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.

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

    Time frame: 18 months

    Change from the baseline in the score of each domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 72 weeks (18 months) and 24 weeks (6 months) of investigational product administration. Each domain is rated from different range (0 to 8, 16, 20 or 24) with a higher total score indicating severely impaired cognitive function.

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

    Time frame: 18 months

    Change from the baseline in the score of each item of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 72 weeks (18 months) of investigational product administration. Each item is rated from different range (0 to 2 or 4) with a higher total score indicating severely impaired cognitive function.

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

    Time frame: 18 months

    Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 72 weeks (18 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.

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

    Time frame: 18 months

    Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 72 weeks (18 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.

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

    Time frame: 18 months

    Change from the baseline in the England & Schwab Activity of Daily Living (ES ADL) scale after 72 weeks (18 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.

Sponsors and collaborators

Lead sponsor

GemVax & Kael

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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