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

NCT06235775 | Completed Phase 2

• 1 other identifier: GV1001-PSP-CL2-011-E
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy GV1001

Outcome Measures

Primary Outcomes (33)

• Adverse Event

  Adverse Event

  12 months

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

  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

  12 months

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

  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

  12 months

• Change in Hematological tests Hemoglobin(g/dL)

  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

  12 months

• Change in Hematological tests Hematocrit(%)

  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

  12 months

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

  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

  12 months

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

  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

  12 months

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

  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

  12 months

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

  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

  12 months

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

  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

  12 months

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

  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 months

• Change in Hematochemical tests BUN(mg/dL)

  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

  12 months

• Change in Hematochemical tests Creatinine(mg/dL)

  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

  12 months

• Change in Hematochemical tests Uric acid(mg/dL)

  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

  12 months

• Change in Hematochemical tests Total bilirubin(mg/dL)

  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

  12 months

• Change in Hematochemical tests Albumin(g/dL)

  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

  12 months

• Change in Hematochemical tests Total Protein(g/dL)

  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

  12 months

• Change in Hematochemical tests ALT(U/L)

  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

  12 months

• Change in Hematochemical tests AST(U/L)

  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

  12 months

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

  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

  12 months

• Change in Hematochemical tests Alkaline phosphatase(U/L)

  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

  12 months

• Change in Hematochemical tests Glucose(mg/dL)

  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

  12 months

• Change in Hematochemical tests Total Cholesterol(mg/dL)

  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

  12 months

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

  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

  12 months

• Change in urine tests Glucose(mg/dL)

  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

  12 months

• Change in urine tests Ketones(mg/dL)

  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

  12 months

• Change in urine tests WBC(HPF)

  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

  12 months

• Change in urine tests Blood-RBC(HPF)

  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

  12 months

• Blood Pressure (mmHG)

  Change in Blood Pressure (mmHG)

  12 months

• Pulse rate(beats per min)

  Change in Pulse rate(beats per min)

  12 months

• Respiratory rate(breaths per min)

  Change in Respiratory rate(breaths per min)

  12 months

• temperature(℃)

  Change in temperature(℃)

  12 months

• EKG

  EKG result(normal or abnormal)

  12 months

Other Outcomes (6)

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

  18 months

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

  18 months

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

  18 months

Study Arms (1)

GV1001 1.12 mg

EXPERIMENTAL

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.

Drug: GV1001 Placebo; Drug: GV1001 1.12mg

Interventions

GV1001 Placebo DRUG

0.9% normal saline

Also known as: Normal saline

GV1001 1.12 mg

GV1001 1.12mg DRUG

Lyophilized peptide from hTERT

Also known as: Tertomotide 1.68mg

GV1001 1.12 mg

Eligibility Criteria

• Age: 41 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GemVax & Kael: lead

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sang Jae Kim

  GemVax & Kael

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: February 1, 2024
• Study Start: December 12, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)