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

Progressive Supranuclear Palsy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235775
• Other study ID #: GV1001-PSP-CL2-011-E
• Status: Recruiting
• Phase: Phase 2
• Start date: December 12, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: December 2023
• Source: GemVax & Kael
• Contact: Mino Moon
• Phone: +82 70 4738 9726
• Email: clinical[@]gemvax.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 30, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• GV1001 Placebo
0.9% normal saline
• GV1001 1.12mg
Lyophilized peptide from hTERT

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GemVax & Kael

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 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.	18 months
Other	Change from the baseline in the score of each domain of the PSP-rating scale	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.	18 months
Other	Change from the baseline in the score of each item of the PSP-rating scale	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.	18 months
Other	Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK)	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.	18 months
Other	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 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.	18 months
Other	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 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.	18 months
Primary	Adverse Event	Adverse Event	12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Hematochemical tests ?-GTP(U/L)	?-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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Blood Pressure (mmHG)	Change in Blood Pressure (mmHG)	12 months
Primary	Pulse rate(beats per min)	Change in Pulse rate(beats per min)	12 months
Primary	Respiratory rate(breaths per min)	Change in Respiratory rate(breaths per min)	12 months
Primary	temperature(?)	Change in temperature(?)	12 months
Primary	EKG	EKG result(normal or abnormal)	12 months