Clinical trial NCT06235775: Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Progressive Supranuclear Palsy
Keywords: Progressive Supranuclear Palsy GV1001
Lead sponsor: GemVax & Kael
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 67
Sex: ALL
Minimum age (years): 41
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Event
timeFrame: 12 months
measure: Change in Hematological tests WBC(10^3/µl)
timeFrame: 12 months
measure: Change in Hematological tests RBC(10^6/µl)
timeFrame: 12 months
measure: Change in Hematological tests Hemoglobin(g/dL)
timeFrame: 12 months
measure: Change in Hematological tests Hematocrit(%)
timeFrame: 12 months
measure: Change in Hematological tests Platelets count(10^3/µl)
timeFrame: 12 months
measure: Change in Hematological tests WBC differential count (Neutrophils(%))
timeFrame: 12 months
measure: Change in Hematological tests WBC differential count( Lymphocytes(%))
timeFrame: 12 months
measure: Change in Hematological tests WBC differential count( Monocytes(%))
timeFrame: 12 months
measure: Change in Hematological tests WBC differential count(Eosinophils(%))
timeFrame: 12 months
measure: Change in Hematological tests WBC differential count(Basophils(%))
timeFrame: 12 months
measure: Change in Hematochemical tests BUN(mg/dL)
timeFrame: 12 months
measure: Change in Hematochemical tests Creatinine(mg/dL)
timeFrame: 12 months
measure: Change in Hematochemical tests Uric acid(mg/dL)
timeFrame: 12 months
measure: Change in Hematochemical tests Total bilirubin(mg/dL)
timeFrame: 12 months
measure: Change in Hematochemical tests Albumin(g/dL)
timeFrame: 12 months
measure: Change in Hematochemical tests Total Protein(g/dL)
timeFrame: 12 months
measure: Change in Hematochemical tests ALT(U/L)
timeFrame: 12 months
measure: Change in Hematochemical tests AST(U/L)
timeFrame: 12 months
measure: Change in Hematochemical tests γ-GTP(U/L)
timeFrame: 12 months
measure: Change in Hematochemical tests Alkaline phosphatase(U/L)
timeFrame: 12 months
measure: Change in Hematochemical tests Glucose(mg/dL)
timeFrame: 12 months
measure: Change in Hematochemical tests Total Cholesterol(mg/dL)
timeFrame: 12 months
measure: Change in urine tests Protein-Albumin(mg/dL)
timeFrame: 12 months
measure: Change in urine tests Glucose(mg/dL)
timeFrame: 12 months
measure: Change in urine tests Ketones(mg/dL)
timeFrame: 12 months
measure: Change in urine tests WBC(HPF)
timeFrame: 12 months
measure: Change in urine tests Blood-RBC(HPF)
timeFrame: 12 months
measure: Blood Pressure (mmHG)
timeFrame: 12 months
measure: Pulse rate(beats per min)
timeFrame: 12 months
measure: Respiratory rate(breaths per min)
timeFrame: 12 months
measure: temperature(℃)
timeFrame: 12 months
measure: EKG
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Change from the baseline in the total score of PSP-rating scale
timeFrame: 18 months
measure: Change from the baseline in the score of each domain of the PSP-rating scale
timeFrame: 18 months
measure: Change from the baseline in the score of each item of the PSP-rating scale
timeFrame: 18 months
measure: Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK)
timeFrame: 18 months
measure: Change from the baseline in the Korean Frontal Assessment Battery (K-FAB)
timeFrame: 18 months
measure: Change from the baseline in the England & Schwab Activity of Daily Living (ES ADL) scale
timeFrame: 18 months
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: GemVax & Kael
name: Sang Jae Kim
role: STUDY_CHAIR
References: