Back to resultsGV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)
Primary Purpose
Progressive Supranuclear Palsy
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GV1001 Placebo
GV1001 0.56mg
GV1001 1.12mg
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring Progressive Supranuclear Palsy, GV1001
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Sites / Locations
- Seoul National University Bundang Hospital
- Kyung Hee University Hospital
- Samsung Medical CenterRecruiting
- Seoul Metropolitan Government Seoul National University Boramae Medical CenterRecruiting
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
GV1001 0.56 mg
GV1001 1.12 mg
Arm Description
Placebo 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 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 SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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) and 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.
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) and 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.
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) and 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.
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 12 weeks (3 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.
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 12 weeks (3 months) and 24 weeks (6 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05819658
Brief Title
GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GemVax & Kael
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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 2 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy
Keywords
Progressive Supranuclear Palsy, GV1001
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
Arm Title
GV1001 0.56 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
GV1001 1.12 mg
Arm Type
Experimental
Arm Description
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
Intervention Type
Drug
Intervention Name(s)
GV1001 Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
0.9% normal saline
Intervention Type
Drug
Intervention Name(s)
GV1001 0.56mg
Other Intervention Name(s)
Tertomotide 0.84mg
Intervention Description
Lyophilized peptide from hTERT
Intervention Type
Drug
Intervention Name(s)
GV1001 1.12mg
Other Intervention Name(s)
Tertomotide 1.68mg
Intervention Description
Lyophilized peptide from hTERT
Primary Outcome Measure Information:
Title
Change from the baseline in the total score of PSP-rating scale
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from the baseline in the total score of PSP-rating scale
Description
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.
Time Frame
3 months
Title
Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK)
Description
Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 12 weeks (3 months) and 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.
Time Frame
3 months and 6 months
Title
Change from the baseline in the Korean Frontal Assessment Battery (K-FAB)
Description
Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 12 weeks (3 months) and 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.
Time Frame
3 months and 6 months
Title
Change from the baseline in the England & Schwab Activity of Daily Living (ES ADL) scale
Description
Change from the baseline in the England & Schwab Activity of Daily Living (ES ADL) scale after 12 weeks (3 months) and 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.
Time Frame
3 months and 6 months
Title
Change from the baseline in the score of each domain of the PSP-rating scale
Description
Change from the baseline in the score of each domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 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.
Time Frame
3 months and 6 months
Title
Change from the baseline in the score of each item of the PSP-rating scale
Description
Change from the baseline in the score of each item of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) and 24 weeks (6 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.
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mino Moon
Phone
+82 70 8633 7102
Email
clinical@gemvax.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Jae Kim
Organizational Affiliation
GemVax & Kael
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Min Kim
First Name & Middle Initial & Last Name & Degree
Jong-Min Kim
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Beom Ahn
First Name & Middle Initial & Last Name & Degree
Tae-Beom Ahn
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Hyeon Ahn
First Name & Middle Initial & Last Name & Degree
Jong Hyeon Ahn
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee-Young Lee
First Name & Middle Initial & Last Name & Degree
Jee-Young Lee
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han-Joon Kim
First Name & Middle Initial & Last Name & Degree
Han-Joon Kim
First Name & Middle Initial & Last Name & Degree
Beom Seok Jeon
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)
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