Trial Outcomes & Findings for GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP) (NCT NCT05819658)
NCT ID: NCT05819658
Last Updated: 2026-02-10
Results Overview
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.
COMPLETED
PHASE2
78 participants
24 weeks(6 months)
2026-02-10
Participant Flow
Participant milestones
| Measure |
Placebo
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
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
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
28
|
|
Overall Study
COMPLETED
|
22
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
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
n=25 Participants
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
n=28 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
11 Participants
n=25 Participants
|
9 Participants
n=25 Participants
|
6 Participants
n=28 Participants
|
26 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=25 Participants
|
16 Participants
n=25 Participants
|
22 Participants
n=28 Participants
|
52 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
28 Participants
n=28 Participants
|
78 Participants
n=78 Participants
|
|
PSP type
PSP-Richardson type
|
18 Participants
n=25 Participants
|
16 Participants
n=25 Participants
|
21 Participants
n=28 Participants
|
55 Participants
n=78 Participants
|
|
PSP type
PSP Parkinsonian type
|
7 Participants
n=25 Participants
|
9 Participants
n=25 Participants
|
7 Participants
n=28 Participants
|
23 Participants
n=78 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=78 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=25 Participants
|
7 Participants
n=25 Participants
|
3 Participants
n=28 Participants
|
16 Participants
n=78 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=25 Participants
|
18 Participants
n=25 Participants
|
25 Participants
n=28 Participants
|
62 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
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.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Total Score of PSP-rating Scale
|
2.14 scores on a scale
Standard Deviation 1.78
|
6.46 scores on a scale
Standard Deviation 1.64
|
4.10 scores on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: 12 Weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
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.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Total Score of PSP-rating Scale
|
-0.47 scores on a scale
Standard Deviation 1.65
|
2.75 scores on a scale
Standard Deviation 1.55
|
1.42 scores on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: 12 weeks (3 Months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)
|
0.93 scores on a scale
Standard Deviation 0.64
|
0.26 scores on a scale
Standard Deviation 0.60
|
0.25 scores on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 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.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)
|
0.35 scores on a scale
Standard Deviation 0.78
|
-1.46 scores on a scale
Standard Deviation 0.71
|
0.29 scores on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)
|
-1.06 scores on a scale
Standard Deviation 0.53
|
-1.42 scores on a scale
Standard Deviation 0.49
|
-0.29 scores on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 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.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)
|
-0.89 scores on a scale
Standard Deviation 0.59
|
-1.42 scores on a scale
Standard Deviation 0.54
|
-0.20 scores on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the England \& Schwab Activity of Daily Living (ES ADL) scale after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale
|
-2.70 scores on a scale
Standard Deviation 3.02
|
-7.12 scores on a scale
Standard Deviation 2.85
|
-2.18 scores on a scale
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the England \& Schwab Activity of Daily Living (ES ADL) scale after 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.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale
|
-8.35 scores on a scale
Standard Deviation 3.23
|
-17.12 scores on a scale
Standard Deviation 2.99
|
-9.45 scores on a scale
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the score of \[History\] domain of the 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 24 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)
|
-0.17 scores on a scale
Standard Deviation 0.59
|
0.41 scores on a scale
Standard Deviation 0.55
|
-0.26 scores on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the score of \[History\] domain of the 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 24 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)
|
0.90 scores on a scale
Standard Deviation 0.70
|
1.36 scores on a scale
Standard Deviation 0.64
|
0.42 scores on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the score of \[Mentation\] domain of the 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 16 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)
|
-0.01 scores on a scale
Standard Deviation 0.41
|
0.23 scores on a scale
Standard Deviation 0.39
|
0.31 scores on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the score of \[Mentation\] domain of the 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 16 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)
|
-0.07 scores on a scale
Standard Deviation 0.43
|
0.66 scores on a scale
Standard Deviation 0.40
|
0.26 scores on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the score of \[Bulbar\] domain of the 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 8 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)
|
0.11 scores on a scale
Standard Deviation 0.25
|
-0.08 scores on a scale
Standard Deviation 0.24
|
0.35 scores on a scale
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the score of \[Bulbar\] domain of the 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 8 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)
|
0.04 scores on a scale
Standard Deviation 0.28
|
0.68 scores on a scale
Standard Deviation 0.26
|
0.49 scores on a scale
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the score of \[Ocular Motor\] domain of the 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 16 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)
|
0.08 scores on a scale
Standard Deviation 0.49
|
0.86 scores on a scale
Standard Deviation 0.46
|
-0.05 scores on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the score of \[Ocular Motor\] domain of the 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 16 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)
|
0.25 scores on a scale
Standard Deviation 0.46
|
1.30 scores on a scale
Standard Deviation 0.43
|
1.36 scores on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the score of \[Limb Motor\] domain of the 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 16 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)
|
-0.26 scores on a scale
Standard Deviation 0.38
|
0.02 scores on a scale
Standard Deviation 0.36
|
0.27 scores on a scale
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the score of \[Limb Motor\] domain of the 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 16 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)
|
-0.07 scores on a scale
Standard Deviation 0.55
|
0.51 scores on a scale
Standard Deviation 0.50
|
0.45 scores on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the score of \[Midline/Gait\] domain of the 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 20 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)
|
-0.08 scores on a scale
Standard Deviation 0.49
|
1.19 scores on a scale
Standard Deviation 0.46
|
0.26 scores on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the score of \[Midline/Gait\] domain of the 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 20 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)
|
1.28 scores on a scale
Standard Deviation 0.59
|
1.79 scores on a scale
Standard Deviation 0.54
|
0.58 scores on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 12 weeks(3 months)Population: Participants who completed 12 weeks (3 months) were included.
Change from the baseline in the score of each item \[Item 12\_Dysarthria\] of the PSP-rating scale after 12 weeks (3 months) of investigational product administration. Only the analysis result for Item no.12 out of a total of 28 items is described. The possible total scores range from 0 to 4 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=22 Participants
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
n=26 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)
|
0.13 scores on a scale
Standard Deviation 0.15
|
0.06 scores on a scale
Standard Deviation 0.14
|
0.21 scores on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 24 weeks(6 months)Population: Participants who completed 24 weeks (6 months) were included.
Change from the baseline in the score of each item \[Item 12\_Dysarthria\] of the PSP-rating scale after 24 weeks (6 months) of investigational product administration. Only the analysis result for Item no.12 out of a total of 28 items is described. The possible total scores range from 0 to 4 with a higher score indicating severely impaired cognitive function.
Outcome measures
| Measure |
GV1001 0.56 mg
n=20 Participants
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
n=25 Participants
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
Placebo
n=22 Participants
Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)
|
0.01 scores on a scale
Standard Deviation 0.15
|
0.44 scores on a scale
Standard Deviation 0.14
|
0.44 scores on a scale
Standard Deviation 0.14
|
Adverse Events
Placebo
GV1001 0.56 mg
GV1001 1.12 mg
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
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
n=24 participants at risk
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
n=28 participants at risk
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia aspiration
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
3.6%
1/28 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Infections and infestations
Tuberculous pleurisy
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
3.6%
1/28 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
3.6%
1/28 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
3.6%
1/28 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
3.6%
1/28 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Gastrointestinal disorders
Gastric ulcer
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
3.6%
1/28 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
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
n=24 participants at risk
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
n=28 participants at risk
GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Skin laceration
|
8.3%
2/24 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
8.3%
2/24 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
8.3%
2/24 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
General disorders
Injection site erythema
|
8.3%
2/24 • Number of events 11 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
4.2%
1/24 • Number of events 4 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
10.7%
3/28 • Number of events 9 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
General disorders
Chest pain
|
12.5%
3/24 • Number of events 3 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
General disorders
Pyrexia
|
8.3%
2/24 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
3.6%
1/28 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
12.5%
3/24 • Number of events 3 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
7.1%
2/28 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Gastrointestinal disorders
Gastric ulcer
|
8.3%
2/24 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
7.1%
2/28 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
8.3%
2/24 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
8.3%
2/24 • Number of events 2 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
0.00%
0/28 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
8.3%
2/24 • Number of events 3 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
3.6%
1/28 • Number of events 1 • From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
|
Additional Information
Hyuck Lee, Clinical Research Manager
GemVax & Kael
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place