Trial Outcomes & Findings for To Evaluate Effectiveness and Safety of GP0109 for Jawline Definition (NCT NCT05110287)
NCT ID: NCT05110287
Last Updated: 2026-05-18
Results Overview
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as a participant having at least a 1-grade improvement from baseline on both jawlines concurrently.
Recruitment status
COMPLETED
Target enrollment
224 participants
Primary outcome timeframe
At Month 3
Results posted on
2026-05-18
Participant Flow
This study was conducted at 15 investigative sites in the United States from 15 November 2021 to 23 October 2024.
A total of 245 participants were screened for the study, of which 21 were screen failures. Of the 224 randomized participants, 56 were randomly assigned to the no treatment group and 168 were randomly assigned to receive GP0109 injection at baseline stratified by injection tool (needle, cannula and both needle and cannula combined) and Fitzpatrick skin type (FST) group (I-III, IV and V-VI).
Participant milestones
| Measure |
Group 1: No Treatment Control Group
Participants received no treatment at baseline. At Month 12, participants were offered to receive optional treatment with GP0109.
|
Group 2: Treatment With GP0109
Participants received GP0109 injection in the jawline at Day 1 and one optional touch-up treatment after 1 month of initial treatment. At Month 12, participants were offered to receive an additional optional treatment with GP0109.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
168
|
|
Overall Study
Treated
|
47
|
167
|
|
Overall Study
Re-treated at Month 12
|
0
|
100
|
|
Overall Study
COMPLETED
|
49
|
133
|
|
Overall Study
NOT COMPLETED
|
7
|
35
|
Reasons for withdrawal
| Measure |
Group 1: No Treatment Control Group
Participants received no treatment at baseline. At Month 12, participants were offered to receive optional treatment with GP0109.
|
Group 2: Treatment With GP0109
Participants received GP0109 injection in the jawline at Day 1 and one optional touch-up treatment after 1 month of initial treatment. At Month 12, participants were offered to receive an additional optional treatment with GP0109.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
17
|
|
Overall Study
Lost to Follow-up
|
2
|
14
|
|
Overall Study
Medical Reason
|
0
|
3
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
To Evaluate Effectiveness and Safety of GP0109 for Jawline Definition
Baseline characteristics by cohort
| Measure |
Group 1: No Treatment Control Group
n=56 Participants
Participants received no treatment at baseline. At Month 12, participants were offered to receive optional treatment with GP0109.
|
Group 2: Treatment With GP0109
n=168 Participants
Participants received GP0109 injection in the jawline at Day 1 and one optional touch-up treatment after 1 month of initial treatment. At Month 12, participants were offered to receive an additional optional treatment with GP0109.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
9 Participants
n=11 Participants
|
16 Participants
n=9 Participants
|
25 Participants
n=20 Participants
|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 13.06 • n=11 Participants
|
52.8 years
STANDARD_DEVIATION 12.36 • n=9 Participants
|
53.0 years
STANDARD_DEVIATION 12.51 • n=20 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=11 Participants
|
152 Participants
n=9 Participants
|
199 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=11 Participants
|
39 Participants
n=9 Participants
|
54 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=11 Participants
|
129 Participants
n=9 Participants
|
170 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
15 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=11 Participants
|
140 Participants
n=9 Participants
|
186 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
12 Participants
n=9 Participants
|
12 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The Intention-to-treat (ITT) population includes all participants who were randomized and analyzed according to the randomization scheme. All effectiveness variables were analyzed based on the ITT population. The modified Baseline Observation Carried Forward (BOCF) method was used.
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as a participant having at least a 1-grade improvement from baseline on both jawlines concurrently.
Outcome measures
| Measure |
Group 1: No Treatment Control Group
n=56 Participants
Participants received no treatment at baseline. At Month 12, participants were offered to receive optional treatment with GP0109.
|
Group 2: Treatment With GP0109
n=168 Participants
Participants received GP0109 injection in the jawline at Day 1 and one optional touch-up treatment after 1 month of initial treatment. At Month 12, participants were offered to receive an additional optional treatment with GP0109.
|
|---|---|---|
|
Percentage of Responders Based on Blinded Evaluators' Live Assessment of the Galderma Jawline Scale (GJS)
|
14.3 percentage of participants
|
85.1 percentage of participants
|
Adverse Events
Group 1: No Treatment Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Initial Treatment With GP0109
Serious events: 9 serious events
Other events: 12 other events
Deaths: 1 deaths
Group 3: Re-treatment With GP0109
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: No Treatment Control Group
n=56 participants at risk
Participants in this group received no treatment at baseline of the study. The events were unrelated to both study product and injection procedure.
|
Group 2: Initial Treatment With GP0109
n=214 participants at risk
Participants who received initial treatment with GP0109 injection at Day 1 and one optional touch-up treatment at 1 month after the initial treatment were included. Participants randomized to no treatment at baseline and received initial GP0109 treatment at Month 12 were also included in this arm.
|
Group 3: Re-treatment With GP0109
n=100 participants at risk
Participants received re-treatment with GP0109 after Month 12 of the study.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
1.0%
1/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.47%
1/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
0.00%
0/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
Other adverse events
| Measure |
Group 1: No Treatment Control Group
n=56 participants at risk
Participants in this group received no treatment at baseline of the study. The events were unrelated to both study product and injection procedure.
|
Group 2: Initial Treatment With GP0109
n=214 participants at risk
Participants who received initial treatment with GP0109 injection at Day 1 and one optional touch-up treatment at 1 month after the initial treatment were included. Participants randomized to no treatment at baseline and received initial GP0109 treatment at Month 12 were also included in this arm.
|
Group 3: Re-treatment With GP0109
n=100 participants at risk
Participants received re-treatment with GP0109 after Month 12 of the study.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/56 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
5.6%
12/214 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
5.0%
5/100 • For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place