Glabellar Lines, Lateral Canthal Lines
Conditions
Brief summary
To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.
Detailed description
Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). The objective is to evaluate long term safety of MT10109L. Participants will include those who completed the global lead-in studies and meet the eligibility criteria for entering this open-label extension study. Participants who meet retreatment criteria will receive MT10109L administered in the same treatment area(s) with the same number of injections and injection sites as in their lead-in studies. The safety and efficacy data from the lead-in and this open-label extension will be summarized.
Interventions
DRUGMT10109L Dose 1
MT10109L Dose 1 will be injected into the GL area
DRUGMT10109L Dose 2
MT10109L Dose 2 will be injected into the LCL area
DRUGMT10109L Dose 1 + Dose 2
MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
Sponsors
Medy-Tox
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completion of lead-in Phase 3 study; * Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
Exclusion criteria
* Known immunization or hypersensitivity to any botulinum toxin serotype; * Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function; * Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures; * Females who are pregnant, nursing, or planning a pregnancy during the study; * Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | Baseline to Day 720 or Study Exit | The outcome reported here is the mean change in respiratory rate from baseline to study exit. |
| Number of Participants Who Experienced Any Adverse Event (AE) | Baseline to Day 720 or Study Exit | The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit. |
| Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | Baseline to Day 720 or Study exit | This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study. |
| Mean Change From Baseline in Pulse Rate (Beats Per Minute) | Baseline to Day 720 or Study Exit | The outcome reported here is the mean change in pulse rate from baseline to study exit. |
| Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | Baseline to Day 720 or Study Exit | The outcome reported here is the mean change in Systolic BP from baseline to study exit. |
| Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | Baseline to Day 720 or Study Exit | The outcome reported here is the mean change in Diastolic BP from baseline to study exit. |
| Number of Participants With Binding and Neutralizing Antibodies | Baseline to Day 720 or Study Exit | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. |
Countries
Belgium, Canada, Germany, Russia, United Kingdom, United States
Participant flow
Recruitment details
Approximately 800 participants were planned to be enrolled. A total of 957 participants were enrolled and treated, and 759 participants completed the study. There were 957 participants in the intent-to-treat (ITT) population, which were used for the efficacy of US FDA and safety analyses.
Pre-assignment details
Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006(NCT03732833) (referred to as Lead-In studies). Participants from the lead-in studies, who met the eligibility criteria, were enrolled to continue receiving additional cycles of MT10109L in their respective treatment areas (Glabellar area or Lateral Canthal Lines area).
Participants by arm
| Arm | Count |
|---|---|
| Placebo/MT10109L Dose 1 The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area. | 55 |
| Placebo/MT10109L Dose 2 The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. | 56 |
| Placebo/MT10109L Dose 1 + Dose 2 The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. | 118 |
| MT10109L Dose 1/Dose 1 The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area | 116 |
| MT10109L Dose 2/Dose 2 The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. | 108 |
| MT10109L Dose 1/Dose 1+2 The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. | 128 |
| MT10109L Dose 2/Dose 1+2 The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area | 123 |
| MT10109L Dose 1+2/Dose 1+2 The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. | 253 |
| Total | 957 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | COVID-19, Family Reasons etc. | 0 | 2 | 4 | 1 | 4 | 6 | 0 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 8 | 6 | 6 | 3 | 7 | 9 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 1 | 0 | 3 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 3 | 0 | 0 | 0 | 3 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 10 | 12 | 20 | 12 | 11 | 18 | 24 |
Baseline characteristics
| Characteristic | Placebo/MT10109L Dose 2 | Placebo/MT10109L Dose 1 + Dose 2 | MT10109L Dose 1/Dose 1 | MT10109L Dose 2/Dose 2 | MT10109L Dose 1/Dose 1+2 | MT10109L Dose 2/Dose 1+2 | Placebo/MT10109L Dose 1 | MT10109L Dose 1+2/Dose 1+2 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 8 Participants | 9 Participants | 5 Participants | 8 Participants | 10 Participants | 1 Participants | 12 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 110 Participants | 107 Participants | 103 Participants | 120 Participants | 113 Participants | 54 Participants | 241 Participants | 902 Participants |
| Age, Continuous | 46.7 years STANDARD_DEVIATION 11.75 | 48.2 years STANDARD_DEVIATION 11.68 | 46.9 years STANDARD_DEVIATION 12.17 | 47.1 years STANDARD_DEVIATION 10.34 | 47.8 years STANDARD_DEVIATION 11.24 | 48.5 years STANDARD_DEVIATION 10.53 | 47.1 years STANDARD_DEVIATION 10.18 | 47.9 years STANDARD_DEVIATION 10.8 | 47.7 years STANDARD_DEVIATION 11.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 3 Participants | 17 Participants | 19 Participants | 5 Participants | 1 Participants | 23 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 106 Participants | 113 Participants | 91 Participants | 109 Participants | 118 Participants | 54 Participants | 230 Participants | 872 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 1 Participants | 4 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 113 Participants | 112 Participants | 101 Participants | 123 Participants | 119 Participants | 53 Participants | 241 Participants | 915 Participants |
| Sex: Female, Male Female | 42 Participants | 99 Participants | 106 Participants | 87 Participants | 109 Participants | 103 Participants | 53 Participants | 227 Participants | 826 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 10 Participants | 21 Participants | 19 Participants | 20 Participants | 2 Participants | 26 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 56 | 0 / 118 | 2 / 116 | 0 / 108 | 0 / 128 | 0 / 123 | 0 / 253 |
| other Total, other adverse events | 26 / 55 | 23 / 56 | 58 / 118 | 54 / 116 | 45 / 108 | 50 / 128 | 60 / 123 | 128 / 253 |
| serious Total, serious adverse events | 3 / 55 | 1 / 56 | 10 / 118 | 8 / 116 | 9 / 108 | 7 / 128 | 13 / 123 | 13 / 253 |
Outcome results
Primary
Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)
The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Time frame: Baseline to Day 720 or Study Exit
Population: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/MT10109L Dose 1 | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | 1.1 mmHg | Standard Deviation 11.3 |
| Placebo/MT10109L Dose 2 | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | -0.6 mmHg | Standard Deviation 11.75 |
| Placebo/MT10109L Dose 1 + Dose 2 | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | 1.3 mmHg | Standard Deviation 9.61 |
| MT10109L Dose 1/Dose 1 | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | 1.5 mmHg | Standard Deviation 11.68 |
| MT10109L Dose 2/Dose 2 | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | 0.7 mmHg | Standard Deviation 7.57 |
| MT10109L Dose 1/Dose 1+2 | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | 0.0 mmHg | Standard Deviation 10.62 |
| MT10109L Dose 2/Dose 1+2 | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | 2.3 mmHg | Standard Deviation 9.53 |
| MT10109L Dose 1+2/Dose 1+2 | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | -0.3 mmHg | Standard Deviation 9.46 |
Primary
Mean Change From Baseline in Pulse Rate (Beats Per Minute)
The outcome reported here is the mean change in pulse rate from baseline to study exit.
Time frame: Baseline to Day 720 or Study Exit
Population: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/MT10109L Dose 1 | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | 3.2 beats/min | Standard Deviation 15.01 |
| Placebo/MT10109L Dose 2 | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | -2.2 beats/min | Standard Deviation 13.35 |
| Placebo/MT10109L Dose 1 + Dose 2 | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | -1.2 beats/min | Standard Deviation 10.95 |
| MT10109L Dose 1/Dose 1 | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | 2.0 beats/min | Standard Deviation 12.77 |
| MT10109L Dose 2/Dose 2 | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | 0.6 beats/min | Standard Deviation 11.58 |
| MT10109L Dose 1/Dose 1+2 | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | 0.7 beats/min | Standard Deviation 10.97 |
| MT10109L Dose 2/Dose 1+2 | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | 3.0 beats/min | Standard Deviation 10.34 |
| MT10109L Dose 1+2/Dose 1+2 | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | 1.0 beats/min | Standard Deviation 8.93 |
Primary
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)
The outcome reported here is the mean change in respiratory rate from baseline to study exit.
Time frame: Baseline to Day 720 or Study Exit
Population: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/MT10109L Dose 1 | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | 0.3 breaths/min | Standard Deviation 2.09 |
| Placebo/MT10109L Dose 2 | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | 0.6 breaths/min | Standard Deviation 2.15 |
| Placebo/MT10109L Dose 1 + Dose 2 | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | -0.5 breaths/min | Standard Deviation 1.92 |
| MT10109L Dose 1/Dose 1 | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | 0.2 breaths/min | Standard Deviation 2.78 |
| MT10109L Dose 2/Dose 2 | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | 0.5 breaths/min | Standard Deviation 1.94 |
| MT10109L Dose 1/Dose 1+2 | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | -0.4 breaths/min | Standard Deviation 2.29 |
| MT10109L Dose 2/Dose 1+2 | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | 0.4 breaths/min | Standard Deviation 2.21 |
| MT10109L Dose 1+2/Dose 1+2 | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | -0.1 breaths/min | Standard Deviation 2.3 |
Primary
Mean Change From Baseline in Systolic Blood Pressure (mm Hg)
The outcome reported here is the mean change in Systolic BP from baseline to study exit.
Time frame: Baseline to Day 720 or Study Exit
Population: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/MT10109L Dose 1 | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | 1.4 mmHg | Standard Deviation 12.59 |
| Placebo/MT10109L Dose 2 | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | -1.9 mmHg | Standard Deviation 10.44 |
| Placebo/MT10109L Dose 1 + Dose 2 | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | 1.9 mmHg | Standard Deviation 14.44 |
| MT10109L Dose 1/Dose 1 | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | 0.6 mmHg | Standard Deviation 16.72 |
| MT10109L Dose 2/Dose 2 | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | 1.1 mmHg | Standard Deviation 13.84 |
| MT10109L Dose 1/Dose 1+2 | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | 1.8 mmHg | Standard Deviation 15.24 |
| MT10109L Dose 2/Dose 1+2 | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | 1.4 mmHg | Standard Deviation 14.17 |
| MT10109L Dose 1+2/Dose 1+2 | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | -0.4 mmHg | Standard Deviation 13.83 |
Primary
Number of Participants Who Experienced Any Adverse Event (AE)
The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.
Time frame: Baseline to Day 720 or Study Exit
Population: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/MT10109L Dose 1 | Number of Participants Who Experienced Any Adverse Event (AE) | 39 Participants |
| Placebo/MT10109L Dose 2 | Number of Participants Who Experienced Any Adverse Event (AE) | 39 Participants |
| Placebo/MT10109L Dose 1 + Dose 2 | Number of Participants Who Experienced Any Adverse Event (AE) | 80 Participants |
| MT10109L Dose 1/Dose 1 | Number of Participants Who Experienced Any Adverse Event (AE) | 89 Participants |
| MT10109L Dose 2/Dose 2 | Number of Participants Who Experienced Any Adverse Event (AE) | 74 Participants |
| MT10109L Dose 1/Dose 1+2 | Number of Participants Who Experienced Any Adverse Event (AE) | 80 Participants |
| MT10109L Dose 2/Dose 1+2 | Number of Participants Who Experienced Any Adverse Event (AE) | 89 Participants |
| MT10109L Dose 1+2/Dose 1+2 | Number of Participants Who Experienced Any Adverse Event (AE) | 183 Participants |
Primary
Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)
This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study.
Time frame: Baseline to Day 720 or Study exit
Population: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/MT10109L Dose 1 | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | 18 Participants |
| Placebo/MT10109L Dose 2 | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | 4 Participants |
| Placebo/MT10109L Dose 1 + Dose 2 | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | 31 Participants |
| MT10109L Dose 1/Dose 1 | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | 34 Participants |
| MT10109L Dose 2/Dose 2 | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | 11 Participants |
| MT10109L Dose 1/Dose 1+2 | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | 22 Participants |
| MT10109L Dose 2/Dose 1+2 | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | 42 Participants |
| MT10109L Dose 1+2/Dose 1+2 | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | 73 Participants |
Primary
Number of Participants With Binding and Neutralizing Antibodies
Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.
Time frame: Baseline to Day 720 or Study Exit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/MT10109L Dose 1 | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
| Placebo/MT10109L Dose 2 | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
| Placebo/MT10109L Dose 1 + Dose 2 | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
| MT10109L Dose 1/Dose 1 | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
| MT10109L Dose 2/Dose 2 | Number of Participants With Binding and Neutralizing Antibodies | 2 Participants |
| MT10109L Dose 1/Dose 1+2 | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
| MT10109L Dose 2/Dose 1+2 | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
| MT10109L Dose 1+2/Dose 1+2 | Number of Participants With Binding and Neutralizing Antibodies | 1 Participants |