MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)

The outcome measured is the percentage of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) according to investigator and participant assessments of Glabellar Lines (GL) severity at maximum frown at Day 30. The investigator and participant evaluates the participant's GL severity using a Facial Wrinkle Scale With Photonumeric Guide (FWS) at maximum frown on Day 30. The scale ranges from (0 to 3) where 0=none and 3 = severe.

Time frame: Day 30

Population: All primary and secondary efficacy analyses endpoints were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint. Analyses of the secondary efficacy variables were performed using observed data.

Changes in vital signs: Diastolic BP

Time frame: Baseline to Day 360 (Study exit)

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Change from baseline for ECG safety population - Heart Rate

Time frame: Baseline to Day 360

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Change from baseline for ECG safety population - PR Interval

Time frame: Baseline to Day 360

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Change from baseline for ECG safety population - QRS duration

Time frame: Baseline to Day 360

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Change from baseline for ECG safety population - QTcB interval

Time frame: Baseline to Day 360

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Change from baseline for ECG safety population - QTcF interval

Time frame: Baseline to Day 360

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Change from baseline for ECG safety population - QT interval

Time frame: Baseline to Day 360

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Change from baseline for ECG safety population - RR interval

Time frame: Baseline to Day 360

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Changes in vital signs: Pulse Rate

Time frame: Baseline to Day 360 (Study exit)

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Changes in vital signs: Respiratory Rate

Time frame: Baseline to Day 360 (Study exit)

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

Changes in vital signs: Systolic BP

Time frame: Baseline to Day 360 (Study exit)

Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.

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: Day 360

Population: All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.

This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.

Time frame: The time frame for AEs is after the first dose (Day 1) and up to 30 days after their last visit or study exit (Day 360 unless participant exits earlier)

Population: All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.

The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (ie, return to moderate or severe GL severity at maximum frown using the FWS).

Time frame: Day 1 (first treatment) to Day 180

Population: The analysis population for this outcome includes the participants who achieved a rating of ≥ 2-grade improvement from baseline in GL severity at maximum frown at Day 30 according to investigator assessments using the Facial Wrinkle Scale (FWS). This corresponds to the responders for Outcome 3. NA means no participant from the group achieved a rating of ≥ 2-grade improvement from baseline in GL severity. Note: Analyses of the secondary efficacy variables were performed using observed data.

The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.

Time frame: Day 60

Population: All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data

The percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.

Time frame: Day 30

Population: All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.

The outcome was measured Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30 The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.

Time frame: Day 30

Population: All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.