MT10109L in the Treatment of Glabellar Lines

The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.

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.

Change from baseline at study exit.

Time frame: Baseline to Study Exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study Exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study Exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study Exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study Exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study Exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study Exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.

Change from baseline at study exit.

Time frame: Baseline to Study exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline 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: Up to Study Exit (Day 360 or early exit)

Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention.

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 from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).

Population: All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.

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 (i.e., 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-gradeimprovement from baseline in GL severity at maximum frown at Day 30 of double-blind period according to investigator assessments using the Facial Wrinkle Scale (FWS). This corresponds to the responders for Outcome 2. 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 wasdefined as all participants who were randomized. Analyses of the secondary efficacy variables wereperformed 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 of double-blind period. 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 of double-blind period. 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.