Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

Study Overview
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Brief Summary
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This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.

Official Title
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Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: MBA-P01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who completed the phase III trial (MT14-KR20GBL309) Patients who were capable of understanding and complying with the protocol and have signed the informed consent form voluntarily Exclusion Criteria: Patients who have received other procedures which may affect glabellar lines within 6 months (except of MBA-P01 or BOTOX® treated in phase III trial, MT14-KR20GBL309) Female patients who are pregnant or lactating. Female patients of childbearing age who have a plan to get pregnant during the study period. Patient who do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.) Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening Patients who are not eligible for this study based on the judgment of an investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBA-P01<br>MBA-P01 will be injected into GL: | Drug: MBA-P01<br>* MBA-P01 will be injected into the Glabellar line.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and adverse event of special interest (AESI), when MBA-P01 is administered in repeated treatments. |  | Through study completion, an average of 1 year | 
| Incidence rate of TEAE, ADR, SAE and AESI of each cycle |  | Through each cycle, an average of 3 months | 
| The change of laboratory test and vital sign |  | Through study completion, an average of 1 year | 
| The result of anti-drug-andibodies (ADA) and neutralizing antibodies |  | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle | Proportion of paricipants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity* as assessed by investigator *GL severity: 0=none, 1=mild, 2=moderate, 3=severe | at week 4, week 8 and 12 of each cycle | 
| Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle | Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity* as assessed by investigator *GL severity: 0=none, 1=mild, 2=moderate, 3=severe | at week 4, week 8 and 12 of each cycle | 
| Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle | Proportion of participants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity* as assessed by participant *GL severity: 0=none, 1=mild, 2=moderate, 3=severe | at week 4, week 8 and 12 of each cycle | 
| Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle | Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity* as assessed by participant *GL severity: 0=none, 1=mild, 2=moderate, 3=severe | at week 4, week 8 and 12 of each cycle | 
| Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle | Participant evaluate the level of safisfaction by 7-grade score | at week 4, week 8 and 12 of each cycle | 
| Time to retreatment |  | Through study completion, an average of 1 year |