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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
957
MT10109L Dose 1 will be injected into the GL area
MT10109L Dose 2 will be injected into the LCL area
MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
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
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
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
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
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
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
Number of Participants With Binding and Neutralizing Antibodies
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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