This is a multicenter, open-label study designed to determine the long-term safety of ASC40 (Denifanstat) tablets in patients with moderate to severe acne vulgaris enrolled in the ASC40-303 Phase III study. All subjects are eligible for study eligibility screening after enrollment in ASC40-303 Phase III study, and all eligible subjects with moderate to severe acne vulgaris will receive ASC40 (Denifanstat) tablets after signing informed consent. The investigational drug will be administered orally once daily (QD) for up to 40 weeks. There will be a total of 7 visits for screening and follow-up. The tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
240
ASC40 tablets orally once daily
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Number and percentage of subjects with treatment emergent adverse events (TEAE)
The number and percentage of all subjects with treatment emergent adverse events (TEAE) from the first dose to 40 weeks of treatment.
Time frame: From the first dose to 40 weeks of treatment.
Number and percentage of subjects with serious adverse event (SAE).
Number and percentage of subjects with serious adverse event (SAE) from the first dose to 40 weeks of treatment.
Time frame: From the first dose to 40 weeks of treatment.
Number and percentage of subjects who discontinued due to adverse events.
Number and percentage of subjects who discontinued due to adverse events from the first dose to 40 weeks of treatment.
Time frame: From the first dose to 40 weeks of treatment.
At the end of the visit, the number of people whose IGA rating had decreased by at least 2 points from the baseline period of the study.
At the end of the visit, the number of subjects whose IGA rating had decreased by at least 2 points from the baseline period of the study.
Time frame: up to 40 weeks.
At the end of the visit, the number of subjects with an IGA score of 3 or higher at baseline dropped to an IGA score of 0 or 1.
At the end of the visit, the number of subjects with an IGA score of 3 or higher at baseline dropped to an IGA score of 0 or 1 among all subjects.
Time frame: up to 40 weeks.
Percentage change in total skin lesion count at the end of the visit compared to the baseline period of the study.
Percentage change in total skin lesion count at the end of the visit compared to the baseline period of the study.
Time frame: up to 40 weeks.
Percentage change in total inflammatory skin lesion count at the end of the visit compared to the baseline period of the study.
Percentage change in total inflammatory skin lesion count for all subjects at the end of the visit compared to the baseline period of the study.
Time frame: up to 40 weeks.
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