A Study to Evaluate Safety of ASC40 Tablets in Patients With Moderate to Severe Acne Vulgaris

An Open, Multicenter, Phase III Extension Clinical Trial to Evaluate the Long-term Safety of ASC40 (Denifanstat) Tablets in Patients With Moderate to Severe Acne Vulgaris

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 Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: ASC40

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Huashan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants who have successfully completed a 12-week Phase III study of ASC40-303;
• Have fully understood this research and voluntarily signed the informed consent;
• The fertile male and female subjects of reproductive age agreed to use effective contraception from the time they signed the informed consent until 3 months after the final administration of the investigationa drug;
• Subjects are willing and able to complete the study, understand and comply with the study requirements, comply with the study requirements restrictions and related education, use the investigational drug as prescribed by the physician, and follow up according to the study schedule.

Exclusion Criteria:

• Discontinue participation in the ASC40-303 Phase III study for any reason;
• Are receiving/planning to receive any systemic acne medications, systemic retinoids, systemic corticosteroids, or any androgen/antiandrogen therapy (e.g., testosterone, spironolactone);
• Pregnant, nursing, or planning a pregnancy during the study period;
• Have major complications (including clinically significant abnormalities in clinical laboratory tests), mental disorders, or other factors deemed unsuitable for study participation by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASC40 50mg; ASC40 50mg, up to 40 weeks of treatment.	Drug: ASC40; ASC40 tablets orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From the first dose to 40 weeks of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	up to 40 weeks.

Collaborators and Investigators

• Sponsor: Ascletis Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Actual): November 12, 2025
• Study Completion (Actual): November 12, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Acne; ASC40
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris
• Other Study ID Numbers: ASC40-304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No