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NCT Number: NCT06248008

A Study to Evaluate Safety of ASC40 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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC40

Drug

ASC40 tablets orally once daily

Primary outcomes

  1. Number and percentage of subjects with treatment emergent adverse events (TEAE)

    Time frame: From the first dose to 40 weeks of treatment.

    The number and percentage of all subjects with treatment emergent adverse events (TEAE) from the first dose to 40 weeks of treatment.

  2. Number and percentage of subjects with serious adverse event (SAE).

    Time frame: From the first dose to 40 weeks of treatment.

    Number and percentage of subjects with serious adverse event (SAE) from the first dose to 40 weeks of treatment.

  3. Number and percentage of subjects who discontinued due to adverse events.

    Time frame: From the first dose to 40 weeks of treatment.

    Number and percentage of subjects who discontinued due to adverse events from the first dose to 40 weeks of treatment.

Secondary outcomes

  1. 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.

    Time frame: up to 40 weeks.

    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.

  2. 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.

    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 among all subjects.

  3. 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 skin lesion count at the end of the visit compared to the baseline period of the study.

  4. Percentage change in total inflammatory 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 for all subjects at the end of the visit compared to the baseline period of the study.

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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