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

Last updated: March 11, 2025
Sponsor: Ascletis Pharmaceuticals Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Rash

Inflammatory Comedones

Acne

Treatment

ASC40

Clinical Study ID

NCT06248008
ASC40-304
  • Ages 18-40
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 effectivecontraception from the time they signed the informed consent until 3 months afterthe final administration of the investigationa drug;

  • Subjects are willing and able to complete the study, understand and comply with thestudy requirements, comply with the study requirements restrictions and relatededucation, use the investigational drug as prescribed by the physician, and followup according to the study schedule.

Exclusion

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 clinicallaboratory tests), mental disorders, or other factors deemed unsuitable for studyparticipation by the investigator.

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: ASC40
Phase: 3
Study Start date:
April 18, 2024
Estimated Completion Date:
March 09, 2026

Connect with a study center

  • Huashan Hospital Fudan University

    Shanghai, Shanghai 200000
    China

    Site Not Available

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