A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris

Last updated: June 17, 2025
Sponsor: Ascletis Pharmaceuticals Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Rash

Scalp Disorders

Acne

Treatment

ASC40

Clinical Study ID

NCT06192264
ASC40-303
  • Ages 18-40
  • All Genders

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of ASC40 (Denifanstat) tablets compared to placebo in the treatment of patients with moderate to severe acne vulgaris. The proposed plan for this trial is to enroll subjects who are 18-40 years of age (including borderline values), with a diagnosis of moderate to severe acne vulgaris, and an Investigator's Global Assessment (IGA) graded as moderate (grade 3) or severe (grade 4). 480 subjects were planned to be enrolled in the trial and placebo groups, with all subjects randomly assigned in a 1:1 ratio to receive either ASC40 (denifanstat) tablets dose 1 or placebo, administered orally once daily (taken after dinner) for 12 weeks.

There will be a total of 6 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:

  • Age 18-40 years (inclusive of threshold), gender is not limited.

  • Subjects have an Investigator's Global Assessment (IGA) score of 3 or 4 (i.e.,moderate or severe).

  • Men of childbearing potential and women of childbearing potential willing to useeffective contraception from the time of signing the informed consent until 3 monthsafter the last dose of the investigational drug; women of childbearing potentialinclude premenopausal women and women within 2 years of menopause. Women ofchildbearing potential must have a negative pregnancy test result within ≤ 7 daysprior to the first dose of the investigational drug.

  • Subjects are willing and able to complete the study, are able to understand andcomply with the study requirements, adhere to the study required restrictions andrelated tutorials, use the investigational drug as prescribed, and are followed upaccording to the study plan.

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to the ingredients of ASC40 (Denifanstat) tablets or to anyof the excipients.

  • Presence of cystic acne at screening.

  • Patients with secondary acne such as occupational acne (e.g., chloracne) andcorticosteroid-induced secondary acne (e.g., chloracne or drug-induced acne)

  • Patients with other significant coexisting skin conditions that may affect theevaluation of facial acne efficacy or require co-treatment, such as solardermatitis,psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema, etc..

  • Thicker facial hair, which has been assessed by researchers to impede accurateassessment of acne vulgaris grades or lesion counts

Study Design

Total Participants: 480
Treatment Group(s): 1
Primary Treatment: ASC40
Phase: 3
Study Start date:
January 23, 2024
Estimated Completion Date:
May 19, 2025

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui
    China

    Site Not Available

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui
    China

    Site Not Available

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui
    China

    Site Not Available

  • Beijing Tsinghua Changgeng Hospital

    Beijing, Beijing
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Shenzhen Hospital, The University of Hong Kong

    Shenzhen, Guangdong
    China

    Site Not Available

  • The Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong
    China

    Site Not Available

  • Guilin Medical College Affiliated Hospital

    Guilin, Guangxi
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangzhou
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangzhou
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • Nanyang First People's Hospital

    Nanyang, Henan
    China

    Site Not Available

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

  • Wuhan Central Hospital

    Wuhan, Hubei
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Changzhou First People's Hospital

    Changzhou, Jiangsu
    China

    Site Not Available

  • Lianyungang First People's Hospital

    Lianyungang, Jiangsu
    China

    Site Not Available

  • The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Medical College

    Xi'an, Shanxi
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University School of Medicine

    Xi'an, Shanxi
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • Suining Central Hospital

    Suining, Sichuan
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjing, Tianjing
    China

    Site Not Available

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Ningbo Second Hospital

    Ningbo, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    Yiwu, Zhejiang
    China

    Site Not Available

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