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NCT Number: NCT06192264

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

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..

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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

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

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

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 use effective contraception from the time of signing the informed consent until 3 months after the last dose of the investigational drug; women of childbearing potential include premenopausal women and women within 2 years of menopause. Women of childbearing potential must have a negative pregnancy test result within ≤ 7 days prior to the first dose of the investigational drug.
  • Subjects are willing and able to complete the study, are able to understand and comply with the study requirements, adhere to the study required restrictions and related tutorials, use the investigational drug as prescribed, and are followed up according to the study plan.

Exclusion criteria

  • Known hypersensitivity to the ingredients of ASC40 (Denifanstat) tablets or to any of the excipients.
  • Presence of cystic acne at screening.
  • Patients with secondary acne such as occupational acne (e.g., chloracne) and corticosteroid-induced secondary acne (e.g., chloracne or drug-induced acne)
  • Patients with other significant coexisting skin conditions that may affect the evaluation 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 accurate assessment of acne vulgaris grades or lesion counts

Treatment and study plan

ASC40

Drug

ASC 40 tablets orally once daily

Primary outcomes

  1. Percentage of treatment success based on investigator's global assessment (IGA) in each group of subjects

    Time frame: At Week 12 of treatment.

    Percentage of treatment success subjects in each group based on investigator's global assessment (IGA) at Week 12 (treatment success defined as an IGA grade of 0 or 1, and a ≥2-grade decrease in IGA grade from baseline)

  2. Percentage change in total skin lesion counts compared to baseline ineach group of subjects

    Time frame: At Week 12 of treatment.

    Percentage change in total skin lesion counts compared to baseline for subjects in each group at Week 12

  3. Percentage change in the count of inflammatory skin lesions compared to baseline in each group of subjects

    Time frame: At Week 12 of treatment.

    Percentage change in inflammatory skin lesion counts compared to baseline for subjects in each group at Week 12

Secondary outcomes

  1. Percentage change in non-inflammatory lesion counts compared to baseline for each group of subjects

    Time frame: At Week 12 of treatment.

    Percentage change in non-inflammatory lesion counts compared to baseline for subjects in each group at Week 12

  2. Absolute change in total skin lesion counts compared to baseline for each group of subjects

    Time frame: At Week 12 of treatment.

    Absolute change in total skin lesion counts compared to baseline for each group of subjects at Week 12

  3. Absolute change in inflammatory skin lesion counts compared to baseline in each group of subjects

    Time frame: At Week 12 of treatment.

    Absolute change in inflammatory skin lesion counts compared to baseline in each group of subjects at Week 12

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Safety and Efficacy of ASC40 (Denifanstat) Tablets in Subjects With Moderate to Severe Acne Vulgaris

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Jun 19, 2025

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

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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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