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

NCT06192264 | Completed Phase 3

• 1 other identifier: ASC40-303
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 41

Brief 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..

Conditions

Acne

Keywords

Acne; ASC40

Outcome Measures

Primary Outcomes (3)

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

  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)

  At Week 12 of treatment.

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

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

  At Week 12 of treatment.

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

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

  At Week 12 of treatment.

Secondary Outcomes (3)

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

  At Week 12 of treatment.

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

  At Week 12 of treatment.

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

  At Week 12 of treatment.

Study Arms (2)

ASC40 dose 1

EXPERIMENTAL

ASC40 dose 1 84 days of treatment

Drug: ASC40

ASC40 Placebo

PLACEBO COMPARATOR

ASC40 Placebo 84 days of treatment

Drug: ASC40

Interventions

ASC40 DRUG

ASC 40 tablets orally once daily

ASC40 Placebo; ASC40 dose 1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (41)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Beijing Tsinghua Changgeng Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The Fifth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Shenzhen Hospital, The University of Hong Kong

Shenzhen, Guangdong, China

Location

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Location

Guilin Medical College Affiliated Hospital

Guilin, Guangxi, China

Location

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

Guangzhou, Guangzhou, China

Location

Shenzhen People's Hospital

Shenzhen, Guangzhou, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Nanyang First People's Hospital

Nanyang, Henan, China

Location

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

Wuhan, Hubei, China

Location

Wuhan Central Hospital

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Changzhou First People's Hospital

Changzhou, Jiangsu, China

Location

Lianyungang First People's Hospital

Lianyungang, Jiangsu, China

Location

The First Affiliated Hospital of Gannan Medical College

Ganzhou, Jiangxi, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital of Xi'an Medical College

Xi’an, Shanxi, China

Location

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

Xi’an, Shanxi, China

Location

Chengdu Second People's Hospital

Chengdu, Sichuan, China

Location

Suining Central Hospital

Suining, Sichuan, China

Location

Tianjin Medical University General Hospital

Tianjing, Tianjing, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Location

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

Hangzhou, Zhejiang, China

Location

Ningbo Second Hospital

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 5, 2024
• Study Start: January 23, 2024
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (41)