AcnePhase 3NCT06192264
A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris
A Phase 3 study testing ASC40 in people with Acne, run by Ascletis Pharmaceuticals Co., Ltd. at 41 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne
- What is being tested?
- ASC40
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 41 sitesChina
- Study dates
- 23 Jan 2024to 19 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
China41 sites
Beijing Tsinghua Changgeng Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Changzhou First People's Hospital
Changzhou, Jiangsu
Chengdu Second People's Hospital
Chengdu, Sichuan
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
The First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
The Fifth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangzhou
Guilin Medical College Affiliated Hospital
Guilin, Guangxi
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Lianyungang First People's Hospital
Lianyungang, Jiangsu
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Nanyang First People's Hospital
Nanyang, Henan
Ningbo Second Hospital
Ningbo, Zhejiang
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200000
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality
Shenzhen Hospital, The University of Hong Kong
Shenzhen, Guangdong
Shenzhen People's Hospital
Shenzhen, Guangzhou
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Suining Central Hospital
Suining, Sichuan
Tianjin Medical University General Hospital
Tianjing, Tianjing
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Wuhan Central Hospital
Wuhan, Hubei
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
The First Affiliated Hospital of Xi'an Medical College
Xi’an, Shanxi
The Second Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Xi’an, Shanxi
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
About this study
Official 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
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
- Being tested
- ASC40
- Keywords
- Acne, ASC40
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC40Drug
ASC 40 tablets orally once daily
| Study group | Role | What they receive |
|---|---|---|
| ASC40 dose 1 | Experimental | ASC40 dose 1 84 days of treatment Receives: Drug: ASC40 |
| ASC40 Placebo | Placebo comparator | ASC40 Placebo 84 days of treatment Receives: Drug: ASC40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: At Week 12 of treatment.
Secondary outcomes (3)
Percentage change in non-inflammatory lesion counts compared to baseline for each group of subjects
Percentage change in non-inflammatory lesion counts compared to baseline for subjects in each group at Week 12
Measured: At Week 12 of treatment.
Absolute change in total skin lesion counts compared to baseline for each group of subjects
Absolute change in total skin lesion counts compared to baseline for each group of subjects at Week 12
Measured: At Week 12 of treatment.
Absolute change in inflammatory skin lesion counts compared to baseline in each group of subjects
Absolute change in inflammatory skin lesion counts compared to baseline in each group of subjects at Week 12
Measured: At Week 12 of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start23 Jan 2024
- Primary completion19 May 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192264
- Sponsor's protocol ID
- ASC40-303
- Status last verified
- May 2025
- First submitted
- 14 Dec 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06192264
- Acronym / sponsor ID
- ASC40-303
- Conditions
- Acne
- Keywords
- Acne, ASC40
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASC40 dose 1 | Experimental | Drug: ASC40ASC40 dose 1 84 days of treatment |
| ASC40 Placebo | Placebo comparator | Drug: ASC40ASC40 Placebo 84 days of treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC40ASC 40 tablets orally once daily | Drug | ASC40 Placebo, ASC40 dose 1 |
Primary outcome
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)
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
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
3 secondary outcomes
Percentage change in non-inflammatory 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
Time frame: At Week 12 of treatment.
Absolute change in inflammatory skin lesion counts compared to baseline in each group of subjects
Time frame: At Week 12 of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASC40 in people with Acne, run by Ascletis Pharmaceuticals Co., Ltd. at 41 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of treatment success based on investigator's global assessment (IGA) in each group of subjects (time frame: At Week 12 of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.