AcnePhase 3NCT06248008
A Study to Evaluate Safety of ASC40 Tablets in Patients With Moderate to Severe Acne Vulgaris
A Phase 3 study testing ASC40 in people with Acne, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. 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?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2024to 12 Nov 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
- 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 effective contraception from the time they signed the informed consent until 3 months after the final administration of the investigationa drug;
- Subjects are willing and able to complete the study, understand and comply with the study requirements, comply with the study requirements restrictions and related education, use the investigational drug as prescribed by the physician, and follow up according to the study schedule.
Who cannot join
- 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 clinical laboratory tests), mental disorders, or other factors deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: An Open, Multicenter, Phase III Extension Clinical Trial to Evaluate the Long-term Safety of ASC40 (Denifanstat) Tablets in Patients With Moderate to Severe Acne Vulgaris
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.
- 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
ASC40 tablets orally once daily
| Study group | Role | What they receive |
|---|---|---|
| ASC40 50mg | Experimental | ASC40 50mg, up to 40 weeks of treatment. Receives: Drug: ASC40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with treatment emergent adverse events (TEAE)
The number and percentage of all subjects with treatment emergent adverse events (TEAE) from the first dose to 40 weeks of treatment.
Measured: From the first dose to 40 weeks of treatment.
Number and percentage of subjects with serious adverse event (SAE).
Number and percentage of subjects with serious adverse event (SAE) from the first dose to 40 weeks of treatment.
Measured: From the first dose to 40 weeks of treatment.
Number and percentage of subjects who discontinued due to adverse events.
Number and percentage of subjects who discontinued due to adverse events from the first dose to 40 weeks of treatment.
Measured: From the first dose to 40 weeks of treatment.
Secondary outcomes (4)
At the end of the visit, the number of people whose IGA rating had decreased by at least 2 points from the baseline period of the study.
At the end of the visit, the number of subjects whose IGA rating had decreased by at least 2 points from the baseline period of the study.
Measured: up to 40 weeks.
At the end of the visit, the number of subjects with an IGA score of 3 or higher at baseline dropped to an IGA score of 0 or 1.
At the end of the visit, the number of subjects with an IGA score of 3 or higher at baseline dropped to an IGA score of 0 or 1 among all subjects.
Measured: up to 40 weeks.
Percentage change in total skin lesion count at the end of the visit compared to the baseline period of the study.
Percentage change in total skin lesion count at the end of the visit compared to the baseline period of the study.
Measured: up to 40 weeks.
Percentage change in total inflammatory skin lesion count at the end of the visit compared to the baseline period of the study.
Percentage change in total inflammatory skin lesion count for all subjects at the end of the visit compared to the baseline period of the study.
Measured: up to 40 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start18 Apr 2024
- Primary completion12 Nov 2025
- Study completion12 Nov 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 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
- NCT06248008
- Sponsor's protocol ID
- ASC40-304
- Status last verified
- Nov 2025
- First submitted
- 31 Jan 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter, Phase III Extension Clinical Trial to Evaluate the Long-term Safety of ASC40 (Denifanstat) Tablets in Patients With Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06248008
- Acronym / sponsor ID
- ASC40-304
- Conditions
- Acne
- Keywords
- Acne, ASC40
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 8 Feb 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASC40 50mg | Experimental | Drug: ASC40ASC40 50mg, up to 40 weeks of treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 effective contraception from the time they signed the informed consent until 3 months after the final administration of the investigationa drug;
- Subjects are willing and able to complete the study, understand and comply with the study requirements, comply with the study requirements restrictions and related education, use the investigational drug as prescribed by the physician, and follow up according to the study schedule.
Key exclusion criteria (4 listed)
- 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 clinical laboratory tests), mental disorders, or other factors deemed unsuitable for study participation by the investigator.
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 |
|---|---|---|
| ASC40ASC40 tablets orally once daily | Drug | ASC40 50mg |
Primary outcome
Number and percentage of subjects with treatment emergent adverse events (TEAE)
Time frame: From the first dose to 40 weeks of treatment.
The number and percentage of all subjects with treatment emergent adverse events (TEAE) from the first dose to 40 weeks of treatment.
Number and percentage of subjects with serious adverse event (SAE).
Time frame: From the first dose to 40 weeks of treatment.
Number and percentage of subjects with serious adverse event (SAE) from the first dose to 40 weeks of treatment.
Number and percentage of subjects who discontinued due to adverse events.
Time frame: From the first dose to 40 weeks of treatment.
Number and percentage of subjects who discontinued due to adverse events from the first dose to 40 weeks of treatment.
4 secondary outcomes
At the end of the visit, the number of people whose IGA rating had decreased by at least 2 points from the baseline period of the study.
Time frame: up to 40 weeks.
At the end of the visit, the number of subjects with an IGA score of 3 or higher at baseline dropped to an IGA score of 0 or 1.
Time frame: up to 40 weeks.
Percentage change in total skin lesion count at the end of the visit compared to the baseline period of the study.
Time frame: up to 40 weeks.
Percentage change in total inflammatory skin lesion count at the end of the visit compared to the baseline period of the study.
Time frame: up to 40 weeks.
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 1 Dec 2025.
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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.
1 site 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 1 site 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 4 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 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Number and percentage of subjects with treatment emergent adverse events (TEAE) (time frame: From the first dose to 40 weeks 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 1 Dec 2025.