Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06248008
Other study ID # ASC40-304
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date April 24, 2024
Est. completion date March 9, 2026

Study information

Verified date February 2024
Source Ascletis Pharmaceuticals Co., Ltd.
Contact Xiang Leihong, Doctor
Phone 021-52888045
Email flora_xiang@vip.163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 240
Est. completion date March 9, 2026
Est. primary completion date October 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ASC40
ASC40 tablets orally once daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From the first dose to 40 weeks of treatment.
Primary 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. From the first dose to 40 weeks of treatment.
Primary 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. From the first dose to 40 weeks of treatment.
Secondary 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. up to 40 weeks.
Secondary 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. up to 40 weeks.
Secondary 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. up to 40 weeks.
Secondary 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. up to 40 weeks.
See also
  Status Clinical Trial Phase
Completed NCT05097157 - Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions N/A
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT04806594 - Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar. N/A
Recruiting NCT03465150 - Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital
Completed NCT02250859 - A Pharmacokinetic Study of Minocycline in Male and Female Volunteers Phase 1
Terminated NCT01193764 - Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris N/A
Completed NCT01206348 - Combination Treatment for Moderate to Severe Acne Phase 4
Completed NCT00725439 - An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne Phase 2
Completed NCT05640388 - Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects
Completed NCT04873089 - Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin
Recruiting NCT05941065 - Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin N/A
Recruiting NCT06120452 - A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation N/A
Completed NCT04300010 - Blue Light Therapy of C. Acnes Phase 4
Recruiting NCT06202274 - Clinical Study to Evaluate the Safety and Efficacy of Candela Technology N/A
Completed NCT04559022 - Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring N/A
Terminated NCT02431494 - Safety and Preliminary Efficacy of Combination Therapy for the Treatment of Acne Vulgaris N/A
Completed NCT05469880 - Efficacy and Tolerance of Formula 609613 37 in Acneic Patients N/A
Completed NCT02944461 - Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris Phase 4
Completed NCT01951417 - Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris Phase 4
Completed NCT01701024 - Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne Phase 3