A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris
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..
Timeline
- Start
- 2024-01-23
- Primary completion
- 2025-05-19
- Completion
- 2025-05-19
Outcome
Met primary endpoint
release “III期研究（ NCT06192264 ）。在该III期研究中，地尼法司他（ASC40）达到所有主要、关键次要及次要疗效终点” ascletis.com ↗
release “denifanstat (ASC40) met all primary, key secondary, and secondary endpoints in a 480-patient randomized, double-blind, placebo-controlled Phase 3 clinical trial (NCT06192264, ASC40-303)” sagimet.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denifanstat | Small molecule | — | Oral |