drugset / Trial / NCT07863193
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of denifanstat compared with matching placebo in participants with moderate to severe acne vulgaris who are ≥12 years of age. After the 12-week treatment phase, a subset of approximately 530 participants will have the option to consent to an open-label extension phase for an additional 40 weeks of treatment.
Timeline
- Start
- 2026-10
- Primary completion
- 2027-08
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denifanstat | Small molecule | — | Oral |