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Denifanstat in Moderate to Severe Acne Vulgaris
NCT07863193Phase 3
Key facts
- Status
- Recruiting
- Start
- Oct 2026
- Primary completion
- Aug 2027
- Countries
- 1
- Sponsor
- Sagimet Biosciences
- Drugs
- denifanstat
- Conditions
- acne vulgaris
01
Overview
Phase 3, randomised, double-blind trial in acne vulgaris comparing Denifanstat with Placebo (2 arms). Primary endpoints: Proportion of participants achieving Investigator's Global Assessment (EGSS) success at 12 weeks, Absolute change from baseline in inflammatory lesion count at 12 weeks and 1 more. Started Oct 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Denifanstat
Oral, once daily
Placebo
Oral, once daily
03
Who it enrols
Participants aged 12 and older with moderate to severe acne vulgaris (EGSS 3-4, 30-75 inflammatory lesions, 30-100 noninflammatory lesions). Excludes those with cystic acne, >2 facial cysts/nodules, or using certain prohibited medications.
04
Endpoints
Primary
Proportion of participants achieving Investigator's Global Assessment (EGSS) success
Absolute change from baseline in inflammatory lesion count
Absolute change from baseline in non-inflammatory lesion count
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