Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)

Inclusion Criteria

• Must be willing and able to participate in the trial and provide written informed consent or assent
• Aged ≥12 years on the date that written informed consent/ assent is provided
• Moderate to severe acne vulgaris based on the following criteria at screening:

• The EGSS at screening of 3 or 4.

AND

• Number of facial skin lesions:

• 30 to 75 inflammatory lesions
• 30 to 100 noninflammatory lesions
• All participants with their partners, if any, must agree to the use of an acceptable method of highly effective contraception. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding, must not plan to become pregnant during the study, and must use 2 forms of birth control, one being a barrier method, or be sexually abstinent.

Exclusion Criteria

• Presence of >2 facial cysts/ nodules
• Cystic acne, acne fulminans or acne conglobata
• Other significant skin diseases that may affect the efficacy evaluation or require co-treatment
• History of clinically significant dry eye, such as Ocular Surface Disease Index (OSDI) ≥33, or corneal staining ≥ grade III on Oxford Grading Scale, chronic dry eye, or other corneal abnormality
• Use of concomitant strong cytochrome P450 (CYP) 3A4 inducers and strong or moderate inhibitors within 2 weeks prior to Day 1 the trial except Paxlovid®
• Use of a glucagon-like-peptide 1 (GLP-1) agonist for \<12 weeks prior to first dose of trial medication
• Use of any of the following:

• Introduction of any drug known to prolong QT interval corrected for heart rate (QTC)
• Sensitive substrates of P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP)
• Herbs and supplements such as St John's Wort or grapefruit juice.
• Use of concomitant acne treatments unless appropriate washout period is documented