Denifanstat vs placebo for moderate to severe acne in teens and adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 trial, participants with moderate to severe acne vulgaris will receive denifanstat or placebo for 12 weeks to assess safety and effectiveness. After the initial treatment period, about 530 participants may join an open-label extension for an additional 40 weeks of treatment. Eligible participants include those aged 12+ with defined inflammatory and noninflammatory facial lesions, and they must use effective contraception if applicable. Key exclusion criteria include certain severe acne forms and other skin diseases that could affect evaluation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

   1. The EGSS at screening of 3 or 4.

      AND
   2. Number of facial skin lesions:

      * 30 to 75 inflammatory lesions
      * 30 to 100 noninflammatory lesions
4. 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:

1. Presence of \>2 facial cysts/ nodules
2. Cystic acne, acne fulminans or acne conglobata
3. Other significant skin diseases that may affect the efficacy evaluation or require co-treatment
4. 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
5. 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®
6. Use of a glucagon-like-peptide 1 (GLP-1) agonist for \<12 weeks prior to first dose of trial medication
7. Use of any of the following:

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

Where it's running

• Sagimet Investigative Site
  Bryant, Arkansas, United States Recruiting
• Sagimet Investigative Site
  Beverly Hills, California, United States Recruiting
• Sagimet Investigative Site
  Fremont, California, United States Recruiting
• Sagimet Investigative Site
  San Diego, California, United States Recruiting
• Sagimet Investigative Site
  Santa Ana, California, United States Recruiting
• Sagimet Investigative Site
  Doral, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicalhotline@sagimet.com
• Phone: (650) 561-8675

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.