Acne Vulgaris study: Denifanstat
Official title Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
ClinicalTrials.gov ID: NCT07863193
What this study is testing
What is Denifanstat?
Denifanstat is an investigational oral medicine being studied as a potential treatment for moderate to severe acne vulgaris.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if denifanstat is safe and works better than a placebo for moderate to severe acne.
- Who it's for
- People aged 12 years or older who have moderate to severe acne vulgaris.
- What's involved
- Participants will take either denifanstat or a matching placebo for 12 weeks and can choose to continue with an open‑label extension for up to 40 more weeks.
- Time commitment
- The main study lasts 12 weeks with clinic visits, and an optional additional 40‑week extension if the participant consents.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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
- The EGSS at screening of 3 or 4. AND
- 30 to 75 inflammatory lesions
- 30 to 100 noninflammatory lesions
You likely can't join if
- Presence of \>2 facial cysts/ nodules
- Cystic acne, acne fulminans or acne conglobata
- Other significant skin diseases that may affect the how well it works 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...
- Use of concomitant strong cytochrome P450 (CYP) 3A4 inducers and strong or moderate inhibitors within 2 weeks prior to Day 1 the trial except...
- Use of a glucagon-like-peptide 1 (GLP-1) agonist for \<12 weeks prior to first dose of trial medication
See the full eligibility 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
- The EGSS at screening of 3 or 4. AND
- 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.
- Presence of \>2 facial cysts/ nodules
- Cystic acne, acne fulminans or acne conglobata
- Other significant skin diseases that may affect the how well it works 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Bryant, Arkansas, United States
- Beverly Hills, California, United States
- Fremont, California, United States
- San Diego, California, United States
- Santa Ana, California, United States
- Doral, Florida, United States
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
- Miramar, Florida, United States
- Sweetwater, Florida, United States
- Lincolnshire, Illinois, United States
- Indianapolis, Indiana, United States
- New Albany, Indiana, United States
- Clinton Township, Michigan, United States
- Omaha, Nebraska, United States
- Portsmouth, New Hampshire, United States
- Robbinsville, New Jersey, United States
- Wilmington, North Carolina, United States
- Columbus, Ohio, United States
- East Greenwich, Rhode Island, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bryant, Arkansas, United States; Beverly Hills, California, United States; Fremont, California, United States; San Diego, California, United States; Santa Ana, California, United States; Doral, Florida, United States and 20 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.