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

ConditionAcne Vulgaris
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorSagimet Biosciences Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

30 to 75 inflammatory lesions

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Denifanstat

    Drug

    Oral, once daily

  • Placebo

    Other intervention

    Oral, once daily

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: DenifanstatExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving EGSS success, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from their baseline score

Time frame
Week 12
2

Absolute change from baseline in inflammatory lesion count (ILC)

Time frame
Week 12
3

Absolute change from baseline in non-inflammatory lesion count (ILC)

Time frame
Week 12

Secondary outcomes

Other outcomes

1

Safety and tolerability (Open-Label Extension)

Incidence of treatment-emergent adverse events and serious adverse events; change from baseline in safety parameters

Time frame
Week 52

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sagimet Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov
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