A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Inclusion Criteria:

• Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
• Stable course of HS for at least 90 days before screening, as determined by the investigator.
• HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II or III at screening and baseline.
• Total AN count of at least 3 at screening and baseline.
• Male participants must agree to use contraception per protocol-defined criteria.

Exclusion Criteria:

• Women of childbearing potential or who are currently pregnant or lactating.
• Presence of > 20 draining fistulas at screening and baseline.

• Participants with concurrent conditions or history of other diseases as follows:

  • Any clinically significant medical condition other than HS, as determined by the investigator, that is not adequately controlled with appropriate treatment.
  • Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of HS.
  • Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, make the participant an unsuitable candidate for the study.
  • Current herpes zoster infection, a history of recurrent herpes zoster, a history of disseminated herpes simplex, or a history of herpes zoster.
  • History of malignancy, including lymphoma and leukemia within 5 years before baseline, other than a successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
  • Albinism.
• Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
• Positive test result for tuberculosis (TB) from the QuantiFERON-TB Gold test, or equivalent, at screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening) or a history of active TB.
• Positive serology test results for HIV, HBsAg, hepatitis B virus (HBV) core antibody, or HCV (HCV antibody with positive HCV-RNA) at screening.
• Decreased blood cell counts at screening as per protocol-defined parameters.
• Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 1.5 × upper limit of normal (ULN).
• Impaired renal function with serum creatinine > 1.5 mg/dL.
• Use of prohibited medications per protocol-defined criteria.
• Known or suspected allergy to INCB054707 or any component of the study drug.
• Known history of clinically significant drug or alcohol abuse in the last year prior to baseline.
• Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.