Last updated on September 2020

A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hidradenitis Suppurativa
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

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 Hurley Stage III at screening.
  • Total AN count of at least 3 at screening and baseline.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • Women who are currently pregnant or lactating.
  • Presence of > 20 draining fistulas at screening and baseline.
  • Participants with protocol-defined concurrent conditions or history of other diseases.
  • Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as 450 msec.
  • Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
  • A history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis.
  • Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.
  • Decreased blood cell counts at screening per protocol-defined criteria.
  • Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase levels 1.5 upper limit of normal at screening.
  • Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
  • Use of protocol-prohibited medications.
  • 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 before baseline.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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