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

• Status: Completed
• Trial end date: 2019-08-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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.