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

• Status: Completed
• Trial end date: 2019-04-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).

• 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 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.