Tampa, Florida 33624

  • Hidradenitis Suppurativa

Purpose:

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


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.


NCT ID:

NCT03569371


Primary Contact:

Study Director
Kathleen Butler, MD
Incyte Corporation


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33624
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 30, 2021

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