A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

INCB 54707-202

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

2018-07-17

2019-04-22

2019-04-22

Completed

Early phase I

10

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2022-09-26