a study of the safety of incb054707 in participants with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to assess the safety of incb054707 in men and women with moderate to severe hidradenitis suppurativa (hs).


Eligibility 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.

Keywords: hidradenitis suppurativa (hs) janus kinase (jak) janus kinase 1 (jak1) inhibitor