A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: INCB054707
Intervention description: INCB054707 administered once daily orally with water without regard to food for 8 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hidradenitis suppurativa (HS); Janus kinase (JAK); Janus kinase 1 (JAK1) inhibitor

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.