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

Incyte Corporation10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

INCB054707DRUG

INCB054707 administered once daily orally with water without regard to food for 8 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (4)

Investigative Site

Los Angeles, California, United States

Investigative Site

Tampa, Florida, United States

Investigative Site

New York, New York, United States

Investigative Site

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Time frame: Up to approximately 12 weeks.

Secondary Outcomes

Apparent Oral Clearance of INCB054707(CL/F)

To evaluate the systemic exposure to INCB054707.

Time frame: Postdose Day1, week 2 and 6

Apparent Oral Volume of Distribution of INCB054707(Vc/F)

To evaluate the systemic exposure to INCB054707.

Time frame: Postdose Day1, week 2 and 6.

Absorption Constant of INCB054707 (Ka)

Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.

Time frame: Postdose Day1, week 2 and 6.

Apparent Inter-compartmental Clearance(Q/F)

Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.

Time frame: Postdose Day1, week 2 and 6.

Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit

An HiSCR is defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline at each visit.

Time frame: Weeks 1,2,4,6,8 and FollowUp

Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit

Data from ClinicalTrials.gov

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