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

Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - 75
Start Date:June 11, 2018
End Date:April 2019
Contact:Incyte Corporation Call Center (US)

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

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

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

- 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.
We found this trial at
Tampa, Florida 33624
Phone: 813-264-2155
Tampa, FL
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Hershey, Pennsylvania 17033
Phone: 717-531-0003
Hershey, PA
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Los Angeles, California 90045
Phone: 310-337-7171
Los Angeles, CA
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1230 York Ave
New York, New York 10065
(212) 327-8000
Phone: 800-782-2737
Rockefeller University The Rockefeller University is a world-renowned center for research and graduate education in...
New York, NY
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