A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Incyte

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo; Drug: INCB054707

Study type: Interventional

Funder types: Industry

Identifiers

NCT03607487

INCB 54707-203

2018-000827-15 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 Hurley Stage III at screening.
• Total AN count of at least 3 at screening and baseline.
• Willingness to avoid pregnancy or fathering children.

Exclusion criteria

• Women who are currently pregnant or lactating.
• Presence of > 20 draining fistulas at screening and baseline.
• Participants with protocol-defined concurrent conditions or history of other diseases.
• Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
• Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
• A history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis.
• Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.
• Decreased blood cell counts at screening per protocol-defined criteria.
• Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.
• Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
• Use of protocol-prohibited medications.
• 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 before baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 3 patient groups

Cohort 1

Experimental group

Description:

INCB054707 at the Cohort 1 dose or placebo.

Treatment:

Drug: INCB054707

Drug: Placebo

Cohort 2

Experimental group

Description:

INCB054707 at the Cohort 2 dose or placebo.

Treatment:

Drug: INCB054707

Drug: Placebo

Cohort 3

Experimental group

Description:

INCB054707 at the Cohort 3 dose or placebo.

Treatment:

Drug: INCB054707

Drug: Placebo