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

NCT ID: NCT03569371

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2019-04-22

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INCB054707

Group Type: EXPERIMENTAL

INCB054707

Intervention Type: DRUG

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

Interventions

INCB054707

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

Intervention Type: DRUG

Other Intervention Names

Povorcitinib

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Butler, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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

Countries

United States

References

Alavi A, Hamzavi I, Brown K, Santos LL, Zhu Z, Liu H, Howell MD, Kirby JS. Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase II studies. Br J Dermatol. 2022 May;186(5):803-813. doi: 10.1111/bjd.20969. Epub 2022 Mar 6.

Reference Type: DERIVED

PMID: 34978076 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INCB 54707-202

Identifier Type: -

Identifier Source: org_study_id