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

NCT03569371 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INCB 54707-202
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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

Keywords

Hidradenitis suppurativa (HS); Janus kinase (JAK); Janus kinase 1 (JAK1) inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 12 weeks.

Secondary Outcomes (15)

• Apparent Oral Clearance of INCB054707(CL/F)

  Postdose Day1, week 2 and 6

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

  Postdose Day1, week 2 and 6.

• Absorption Constant of INCB054707 (Ka)

  Postdose Day1, week 2 and 6.

• Apparent Inter-compartmental Clearance(Q/F)

  Postdose Day1, week 2 and 6.

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

  Weeks 1,2,4,6,8 and FollowUp

Study Arms (1)

INCB054707

EXPERIMENTAL

Drug: INCB054707

Interventions

INCB054707 DRUG

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

Also known as: Povorcitinib

INCB054707

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (4)

Investigative Site

Los Angeles, California, 90045, United States

Location

Investigative Site

Tampa, Florida, 33624, United States

Location

Investigative Site

New York, New York, 10065, United States

Location

Investigative Site

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• 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.

  PMID: 34978076 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Incyte Corporation Call Center, Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Kathleen Butler, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 26, 2018
• Study Start: July 17, 2018
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: September 26, 2022
• Results First Posted: May 20, 2020

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)