Clinical trial NCT03569371: A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Official title: A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis suppurativa (HS)
Janus kinase (JAK)
Janus kinase 1 (JAK1) inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 12 weeks.
Secondary outcomes:
measure: Apparent Oral Clearance of INCB054707(CL/F)
timeFrame: Postdose Day1, week 2 and 6
measure: Apparent Oral Volume of Distribution of INCB054707(Vc/F)
timeFrame: Postdose Day1, week 2 and 6.
measure: Absorption Constant of INCB054707 (Ka)
timeFrame: Postdose Day1, week 2 and 6.
measure: Apparent Inter-compartmental Clearance(Q/F)
timeFrame: Postdose Day1, week 2 and 6.
measure: Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
timeFrame: Weeks 1,2,4,6,8 and FollowUp
measure: Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
timeFrame: Weeks 1,2,4,6,8 and FollowUp
measure: Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
timeFrame: Weeks 1,2,4,6,8 and FollowUp
measure: Mean Change From Baseline in the Modified Sartorius Scale Score
timeFrame: Week 8.
measure: Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
timeFrame: Up to approximately 12 weeks.
measure: Proportion of Participants at Each Category of Hurley Stage
timeFrame: Baseline and Week 8.
measure: Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
timeFrame: Week 8.
measure: Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
timeFrame: Up to approximately 12 weeks.
measure: Proportion of Participants Requiring Rescue Lesional Treatment
timeFrame: Up to approximately 12 weeks.
measure: Number of Interventions With Rescue Lesional Treatment
timeFrame: Up to approximately 12 weeks.
measure: Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
timeFrame: Up to approximately 12 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: Tampa
country: United States
facility: Investigative Site
state: Florida
city: New York
country: United States
facility: Investigative Site
state: New York
city: Hershey
country: United States
facility: Investigative Site
state: Pennsylvania
Study officials:
affiliation: Incyte Corporation
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
References:
citation: 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.