Clinical trial NCT03607487: A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Official title: A Phase 2, Dose-Escalation, Placebo-Controlled 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
Janus kinase (JAK) inhibitor
skin disease
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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 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.

Primary outcomes:
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Apparent Oral Clearance of INCB054707
timeFrame: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
measure: Apparent Oral Volume of Distribution of INCB054707
timeFrame: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
measure: Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
timeFrame: Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
measure: Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
timeFrame: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
measure: Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
timeFrame: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
measure: Mean Change From Baseline in the Modified Sartorius Scale Score
timeFrame: From baseline up to week 8
measure: Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
timeFrame: Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)
measure: Proportion of Participants at Each Category of Hurley Stage
timeFrame: Baseline and Week 8
measure: Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
timeFrame: Up to 12 weeks
measure: Actual Measurements in HS-PGIC at Each Visit
timeFrame: Up to 12 weeks
measure: Proportion of Participants With Change From Baseline Hurley Stage
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Investigative Site
state: Manitoba
city: Fredericton
country: Canada
facility: Investigative Site
state: New Brunswick
city: Barrie
country: Canada
facility: Investigative Site
state: Ontario
city: London
country: Canada
facility: Investigative Site
state: Ontario
city: Markham
country: Canada
facility: Investigative Site 009
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigative Site 008
state: Ontario
city: Windsor
country: Canada
facility: Investigative Site 007
state: Ontario
city: Drummondville
country: Canada
facility: Investigative Site
state: Quebec
city: St-Jerome
country: Canada
facility: Investigative Site
state: Quebec
city: Aarhus
country: Denmark
facility: Investigative Site
city: Roskilde
country: Denmark
facility: Investigative Site
city: Bochum
country: Germany
facility: Investigative Site
state: Noth Rhine-Westphalia
city: Lübeck
country: Germany
facility: Investigative Site
state: Schleswig-Holstein
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.