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

A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: INCB054707; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Investigative Site
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Investigative Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Investigative Site
    • London, Ontario, Canada, N6H 5L5
      • Investigative Site
    • Markham, Ontario, Canada, L3P 1X2
      • Investigative Site 009
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • Investigative Site 008
    • Windsor, Ontario, Canada, N8W 5L7
      • Investigative Site 007
  • Quebec
    • Drummondville, Quebec, Canada, J2B 5L4
      • Investigative Site
    • St-Jerome, Quebec, Canada, J7Z 7E2
      • Investigative Site
• Denmark
  • Aarhus, Denmark, 8200
    • Investigative Site
  • Roskilde, Denmark, 4000
    • Investigative Site
• Germany
  • Noth Rhine-Westphalia
    • Bochum, Noth Rhine-Westphalia, Germany, 44791
      • Investigative Site
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; INCB054707 at the Cohort 1 dose or placebo.	Drug: INCB054707; INCB054707 tablet administered orally once daily at the protocol-defined dose.; Other Names: Povorcitinib; Drug: Placebo; Placebo tablet administered orally once daily.
Experimental: Cohort 2; INCB054707 at the Cohort 2 dose or placebo.	Drug: INCB054707; INCB054707 tablet administered orally once daily at the protocol-defined dose.; Other Names: Povorcitinib; Drug: Placebo; Placebo tablet administered orally once daily.
Experimental: Cohort 3; INCB054707 at the Cohort 3 dose or placebo.	Drug: INCB054707; INCB054707 tablet administered orally once daily at the protocol-defined dose.; Other Names: Povorcitinib; Drug: Placebo; Placebo tablet administered orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-emergent Adverse Events (TEAEs)	TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe".	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apparent Oral Clearance of INCB054707	To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.	Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Apparent Oral Volume of Distribution of INCB054707	To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.	Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit	HiSCR defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.	Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit	AN defined as abscess and inflammatory nodule count.	Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit	An 11-point scale used to assess the worst skin pain and the average skin pain due to HS. Skin pain ranges from 0 ("no skin pain") to 10 ("skin pain as bad as you can imagine").	Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Mean Change From Baseline in the Modified Sartorius Scale Score	The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS.	From baseline up to week 8
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.	Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.	Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)
Proportion of Participants at Each Category of Hurley Stage	The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.	Baseline and Week 8
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period	The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.	Up to 12 weeks
Actual Measurements in HS-PGIC at Each Visit	The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.	Up to 12 weeks
Proportion of Participants With Change From Baseline Hurley Stage	The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Incyte Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): August 13, 2019
• Study Completion (Actual): August 13, 2019

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: skin disease; Hidradenitis suppurativa; Janus kinase (JAK) inhibitor
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: INCB 54707-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes