Back to resultsA Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INCB054707
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis suppurativa, Janus kinase (JAK) inhibitor, skin disease
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.
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site 009
- Investigative Site 008
- Investigative Site 007
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
INCB054707 at the Cohort 1 dose or placebo.
INCB054707 at the Cohort 2 dose or placebo.
INCB054707 at the Cohort 3 dose or placebo.
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Apparent Oral Clearance of INCB054707
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Apparent Oral Volume of Distribution of INCB054707
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
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.
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
AN defined as abscess and inflammatory nodule count.
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").
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03607487
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
August 13, 2019 (Actual)
Study Completion Date
August 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis suppurativa, Janus kinase (JAK) inhibitor, skin disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
INCB054707 at the Cohort 1 dose or placebo.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
INCB054707 at the Cohort 2 dose or placebo.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
INCB054707 at the Cohort 3 dose or placebo.
Intervention Type
Drug
Intervention Name(s)
INCB054707
Other Intervention Name(s)
Povorcitinib
Intervention Description
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet administered orally once daily.
Primary Outcome Measure Information:
Title
Number of Treatment-emergent Adverse Events (TEAEs)
Description
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".
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Apparent Oral Clearance of INCB054707
Description
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Time Frame
Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Title
Apparent Oral Volume of Distribution of INCB054707
Description
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Time Frame
Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Title
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Description
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.
Time Frame
Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Title
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Description
AN defined as abscess and inflammatory nodule count.
Time Frame
Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Title
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Description
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").
Time Frame
Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Title
Mean Change From Baseline in the Modified Sartorius Scale Score
Description
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.
Time Frame
From baseline up to week 8
Title
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Description
Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Time Frame
Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)
Title
Proportion of Participants at Each Category of Hurley Stage
Description
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.
Time Frame
Baseline and Week 8
Title
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Description
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.
Time Frame
Up to 12 weeks
Title
Actual Measurements in HS-PGIC at Each Visit
Description
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.
Time Frame
Up to 12 weeks
Title
Proportion of Participants With Change From Baseline Hurley Stage
Description
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.
Time Frame
Baseline and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Butler, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Investigative Site
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Investigative Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Investigative Site 009
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Investigative Site 008
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Investigative Site 007
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Investigative Site
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 5L4
Country
Canada
Facility Name
Investigative Site
City
St-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Investigative Site
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Investigative Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Investigative Site
City
Bochum
State/Province
Noth Rhine-Westphalia
ZIP/Postal Code
44791
Country
Germany
Facility Name
Investigative Site
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34978076
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.
Results Reference
derived
Learn more about this trial
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
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