Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis suppurativa, Janus kinase (JAK) inhibitor, skin disease
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.
Interventions
DRUGINCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
DRUGPlacebo
Placebo tablet administered orally once daily.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) | Up to 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Apparent Oral Clearance of INCB054707 | Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8 | To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707. |
| Apparent Oral Volume of Distribution of INCB054707 | Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8 | 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 | Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) | 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 | Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) | 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 | Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) | 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 Number of Draining Fistulas Count at Each Visit. | Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months) | Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. |
| Proportion of Participants at Each Category of Hurley Stage | Baseline and Week 8 | 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 | Up to 12 weeks | 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 | Up to 12 weeks | 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 | Baseline and Week 8 | 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. |
| Mean Change From Baseline in the Modified Sartorius Scale Score | From baseline up to week 8 | 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. |
Countries
Canada, Denmark, Germany
Participant flow
Recruitment details
The study was conducted at 9 different sites in Canada, 2 different sites in Germany and 1 site in Denmark
Pre-assignment details
A total of 43 participants were screened for enrollment in the study, 8 did not meet the eligibility criteria. A total of 35 participants were randomized to one of the treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo was administered QD over an 8 week treatment period. | 9 |
| INCB054707 at 30 mg INCB054707 was administered at 30 mg QD over an 8 week treatment period. | 9 |
| INCB054707 at 60 mg INCB054707 was administered at 60 mg QD over an 8 week treatment period. | 9 |
| INCB054707 at 90 mg INCB054707 was administered at 90 mg QD over an 8 week treatment period. | 8 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | INCB054707 at 30 mg | Placebo | INCB054707 at 60 mg | INCB054707 at 90 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 11.53 | 40.3 years STANDARD_DEVIATION 16.7 | 42.2 years STANDARD_DEVIATION 11.96 | 42.8 years STANDARD_DEVIATION 14.62 | 41.5 years STANDARD_DEVIATION 13.25 |
| Race/Ethnicity, Customized American-Indian/Alaska Native | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African-American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 7 Participants | 9 Participants | 9 Participants | 8 Participants | 33 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 7 Participants | 8 Participants | 9 Participants | 7 Participants | 31 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 8 Participants | 5 Participants | 28 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 35 |
| other Total, other adverse events | 4 / 9 | 8 / 9 | 6 / 9 | 7 / 8 | 25 / 35 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 35 |
Outcome results
Primary
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.
Time frame: Up to 12 weeks
Population: Full Analysis Set Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| INCB54707 | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 1 | 2 Participants |
| INCB54707 | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 2 | 2 Participants |
| INCB54707 | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 3 | 0 Participants |
| INCB54707 | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 4 | 0 Participants |
| INCB054707 at 30 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 2 | 2 Participants |
| INCB054707 at 30 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 3 | 0 Participants |
| INCB054707 at 30 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 4 | 0 Participants |
| INCB054707 at 30 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 1 | 6 Participants |
| INCB054707 at 60 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 3 | 0 Participants |
| INCB054707 at 60 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 2 | 2 Participants |
| INCB054707 at 60 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 4 | 0 Participants |
| INCB054707 at 60 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 1 | 4 Participants |
| INCB054707 at 90 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 4 | 0 Participants |
| INCB054707 at 90 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 2 | 3 Participants |
| INCB054707 at 90 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 1 | 1 Participants |
| INCB054707 at 90 mg | Number of Treatment-emergent Adverse Events (TEAEs) | Grade 3 | 3 Participants |
Secondary
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.
Time frame: Up to 12 weeks
Population: Full Analysis Set Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 3 | 3 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 5 | 3 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 4 | 1 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 1 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 2 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 4 | 1 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 2 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 3 | 3 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 2 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 5 | 3 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 5 | 2 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 1 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 5 | 3 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 6 | 2 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 3 | 1 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 4 | 4 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 7 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 1 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 7 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 6 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 7 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 7 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 6 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 7 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 6 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 3 | 3 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 3 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 5 | 2 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 4 | 1 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 3 | 1 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 2 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 2 | 1 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 1 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 4 | 5 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 5 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 6 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 4 | 2 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 5 | 1 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 6 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 4 | 1 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 2 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 1 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 7 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 3 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 7 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 6 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 1 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 2 | 0 Participants |
| INCB54707 | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 1 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 3 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 1 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 2 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 5 | 3 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 3 | 2 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 5 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 7 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 2 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 3 | 2 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 3 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 4 | 3 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 6 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 7 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 1 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 7 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 1 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 4 | 2 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 5 | 2 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 6 | 3 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 7 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 6 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 7 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 3 | 3 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 4 | 2 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 1 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 2 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 3 | 4 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 4 | 2 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 5 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 6 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 7 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 1 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 2 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 4 | 2 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 6 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 1 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 4 | 4 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 5 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 6 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 7 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 1 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 2 | 3 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 5 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 2 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 4 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 5 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 6 | 0 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 2 | 1 Participants |
| INCB054707 at 30 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 3 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 4 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 4 | 3 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 7 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 5 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 5 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 6 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 7 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 6 | 4 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 7 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 5 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 1 | 2 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 6 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 3 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 4 | 2 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 5 | 2 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 4 | 4 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 3 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 6 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 7 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 6 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 1 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 3 | 3 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 4 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 3 | 3 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 2 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 5 | 3 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 1 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 6 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 2 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 7 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 1 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 2 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 2 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 5 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 1 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 2 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 6 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 7 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 2 | 1 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 3 | 3 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 3 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 4 | 4 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 5 | 2 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 1 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 7 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 2 | 2 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 4 | 2 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 1 | 0 Participants |
| INCB054707 at 60 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 3 | 3 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 2 | 3 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 6 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 4 | 3 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 1 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 4 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 1 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 5 | 1 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 7 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 3 | 3 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 7 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 6 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 6 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 1 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 6 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 7 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 6 | 1 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 1 | 1 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 4 | 2 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 1 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 3 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 5 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 4 | 1 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 3 | 1 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 4 | 2 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 2 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 7 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 4 | 2 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 5 | 2 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 5 | 3 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 5 | 3 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 1 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 2 | 3 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 4 | 7 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 3 | 1 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 2 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 5 | 2 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 1 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Follow Up | 7 | 3 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 3 | 2 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 8 | 2 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 6 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 7 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 4 | 4 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 2 | 3 | 1 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 1 | 6 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 3 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 5 | 0 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Week 6 | 2 | 2 Participants |
| INCB054707 at 90 mg | Actual Measurements in HS-PGIC at Each Visit | Early Termination | 2 | 0 Participants |
Secondary
Apparent Oral Clearance of INCB054707
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
Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCB54707 | Apparent Oral Clearance of INCB054707 | 5.27 L/hr | Standard Deviation 2.89 |
Secondary
Apparent Oral Volume of Distribution of INCB054707
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
Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCB54707 | Apparent Oral Volume of Distribution of INCB054707 | 239 L | Standard Deviation 85.7 |
Secondary
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).
Time frame: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Population: Full Analysis Set Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INCB54707 | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Follow Up | 2.6 Units on a scale | Standard Deviation 2.62 |
| INCB54707 | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 4 | -0.3 Units on a scale | Standard Deviation 2.09 |
| INCB54707 | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 1 | 0.2 Units on a scale | Standard Deviation 1.39 |
| INCB54707 | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 6 | 0.0 Units on a scale | Standard Deviation 3.49 |
| INCB54707 | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 2 | -0.1 Units on a scale | Standard Deviation 1.49 |
| INCB54707 | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 8 | 0.3 Units on a scale | Standard Deviation 2.77 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 2 | -1.5 Units on a scale | Standard Deviation 1.18 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 4 | -2.0 Units on a scale | Standard Deviation 2.02 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 6 | -0.9 Units on a scale | Standard Deviation 0.9 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 8 | -2.2 Units on a scale | Standard Deviation 2.18 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Follow Up | -2.7 Units on a scale | Standard Deviation 2.2 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 1 | -0.8 Units on a scale | Standard Deviation 1.13 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 2 | -1.1 Units on a scale | Standard Deviation 0.91 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 1 | -0.3 Units on a scale | Standard Deviation 1.06 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 6 | -2.0 Units on a scale | Standard Deviation 1.55 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 4 | -1.4 Units on a scale | Standard Deviation 1.56 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 8 | -1.4 Units on a scale | Standard Deviation 1.44 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Follow Up | -0.8 Units on a scale | Standard Deviation 0.97 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 1 | -1.5 Units on a scale | Standard Deviation 1.04 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 8 | -3.1 Units on a scale | Standard Deviation 3.28 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 6 | -3.4 Units on a scale | Standard Deviation 3.05 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 2 | -3.3 Units on a scale | Standard Deviation 3.06 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Follow Up | -1.2 Units on a scale | Standard Deviation 1.91 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | Mean change from Baseline to Week 4 | -3.6 Units on a scale | Standard Deviation 3.3 |
Secondary
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.
Time frame: From baseline up to week 8
Population: Full Analysis Set Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCB54707 | Mean Change From Baseline in the Modified Sartorius Scale Score | -36.4 Units on a scale | Standard Deviation 35.83 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Modified Sartorius Scale Score | -41.9 Units on a scale | Standard Deviation 36.84 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Modified Sartorius Scale Score | -59.2 Units on a scale | Standard Deviation 48.48 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Modified Sartorius Scale Score | -54.6 Units on a scale | Standard Deviation 55.42 |
Secondary
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.
Time frame: Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)
Population: Full Analysis Set Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INCB54707 | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 1 | -0.1 Number of Fistulas | Standard Deviation 0.38 |
| INCB54707 | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Follow Up | -0.4 Number of Fistulas | Standard Deviation 3.1 |
| INCB54707 | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 4 | -0.9 Number of Fistulas | Standard Deviation 2.79 |
| INCB54707 | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 8 | -1.0 Number of Fistulas | Standard Deviation 3.06 |
| INCB54707 | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 6 | -1.3 Number of Fistulas | Standard Deviation 2.69 |
| INCB54707 | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 2 | 0.0 Number of Fistulas | Standard Deviation 1.53 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 1 | -0.1 Number of Fistulas | Standard Deviation 1.27 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 8 | -0.3 Number of Fistulas | Standard Deviation 1.66 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Follow Up | 0.1 Number of Fistulas | Standard Deviation 1.69 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 2 | -0.9 Number of Fistulas | Standard Deviation 1.05 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 4 | -0.6 Number of Fistulas | Standard Deviation 1.01 |
| INCB054707 at 30 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 6 | -0.4 Number of Fistulas | Standard Deviation 1.74 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 8 | -2.0 Number of Fistulas | Standard Deviation 3.35 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 2 | -2.1 Number of Fistulas | Standard Deviation 3.48 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 6 | -2.1 Number of Fistulas | Standard Deviation 3.3 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 4 | -2.0 Number of Fistulas | Standard Deviation 3.57 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 1 | -0.8 Number of Fistulas | Standard Deviation 2.39 |
| INCB054707 at 60 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Follow Up | -2.2 Number of Fistulas | Standard Deviation 3.19 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 8 | -0.6 Number of Fistulas | Standard Deviation 3.85 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 6 | -0.6 Number of Fistulas | Standard Deviation 2.72 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 4 | -0.9 Number of Fistulas | Standard Deviation 2.53 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 2 | -0.8 Number of Fistulas | Standard Deviation 2.19 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Week 1 | -0.3 Number of Fistulas | Standard Deviation 0.49 |
| INCB054707 at 90 mg | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Follow Up | -1.3 Number of Fistulas | Standard Deviation 3.86 |
Secondary
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.
Time frame: Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Population: Full Analysis Set Population. Full Analysis Set Population In placebo group 1 participant discontinued the study before week 1, second participant missed all the visits and only had early termination visit. In the 90mg group 1 participant missed week 1 visit and a second participant discontinued before the follow up visit
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 1 | Yes | 1 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 6 | Yes | 3 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 8 | Yes | 4 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 6 | No | 4 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 1 | No | 6 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 4 | Yes | 3 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 4 | No | 4 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Early Termination | Yes | 0 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Follow Up | Yes | 3 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Early Termination | No | 1 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Follow Up | No | 4 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 2 | No | 6 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 2 | Yes | 1 Participants |
| INCB54707 | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 8 | No | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 4 | No | 4 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 8 | Yes | 5 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Early Termination | No | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 6 | Yes | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 2 | Yes | 6 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 2 | No | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Follow Up | Yes | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 6 | No | 6 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 1 | Yes | 1 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Follow Up | No | 6 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 4 | Yes | 5 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 1 | No | 8 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Early Termination | Yes | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 8 | No | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 4 | No | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 1 | No | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 2 | Yes | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 4 | Yes | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Early Termination | Yes | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 1 | Yes | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 2 | No | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 6 | Yes | 6 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 6 | No | 3 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 8 | Yes | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 8 | No | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Follow Up | Yes | 1 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Follow Up | No | 8 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Early Termination | No | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 2 | No | 4 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 2 | Yes | 4 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 4 | Yes | 5 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 1 | No | 5 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Follow Up | Yes | 4 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 1 | Yes | 2 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Early Termination | Yes | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Early Termination | No | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Follow Up | No | 3 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 6 | No | 2 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 6 | Yes | 6 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 4 | No | 3 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 8 | No | 1 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Week 8 | Yes | 7 Participants |
Secondary
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
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)
Population: Full Analysis Set Population In placebo group 1 participant discontinued the study before week 1, second participant missed all the visits and only had early termination visit. In the 90mg group 1 participant missed week 1 visit and a second participant discontinued before the follow up visit
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 2 | Yes | 0 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 8 | No | 3 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 4 | Yes | 2 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 4 | No | 5 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Early Termination | No | 1 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Baseline | No | 9 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 8 | Yes | 4 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Follow Up | Yes | 1 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Follow Up | No | 6 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Baseline | Yes | 0 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 6 | Yes | 3 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 2 | No | 7 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 1 | Yes | 0 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 6 | No | 4 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 1 | No | 7 Participants |
| INCB54707 | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Early Termination | Yes | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 2 | No | 6 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 2 | Yes | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Follow Up | Yes | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Follow Up | No | 6 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 4 | Yes | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 8 | No | 5 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Baseline | No | 9 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Early Termination | Yes | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 4 | No | 6 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 1 | Yes | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Early Termination | No | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 6 | No | 7 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 6 | Yes | 2 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Baseline | Yes | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 1 | No | 9 Participants |
| INCB054707 at 30 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 8 | Yes | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 1 | No | 7 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Follow Up | No | 9 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Early Termination | Yes | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 8 | No | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Early Termination | No | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Follow Up | Yes | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Baseline | Yes | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 1 | Yes | 2 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 8 | Yes | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 2 | No | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 2 | Yes | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 4 | Yes | 6 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 6 | Yes | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 4 | No | 3 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 6 | No | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Baseline | No | 9 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Early Termination | No | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 2 | Yes | 4 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 2 | No | 4 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 4 | No | 3 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 8 | No | 3 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Baseline | No | 7 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 1 | Yes | 2 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 1 | No | 5 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 4 | Yes | 5 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 6 | Yes | 5 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 6 | No | 3 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Week 8 | Yes | 5 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Follow Up | Yes | 4 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Follow Up | No | 3 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Early Termination | Yes | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | Baseline | Yes | 1 Participants |
Secondary
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.
Time frame: Baseline and Week 8
Population: Full Analysis Set Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INCB54707 | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage II | 3 Participants |
| INCB54707 | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage I | 0 Participants |
| INCB54707 | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage I | 1 Participants |
| INCB54707 | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage II | 4 Participants |
| INCB54707 | Proportion of Participants at Each Category of Hurley Stage | Baseline | No HS | 0 Participants |
| INCB54707 | Proportion of Participants at Each Category of Hurley Stage | Week 8 | No HS | 0 Participants |
| INCB54707 | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage III | 3 Participants |
| INCB54707 | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage III | 5 Participants |
| INCB054707 at 30 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage I | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage III | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage I | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage II | 9 Participants |
| INCB054707 at 30 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | No HS | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | No HS | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage II | 6 Participants |
| INCB054707 at 30 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage III | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | No HS | 1 Participants |
| INCB054707 at 60 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage II | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage III | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | No HS | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage I | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage I | 3 Participants |
| INCB054707 at 60 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage II | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage III | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage I | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage III | 1 Participants |
| INCB054707 at 90 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | No HS | 1 Participants |
| INCB054707 at 90 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage II | 7 Participants |
| INCB054707 at 90 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | Stage II | 7 Participants |
| INCB054707 at 90 mg | Proportion of Participants at Each Category of Hurley Stage | Baseline | No HS | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage III | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants at Each Category of Hurley Stage | Week 8 | Stage I | 0 Participants |
Secondary
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.
Time frame: Baseline and Week 8
Population: Full Analysis Set Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | No HS | 0 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage I | 0 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage II | 3 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage III | 3 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage III | 5 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Missing | 2 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage I | 1 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | No HS | 0 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage II | 4 Participants |
| INCB54707 | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Missing | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage I | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage III | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Missing | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage I | 3 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage II | 6 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage II | 9 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | No HS | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage III | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | No HS | 0 Participants |
| INCB054707 at 30 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Missing | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage III | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage III | 4 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage I | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Missing | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | No HS | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | No HS | 1 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage II | 5 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage I | 3 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Missing | 0 Participants |
| INCB054707 at 60 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage II | 5 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | No HS | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage III | 1 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Missing | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage II | 7 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage II | 7 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Missing | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage III | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Baseline | Stage I | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | Stage I | 0 Participants |
| INCB054707 at 90 mg | Proportion of Participants With Change From Baseline Hurley Stage | Week 8 | No HS | 1 Participants |
Secondary
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.
Time frame: Up to 12 weeks
Population: Full Analysis Set Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 5 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 6 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 7 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 5 | 2 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 4 | 1 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 5 | 3 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 6 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 2 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 2 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 1 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 3 | 3 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 3 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 7 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 4 | 4 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 1 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 1 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 6 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 3 | 3 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 4 | 2 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 7 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 6 | 2 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 7 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 2 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 3 | 3 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 3 | 1 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 4 | 1 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 2 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 1 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 5 | 2 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 6 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 1 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 7 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 2 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 7 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 3 | 1 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 4 | 5 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 4 | 1 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 5 | 1 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 2 | 1 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 6 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 5 | 3 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 7 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 1 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 3 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 2 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 6 | 0 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 4 | 1 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 5 | 3 Participants |
| INCB54707 | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 1 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 2 | 3 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 5 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 2 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 6 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 4 | 2 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 5 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 3 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 5 | 3 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 6 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 1 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 4 | 2 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 1 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 2 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 3 | 2 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 5 | 2 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 3 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 1 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 7 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 6 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 4 | 2 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 3 | 4 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 2 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 2 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 4 | 4 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 5 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 3 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 3 | 3 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 4 | 3 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 1 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 7 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 7 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 7 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 6 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 6 | 3 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 7 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 2 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 1 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 1 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 2 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 3 | 2 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 6 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 5 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 7 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 4 | 2 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 6 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 1 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 4 | 0 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 5 | 1 Participants |
| INCB054707 at 30 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 7 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 5 | 2 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 4 | 4 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 5 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 6 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 3 | 3 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 4 | 3 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 5 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 6 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 7 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 1 | 2 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 3 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 6 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 7 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 2 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 3 | 3 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 4 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 1 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 2 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 3 | 3 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 4 | 4 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 5 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 6 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 3 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 4 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 1 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 3 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 4 | 2 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 5 | 2 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 7 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 1 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 2 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 3 | 3 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 7 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 1 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 2 | 2 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 2 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 4 | 2 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 1 | 1 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 5 | 3 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 6 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 7 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 7 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 1 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 2 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 5 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 6 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 7 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 2 | 0 Participants |
| INCB054707 at 60 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 6 | 4 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 4 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 5 | 2 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 3 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 2 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 6 | 1 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 1 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 1 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 5 | 3 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 4 | 2 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 3 | 1 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 4 | 3 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 2 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 3 | 1 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 6 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 1 | 1 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 5 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 4 | 2 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 7 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 2 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 8 | 7 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 4 | 4 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 3 | 2 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 1 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 1 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 6 | 2 | 2 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 7 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 6 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 6 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 3 | 1 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 5 | 2 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 7 | 3 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 6 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 7 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 7 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 3 | 3 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 6 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 7 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 2 | 3 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 2 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 1 | 1 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 1 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 5 | 3 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 4 | 1 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 6 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 2 | 3 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 2 | 5 | 1 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Week 4 | 4 | 2 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Follow Up | 3 | 0 Participants |
| INCB054707 at 90 mg | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | Early Termination | 5 | 0 Participants |