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The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB054707 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB054707 | Drug | INCB054707 administered once daily orally with water without regard to food for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to approximately 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent Oral Clearance of INCB054707(CL/F) | To evaluate the systemic exposure to INCB054707. | Postdose Day1, week 2 and 6 |
| Apparent Oral Volume of Distribution of INCB054707(Vc/F) | To evaluate the systemic exposure to INCB054707. |
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Inclusion Criteria:
Exclusion Criteria:
Women of childbearing potential or who are currently pregnant or lactating.
Presence of > 20 draining fistulas at screening and baseline.
Participants with concurrent conditions or history of other diseases as follows:
Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
Positive test result for tuberculosis (TB) from the QuantiFERON-TB Gold test, or equivalent, at screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening) or a history of active TB.
Positive serology test results for HIV, HBsAg, hepatitis B virus (HBV) core antibody, or HCV (HCV antibody with positive HCV-RNA) at screening.
Decreased blood cell counts at screening as per protocol-defined parameters.
Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 1.5 × upper limit of normal (ULN).
Impaired renal function with serum creatinine > 1.5 mg/dL.
Use of prohibited medications per protocol-defined criteria.
Known or suspected allergy to INCB054707 or any component of the study drug.
Known history of clinically significant drug or alcohol abuse in the last year prior to baseline.
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Butler, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Los Angeles | California | 90045 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34978076 | Derived | Alavi A, Hamzavi I, Brown K, Santos LL, Zhu Z, Liu H, Howell MD, Kirby JS. Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase II studies. Br J Dermatol. 2022 May;186(5):803-813. doi: 10.1111/bjd.20969. Epub 2022 Mar 6. |
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A total of 10 participants were assigned to treatment with INCB054707.
The study was conducted at 4 different sites in US.
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| ID | Title | Description |
|---|---|---|
| FG000 | INCB054707 | Participants were treated with 15 mg QD of INCB054707 orally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | INCB054707 | Participants were treated with 15 mg QD of INCB054707 orally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Number | Participants | Up to approximately 12 weeks. |
|
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Up to approximately 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INCB054707 | Participants were treated with 15 mg QD of INCB054707 orally. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center, Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2018 | Apr 22, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2018 | Apr 22, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Postdose Day1, week 2 and 6. |
| Absorption Constant of INCB054707 (Ka) | Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707. | Postdose Day1, week 2 and 6. |
| Apparent Inter-compartmental Clearance(Q/F) | Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707. | Postdose Day1, week 2 and 6. |
| Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | An HiSCR is 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 at each visit. | Weeks 1,2,4,6,8 and FollowUp |
| Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | The number and proportion of participants who achieved an Abscess and Inflammatory nodule count of 0 to 2 progressively. | Weeks 1,2,4,6,8 and FollowUp |
| Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit | The HS Pain NRS will be completed in a daily diary by participants from screening through EOS. An 11-point scale will be used to assess the worst skin pain due to HS based on a recall period of the last 24 hours. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) | Weeks 1,2,4,6,8 and FollowUp |
| 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. | Week 8. |
| Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit | Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. | Up to approximately 12 weeks. |
| Proportion of Participants at Each Category of Hurley Stage | The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. | Baseline and Week 8. |
| Proportion of Participants With Change From Baseline to Week 8 in 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. | Week 8. |
| Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category | The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse. | Up to approximately 12 weeks. |
| Proportion of Participants Requiring Rescue Lesional Treatment | Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion. | Up to approximately 12 weeks. |
| Number of Interventions With Rescue Lesional Treatment | Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion. | Up to approximately 12 weeks. |
| Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit | The DLQI is a questionnaire used to assess the symptoms and the impact of skin problems on quality of life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The meaning of DLQI scores can be categorized as follows: 0-1 = No effect at all on patient's life 2-5 = Small effect on patient's life 6-10 = Moderate effect on patient's life 11-20 = Very large effect on patient's life 21-30 = Extremely large effect on patient's life | Up to approximately 12 weeks. |
| Tampa |
| Florida |
| 33624 |
| United States |
| Investigative Site | New York | New York | 10065 | United States |
| Investigative Site | Hershey | Pennsylvania | 17033 | United States |
| Number |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | Apparent Oral Clearance of INCB054707(CL/F) | To evaluate the systemic exposure to INCB054707. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Postdose Day1, week 2 and 6 |
|
|
|
| Secondary | Apparent Oral Volume of Distribution of INCB054707(Vc/F) | To evaluate the systemic exposure to INCB054707. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Postdose Day1, week 2 and 6. |
|
|
|
| Secondary | Absorption Constant of INCB054707 (Ka) | Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hr | Postdose Day1, week 2 and 6. |
|
|
|
| Secondary | Apparent Inter-compartmental Clearance(Q/F) | Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Postdose Day1, week 2 and 6. |
|
|
|
| Secondary | Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | An HiSCR is 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 at each visit. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Count of Participants | Participants | Weeks 1,2,4,6,8 and FollowUp |
|
|
|
| Secondary | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | The number and proportion of participants who achieved an Abscess and Inflammatory nodule count of 0 to 2 progressively. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Count of Participants | Participants | Weeks 1,2,4,6,8 and FollowUp |
|
|
|
| Secondary | Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit | The HS Pain NRS will be completed in a daily diary by participants from screening through EOS. An 11-point scale will be used to assess the worst skin pain due to HS based on a recall period of the last 24 hours. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Mean | Standard Deviation | Units on a Scale | Weeks 1,2,4,6,8 and FollowUp |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a Scale | Week 8. |
|
|
|
| Secondary | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit | Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Mean | Standard Deviation | Number of Fistulas | Up to approximately 12 weeks. |
|
|
|
| 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. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Count of Participants | Participants | Baseline and Week 8. |
|
|
|
| Secondary | Proportion of Participants With Change From Baseline to Week 8 in 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. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Count of Participants | Participants | Week 8. |
|
|
|
| Secondary | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category | 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. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Count of Participants | Participants | Up to approximately 12 weeks. |
|
|
|
| Secondary | Proportion of Participants Requiring Rescue Lesional Treatment | Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Count of Participants | Participants | Up to approximately 12 weeks. |
|
|
|
| Secondary | Number of Interventions With Rescue Lesional Treatment | Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Mean | Standard Deviation | Interventions | Up to approximately 12 weeks. |
|
|
|
| Secondary | Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit | The DLQI is a questionnaire used to assess the symptoms and the impact of skin problems on quality of life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The meaning of DLQI scores can be categorized as follows: 0-1 = No effect at all on patient's life 2-5 = Small effect on patient's life 6-10 = Moderate effect on patient's life 11-20 = Very large effect on patient's life 21-30 = Extremely large effect on patient's life | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Count of Participants | Participants | Up to approximately 12 weeks. |
|
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| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Clinical Study Agreement
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| Week 4 |
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| Stage III |
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| No HS |
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| Week 8 |
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| Stage II |
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| Stage III |
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| Week 8 |
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| 3 |
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| Week 6 |
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| Follow Up |
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| 6-10 |
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| 11-20 |
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| 21-30 |
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| Week 1 |
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