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The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib Cream | Experimental | Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension. |
|
| Vehicle Cream | Experimental | Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib cream | Drug | Ruxolitinib cream is a topical formulation applied as a thin film to affected areas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | Baseline; Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, in AN count relative to Baseline. | Baseline; Week 16 |
| Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline |
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Inclusion Criteria:
Diagnosis of HS based on clinical history and physical examination for at least 3 months.
Diagnosis of HS (Hurley I or II) with the following:
AN of 3 should affect at least 1 distinct anatomical area
AN of > 3 to ≤ 10 should affect at least 2 distinct anatomical areas.
Baseline Skin Pain or Itch NRS score ≥ 1.
Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study.
Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
Presence of draining tunnels at screening or at baseline visits.
Concurrent conditions and history of other diseases:
Laboratory values outside of the protocol-defined criteria.
Use of any prohibited medications per protocol-defined criteria.
Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
Other exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists Phoenix | Phoenix | Arizona | 85006 | United States | ||
| First Oc Dermatology |
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted at 19 study centers in Canada and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks. |
| FG001 | DBVC Period: Vehicle Cream BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 16-Week DBVC Period |
|
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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 | Aug 19, 2022 | Oct 4, 2024 |
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Participants will be randomized 1:1 to 1 of 2 treatment groups (ruxolitinib 1.5% cream BID or vehicle cream BID).
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| Vehicle cream | Drug | Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream. |
|
Pre-existing ANs at Baseline were defined as abscesses and/or inflammatory nodules present at Baseline. All new ANs identified during the study in an anatomical area that had pre-existing ANs at Baseline were counted. Any new ANs identified in an anatomical area that was initially free of ANs at Baseline were not counted. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. |
| Baseline; Week 16 |
| Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16 | The Skin Pain NRS is a daily participant-reported measure (24-hour recall) of the worst level of skin pain related to Hidradenitis Suppurativa. The participants rated the pain severity of their Hidradenitis Suppurativa by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described their worst level of pain in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | Baseline; Week 16 |
| Change From Baseline in Itch NRS Score at Week 16 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity related to Hidradenitis Suppurativa. The participants rated the itch severity of their Hidradenitis Suppurativa by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | Baseline; Week 16 |
| Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | HiSCR was defined as at least a 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to Baseline. | Baseline; Week 16 |
| Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. IHS4 score was calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). Scores: mild=0-3; moderate=4-10; severe ≥11. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | Baseline; Week 16 |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | up to Week 16 plus 30 days |
| Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | up to Week 16 plus 30 days |
| Number of Participants With Any TEAE in the Open-label Extension (OLE) Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | from Week 17 up to Week 32 plus 30 days |
| Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | from Week 17 up to Week 32 plus 30 days |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Skin Care Research, Llc Scr Hollywood | Boca Raton | Florida | 33486 | United States |
| Forcare Clinical Research | Tampa | Florida | 33613 | United States |
| Marietta Dermatology the Skin Cancer Center Marietta | Marietta | Georgia | 30060-1047 | United States |
| Delricht Research | Baton Rouge | Louisiana | 70809 | United States |
| Delricht Research | New Orleans | Louisiana | 70115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Revival Research Institute, Llc Troy | Troy | Michigan | 48084 | United States |
| Dr Bobby Buka, Md Greenwich Village | New York | New York | 10012-1354 | United States |
| Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | 37130 | United States |
| Austin Institute For Clinical Research Aicr Pflugerville | Pflugerville | Texas | 78660 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Wiseman Dermatology Research Inc | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Dr.Wei Jing Loo Medicine Professional Corp | London | Ontario | N6H 5L4 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X2 | Canada |
| Skin Centre For Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| Xlr8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
Participants applied matching vehicle cream BID for 16 weeks.
| FG002 | Open-label Extension (OLE) Period: Ruxolitinib 1.5% Cream BID | Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID for an additional 16 weeks in the OLE Period. |
| FG003 | OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID for 16 weeks in the OLE Period. |
| COMPLETED |
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| NOT COMPLETED |
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| 16-Week OLE Period |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks. |
| BG001 | DBVC Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 16 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to treatment assignment at randomization. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | ANs | Baseline; Week 16 |
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| Secondary | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, in AN count relative to Baseline. | ITT Population. Only participants with available data were analyzed. | Posted | Number | percentage of participants | Baseline; Week 16 |
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| Secondary | Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline | Pre-existing ANs at Baseline were defined as abscesses and/or inflammatory nodules present at Baseline. All new ANs identified during the study in an anatomical area that had pre-existing ANs at Baseline were counted. Any new ANs identified in an anatomical area that was initially free of ANs at Baseline were not counted. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | ANs | Baseline; Week 16 |
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| Secondary | Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16 | The Skin Pain NRS is a daily participant-reported measure (24-hour recall) of the worst level of skin pain related to Hidradenitis Suppurativa. The participants rated the pain severity of their Hidradenitis Suppurativa by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described their worst level of pain in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline; Week 16 |
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| Secondary | Change From Baseline in Itch NRS Score at Week 16 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity related to Hidradenitis Suppurativa. The participants rated the itch severity of their Hidradenitis Suppurativa by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline; Week 16 |
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| Secondary | Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | HiSCR was defined as at least a 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to Baseline. | ITT Population. Only participants with available data were analyzed. | Posted | Number | percentage of participants | Baseline; Week 16 |
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| Secondary | Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. IHS4 score was calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). Scores: mild=0-3; moderate=4-10; severe ≥11. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline; Week 16 |
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| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group. | Posted | Count of Participants | Participants | up to Week 16 plus 30 days |
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| Secondary | Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | Safety Population | Posted | Count of Participants | Participants | up to Week 16 plus 30 days |
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| Secondary | Number of Participants With Any TEAE in the Open-label Extension (OLE) Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | Open-label Extension Safety Population: all participants who applied ruxolitinib 1.5% cream BID at least once during the OLE Period | Posted | Count of Participants | Participants | from Week 17 up to Week 32 plus 30 days |
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| Secondary | Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | Open-label Extension Safety Population | Posted | Count of Participants | Participants | from Week 17 up to Week 32 plus 30 days |
|
up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle Cream BID | Participants applied matching vehicle cream twice a day (BID) for 16 weeks in the Double-blind, Vehicle-controlled Period. | 0 | 35 | 1 | 35 | 2 | 35 |
| EG001 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream BID during the Double-blind, Vehicle-controlled (DBVC) Period and the Open-label Extension (OLE) Period. Participants applied ruxolitinib 1.5% cream BID for 16 weeks in the DBVC Period. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID for an gadditional 16 weeks in the OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID for 16 weeks in the OLE Period. | 0 | 66 | 2 | 66 | 5 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2023 | Oct 4, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| Lost to Follow-up |
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| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Pregnancy |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black/African-American |
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| Asian |
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| Unknown |
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| Mixed Race: Black and White |
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| White and American Indian/Alaska Native |
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| Half White, Half Asian |
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| Metis, White |
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| North African |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID for 16 weeks in the OLE Period.
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