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The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib cream | Experimental | Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension. |
|
| Vehicle Cream | Placebo Comparator | Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-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 |
|---|---|---|
| Percentage of Participants With ITCH4 at Week 12 | ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours. | Baseline; Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | The CLISSCO is a validated tool to assess disease severity in vulvar lichen sclerosus. The Clinical Lichen Sclerosus Score consists of 12 items divided into 3 sections: symptoms (3 items; likely reversible [i.e., itch, pain, dysuria]); signs (3 items; possibly reversible [i.e., whitening, petechiae/ecchymosis, fissures]); and architectural changes (6 items; irreversible [i.e., skin fusion, perianal involvement, etc.]). All symptoms, signs, and architectural changes were rated on a 4-point Likert scale: 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). The investigator documented the score of each of the 12 items; the CLISSCO was calculated by summing the score of each question, with a maximum score of 36 and a minimum score of 0. The higher the score, the more severe the disease. Additionally, the total score for each of the 3 sections (symptoms, signs, and architectural changes) was summarized by summing the scores of the questions in each section. |
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Inclusion Criteria:
Exclusion Criteria:
Participants who do not have LS involving anogenital area.
Concurrent conditions and history of other diseases:
Laboratory values outside of the protocol-defined criteria
Pregnant or lactating participants or those considering pregnancy during the period of their study participation..
Other exclusion criteria may apply.
Females aged 18 years or older at screening with a biopsy confirmed diagnosis of Lichen Sclerosus
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| Name | Affiliation | Role |
|---|---|---|
| Haq Nawaz, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology | Birmingham | Alabama | 35244 | United States | ||
| Mayo Clinic - Scottsdale |
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.
A total of 61 participants were randomized into the study. All randomized participants (Intent-to-Treat Population) applied study drug at least once (Safety Population), and 56 participants applied ruxolitinib 1.5% cream at least once during the Open-label Extension (OLE) Period (OLE-Evaluable Population).
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks. |
| FG001 | DBVC Period: Vehicle Cream BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 12-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 | Dec 18, 2023 | Aug 29, 2024 |
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Study will be a 12 week double-blind period followed by a 12 week open label period.
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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. |
|
| Baseline; Week 12 |
| Change From Baseline in the Skin Pain NRS Score at Week 12 | Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 12 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen sclerosus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. | Baseline; Week 12 |
| Time to Achieve ITCH4 | ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours. | up to 99.0 days |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled 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 an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. | from Baseline to Week 12 plus 30 days |
| Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | A TEAE was defined as an AE either 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 the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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 Baseline to Week 12 plus 30 days |
| Number of Participants With Any TEAE During the Open-label Extension 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 an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. | from Week 12 to Week 24 plus 30 days |
| Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | A TEAE was defined as an AE either 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 the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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 12 to Week 24 plus 30 days |
| Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | The investigator determined if a clinical laboratory test value was clinically meaningful. | from Baseline to Week 12 plus 30 days |
| Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | The investigator determined if a clinical laboratory test value was clinically meaningful. | from Baseline to Week 12 plus 30 days |
| Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period | The investigator determined if a clinical laboratory test value was clinically meaningful. | from Week 12 to Week 24 plus 30 days |
| Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period | The investigator determined if a clinical laboratory test value was clinically meaningful. | from Week 12 to Week 24 plus 30 days |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| UC Irvine | Irvine | California | 92697 | United States |
| The Centers For Vulvovaginal Disorders | Washington D.C. | District of Columbia | 20037 | United States |
| New Age Medical Research Corporation | Miami | Florida | 33186 | United States |
| Circuit Clinical | West Seneca | New York | 14224 | United States |
| Unc Dermatology and Skin Cancer Center At Southern Village | Chapel Hill | North Carolina | 27516 | United States |
| Apex Dermatology | Ashtabula | Ohio | 44004 | United States |
| Bexley Dermatology | Bexley | Ohio | 43209 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Utah Health Care Midvalley Health Center Dermatology | Murray | Utah | 84107 | United States |
| Seattle Skin and Laser Clinic | Seattle | Washington | 98105 | United States |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Clinique Rsf | Québec | Quebec | G1V 3M7 | Canada |
Participants applied matching vehicle cream BID for 12 weeks.
| FG002 | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Participants who completed the Week 12 assessments with no safety concerns could continue into the 12-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 12 weeks in the Open-label Extension Period. Participants could have cycled between once daily (QD) or BID application of ruxolitinib 1.5% cream based on the investigator's clinical judgment of disease activity. |
| FG003 | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 12 assessments with no safety concerns could continue into the 12-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 12 weeks in the Open-label Extension Period. Participants could have cycled between QD or BID application of ruxolitinib 1.5% cream based on the investigator's clinical judgment of disease activity. |
| COMPLETED |
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| NOT COMPLETED |
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| 12-Week Open-Label Extension Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | DBVC Period: Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks. |
| BG001 | DBVC Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | Percentage of Participants With ITCH4 at Week 12 | ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours. | Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might have taken. Only those participants with a Baseline ITCH NRS Score ≥4 were analyzed. Missing post-baseline values were imputed as Non-Responders at Week 12. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Week 12 |
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| Secondary | Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | The CLISSCO is a validated tool to assess disease severity in vulvar lichen sclerosus. The Clinical Lichen Sclerosus Score consists of 12 items divided into 3 sections: symptoms (3 items; likely reversible [i.e., itch, pain, dysuria]); signs (3 items; possibly reversible [i.e., whitening, petechiae/ecchymosis, fissures]); and architectural changes (6 items; irreversible [i.e., skin fusion, perianal involvement, etc.]). All symptoms, signs, and architectural changes were rated on a 4-point Likert scale: 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). The investigator documented the score of each of the 12 items; the CLISSCO was calculated by summing the score of each question, with a maximum score of 36 and a minimum score of 0. The higher the score, the more severe the disease. Additionally, the total score for each of the 3 sections (symptoms, signs, and architectural changes) was summarized by summing the scores of the questions in each section. | ITT Population. Only participants with available data were analyzed. Mixed Model Repeated Measures (MMRM) model: response variable = treatment + visit + treatment by visit. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline; Week 12 |
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| Secondary | Change From Baseline in the Skin Pain NRS Score at Week 12 | Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 12 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen sclerosus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. | ITT Population. Only participants with available data were analyzed. No imputation was performed for missing values. MMRM model: response variable = treatment + visit + treatment by visit. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline; Week 12 |
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| Secondary | Time to Achieve ITCH4 | ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours. | ITT Population. Only those participants achieving a ≥4-point improvement in daily Itch NRS score from Baseline were analyzed. | Posted | Median | 95% Confidence Interval | days | up to 99.0 days |
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| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled 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 an AE either 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 for this population were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group. | Posted | Count of Participants | Participants | from Baseline to Week 12 plus 30 days |
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| Secondary | Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | A TEAE was defined as an AE either 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 the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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 | from Baseline to Week 12 plus 30 days |
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| Secondary | Number of Participants With Any TEAE During the Open-label Extension 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 an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. | Open-label Extension Evaluable Population: all participants who applied ruxolitinib 1.5% cream at least once during the Open-label Extension Period | Posted | Count of Participants | Participants | from Week 12 to Week 24 plus 30 days |
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| Secondary | Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | A TEAE was defined as an AE either 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 the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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 Evaluable Population | Posted | Count of Participants | Participants | from Week 12 to Week 24 plus 30 days |
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| Secondary | Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | The investigator determined if a clinical laboratory test value was clinically meaningful. | Safety Population | Posted | Count of Participants | Participants | from Baseline to Week 12 plus 30 days |
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| Secondary | Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | The investigator determined if a clinical laboratory test value was clinically meaningful. | Safety Population | Posted | Count of Participants | Participants | from Baseline to Week 12 plus 30 days |
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| Secondary | Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period | The investigator determined if a clinical laboratory test value was clinically meaningful. | Open-label Extension Evaluable Population | Posted | Count of Participants | Participants | from Week 12 to Week 24 plus 30 days |
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| Secondary | Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period | The investigator determined if a clinical laboratory test value was clinically meaningful. | Open-label Extension Evaluable Population | Posted | Count of Participants | Participants | from Week 12 to Week 24 plus 30 days |
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up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
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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 | Ruxolitinib Cream 1.5% BID | Participants who completed the Week 12 assessments with no safety concerns, continued into the 12-week Open-label Extension Period, and applied ruxolitinib cream 1.5% BID for 12 weeks in the Open-label Extension Period. | 0 | 58 | 0 | 58 | 10 | 58 |
| EG001 | Vehicle Cream BID | Participants applied matching vehicle cream twice a day (BID) for 12 weeks in the Double-Blind Period. | 0 | 30 | 1 | 30 | 6 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 26.1 | 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 | Aug 24, 2023 | Aug 29, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018459 | Lichen Sclerosus et Atrophicus |
| D012871 | Skin Diseases |
| D014845 | Vulvar Diseases |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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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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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| response rate difference |
| -4.3 |
| Standard Error of the Mean |
| 12.73 |
| 2-Sided |
| 95 |
| -29.2 |
| 20.7 |
The 95% confidence interval for the response rate difference was constructed from approximately normal distribution. |
| Superiority |
Participants applied matching vehicle cream BID for 12 weeks.
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