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This is a randomized, double blind, vehicle controlled Phase 2 study with a 4-week open label extension in adolescent and adult participants with atopic dermatitis and head and/or neck involvement. It is intended to compare the efficacy and safety of ruxolitinib cream 1.5% BID versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open label extension period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID | Experimental | Participants will be treated with ruxolitinib cream 1.5% or vehicle cream twice a day (BID) in a double-blind fashion. |
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| Open Label Extension: Ruxolitiib cream 1.5% | Experimental | Patients will be treated with Ruxoltinib cream 1.5% twice per day (BID) during the open label extension period. Participants who complete the double-blind period will continue into this open-label extension period for an additional 4 weeks of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib cream | Drug | Ruxolitinib cream 1.5% applied twice a day (BID)" |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) of the Head and Neck Region at Week 4 | The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck. | Baseline; Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8 | The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck. |
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Inclusion Criteria:
Participants with diagnosis of AD for at least 6 months.
Participants with an overall and a face and/or neck IGA score of 2 or 3 at screening and baseline.
Participants with AD affecting the following at screening and baseline:
Willingness to avoid pregnancy or fathering children based on the criteria outlined in the protocol.
Further inclusion criteria apply.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haq Nawaz, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Science37 | Culver City | California | 90230 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40132224 | Derived | Chiesa Fuxench ZC, Lai Z, Kuo Y, Nawaz H, Cotliar J. Ruxolitinib cream monotherapy for facial and/or neck atopic dermatitis: results from a decentralized, randomized phase 2 clinical trial. J Dermatolog Treat. 2025 Dec;36(1):2480744. doi: 10.1080/09546634.2025.2480744. Epub 2025 Mar 25. |
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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 decentralized clinical study was conducted through 1 virtual meta-site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 4 weeks. |
| FG001 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks. |
| FG002 | Open-Label Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 4 assessments with no safety concerns could continue into the 4-week Open-Label Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 4 weeks in the Open-Label Period. |
| FG003 | Open-Label Period: Ruxolitinib Cream 1.5% BID | Participants who completed the Week 4 assessments with no safety concerns could continue into the 4-week Open-Label Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 4 weeks in the Open-Label Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4-Week Double-Blind Period |
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| 4-Week Open-Label Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 4 weeks. |
| BG001 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks. |
| 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 | Percentage of Participants Who Achieve a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) of the Head and Neck Region at Week 4 | The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck. | Full Analysis Population: all participants enrolled in the study who had at least 1 application of study drug. Missing post-Baseline values were imputed as Non-Responders at Week 4. The 95% confidence interval for the difference was computed based on a large-sample normal approximation with continuity correction. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Week 4 |
from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 8 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of pre-existing events after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Full Analysis Population: all participants who had at least 1 application of study drug.. For the Open-Label Period, TEAEs are reported for the Open-Label Evaluable Population: all participants who applied at least 1 dose of ruxolitinib cream during the Open-Label Period.
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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 | Vehicle Cream BID | Participants applied matching vehicle cream twice a day (BID) for 4 weeks in the Double-Blind Period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site reaction | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | Aug 4, 2022 | Jul 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2023 | Jul 15, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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This is 2:1 assignment to rux and vehicle creams.
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4 week double-blind treatment
| Vehicle | Drug | Vehicle cream applied twice a day (BID) to affected areas |
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| Baseline; Weeks 2 and 8 |
| Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8 | The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score. | Baseline; Weeks 2, 4, and 8 |
| Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | A TEAE was defined as any adverse event (AE) either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was 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. | up to approximately 4 weeks plus 30 days |
| Open-Label Period: Number of Participants With Any TEAE | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was 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. | from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days) |
| Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. The severity of AEs was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grades 1 to 5). Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. | up to approximately 4 weeks plus 30 days |
| Open-Label Period: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was 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. | from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days) |
| Physician Decision |
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| Withdrawal by Subject |
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| Withdrawn by Sponsor |
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| Withdrawn Due to E-diary Compliance |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| 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/Ethnicity, Customized | Count of Participants | Participants |
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| Secondary | Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8 | The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck. | Full Analysis Population. Only participants with available data were analyzed. The 95% confidence interval for the difference was computed based on a large-sample normal approximation with continuity correction. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Weeks 2 and 8 |
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| Secondary | Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8 | The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score. | Full Analysis Population. Only participants with available data were analyzed. The 95% confidence interval for the difference was computed based on a large-sample normal approximation with continuity correction. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Weeks 2, 4, and 8 |
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| Secondary | Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | A TEAE was defined as any adverse event (AE) either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was 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. | Full Analysis Population | Posted | Count of Participants | Participants | up to approximately 4 weeks plus 30 days |
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| Secondary | Open-Label Period: Number of Participants With Any TEAE | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was 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. | Open-Label Evaluable Population: all participants who applied at least 1 dose of ruxolitinib cream during the Open-Label Period | Posted | Count of Participants | Participants | from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days) |
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| Secondary | Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. The severity of AEs was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grades 1 to 5). Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. | Full Analysis Population | Posted | Count of Participants | Participants | up to approximately 4 weeks plus 30 days |
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| Secondary | Open-Label Period: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was 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. | Open-Label Evaluable Population | Posted | Count of Participants | Participants | from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days) |
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| 0 |
| 23 |
| 0 |
| 23 |
| 2 |
| 23 |
| EG001 | Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib cream during the Double-Blind Period and the Open-Label Period. Participants who completed the Week 4 assessments with no safety concerns could continue into the 4-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 4 weeks in the Open-Label Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 4 weeks in the Open-Label Period. | 0 | 71 | 0 | 71 | 1 | 71 |
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.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Week 8 |
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| Week 4 |
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| Week 8 |
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