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The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib (1.5% Cream) | Experimental | Study drug will be administered twice daiily. |
|
| Ruxolitinib (0.75% cream) | Experimental | Study drug will be administered twice daily. |
|
| Vehicle Cream | Placebo Comparator | Vehicle cream will be administered twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | The study cream will be applied topically twice a day for up to 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 | The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit.
Concurrent conditions and history of other diseases as follows:
Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would 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.
Use of any of the following treatments within the indicated washout period before the baseline visit:
Participants who have previously received JAK inhibitors, systemic or topical. -Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.-
Positive serology test results at screening for HIV antibody.
Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.
Employees of the sponsor or investigator or otherwise dependents of them.
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| Name | Affiliation | Role |
|---|---|---|
| Brett Angel, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Cahaba Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40378883 | Derived | Eichenfield LF, Stein Gold LF, Simpson EL, Zaenglein AL, Armstrong AW, Tollefson MM, Soong W, Wine Lee L, Devani AR, Forman SB, Siri DD, Kallender H, Angel B, Li Q, Chen X, Paller AS. Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study. J Am Acad Dermatol. 2025 Sep;93(3):689-698. doi: 10.1016/j.jaad.2025.05.1385. Epub 2025 May 14. |
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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.
Participants who completed Week 8 assessments of the Vehicle-controlled (VC) Period with no safety concerns continued in the 44-week Long-term Safety (LTS) Period. Participants who were on active treatment during the VC Period continued with the same treatment regimen in the LTS Period, and those who applied vehicle cream during the VC Period were equally randomized into 1 of the 2 active treatment groups (ruxolitinib 0.75%, ruxolitinib 1.5%) cream during the LTS Period.
A total of 330 participants were enrolled at 48 study centers in the United States and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | VC Period: Vehicle Cream BID | Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| VC Period (Day 1 to Week 8) |
|
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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 | Feb 23, 2023 | May 8, 2024 |
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| Vehicle Cream | Drug | Matching vehicle cream will be applied topically twice a day for up to 8 weeks. |
|
|
| Baseline to Week 8 |
| VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1) | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. | Baseline to Day 7 (Week 1) |
| VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. | Baseline to Day 3 |
| VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event 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 be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. | from Baseline up to Week 8 |
| LTS Period: Number of Participants With Any TEAE | An adverse event 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 be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. | From Week 8 up to Week 56 |
| VC Period: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (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 Baseline up to Week 8 |
| LTS Period: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (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 up to Week 56 |
| VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4 | The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline. | Baseline to Weeks 2 and 4 |
| VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD 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. | Baseline to Weeks 2 and 4 |
| VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (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 ≥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), each 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 to Weeks 2, 4, and 8 |
| VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points | The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses. | up to Week 8 |
| Hoover |
| Alabama |
| 35244 |
| United States |
| Physicians Research Group Ii | Gilbert | Arizona | 85295 | United States |
| Cct Research With Center For Dermatology and Plastic Surgery | Scottsdale | Arizona | 85260 | United States |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States |
| First Oc Dermatology | Fountain Valley | California | 92708 | United States |
| Iact Health | Los Angeles | California | 90017 | United States |
| Metropolis Dermatology | Los Angeles | California | 90017 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Madera Family Medical Group | Madera | California | 93637 | United States |
| Allergy & Asthma Associates of Southern California | Mission Viejo | California | 92691 | United States |
| Palmtree Clinical Research-Clinedge-Ppds | Palm Springs | California | 92262 | United States |
| Integrated Research of Inland, Inc | Riverside | California | 92506 | United States |
| Clinical Science Institute Clinical Research Specialists Inc | Santa Monica | California | 90404 | United States |
| Phdermatology | Clearwater | Florida | 33756 | United States |
| Life Clinical Trials Margate | Margate | Florida | 33063 | United States |
| Acevedo Clinical Research | Miami | Florida | 33142 | United States |
| Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc | Miami | Florida | 33146 | United States |
| The Childrens Skin Center Csc Miami | Miami | Florida | 33155 | United States |
| Entrust Clinical Research | Miami | Florida | 33156 | United States |
| Ciocca Dermatology Pa | Miami | Florida | 33173 | United States |
| Forcare Clinical Research | Tampa | Florida | 33624 | United States |
| Aeroallergy Research Lab of Savannah | Savannah | Georgia | 31406 | United States |
| Northwestern Memorial Hospital-Arkes Pavilion | Chicago | Illinois | 60611 | United States |
| Sneeze Wheeze and Itch Associates Llc | Normal | Illinois | 61761 | United States |
| Northshore Medical Group Dermatology Skokie | Skokie | Illinois | 60076 | United States |
| Dermatology Specialists Research Indiana | Clarksville | Indiana | 47129 | United States |
| Dawes Fretzin Clinical Research Group Llc | Indianapolis | Indiana | 46250 | United States |
| Kansas City Dermatology P.A. | Lenexa | Kansas | 66215 | United States |
| Office of Michael W. Simon, Md | Nicholasville | Kentucky | 40356 | United States |
| Meridian Clinical Research | Baton Rouge | Louisiana | 70808 | United States |
| Delricht Clinical Research-Clinedge-Ppds Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Delricht Research-Touro Medical Center | New Orleans | Louisiana | 70115 | United States |
| Lawrence J. Green, Md. Llc | Rockville | Maryland | 20850 | United States |
| Henry Ford Medical Center-New Center One | Detroit | Michigan | 48202 | United States |
| Michigan Dermatology Institute | Waterford | Michigan | 48328 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Skin Specialists Pc the Advanced Skin Research Center | Omaha | Nebraska | 68144 | United States |
| Dr Bobby Buka, Md Greenwich Village | New York | New York | 10012 | United States |
| New York University Langone Medical Center-Fink Children'S Ambulatory Care Center | New York | New York | 10016 | United States |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | United States |
| Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc | Grants Pass | Oregon | 97527 | United States |
| Cyn3Rgy Research-Clinedge-Ppds | Gresham | Oregon | 97030 | United States |
| Velocity Clinical Research-Medford | Medford | Oregon | 97504 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Knight Cancer Institute At Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | 37130 | United States |
| Arlington Research Center | Arlington | Texas | 76011 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Texas Dermatology Alamo Heights Office | San Antonio | Texas | 78218 | United States |
| Allergy and Asthma Care of Waco, Pa | Waco | Texas | 76712 | United States |
| Intermountain Clinical Research Icr Draper | Draper | Utah | 84020 | United States |
| Springville Dermatology | Springville | Utah | 84663 | United States |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | United States |
| Skindc Clinic | Arlington | Virginia | 22209 | United States |
| Pi Coor Clinical Research Llc | Burke | Virginia | 22015 | United States |
| Clinical Research Partners Llc | Richmond | Virginia | 23220 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Children'S Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Dermatology Research Institute | Calgary | Alberta | T3A 2N1 | Canada |
| Leader Research | Hamilton | Ontario | L8L 3C3 | Canada |
| Dermatology Ottawa Research Centre | Ottawa | Ontario | K2C 3N2 | Canada |
| VC Period: Ruxolitinib 0.75% Cream BID |
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| FG002 | VC Period: Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| FG003 | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| FG004 | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| FG005 | LTS Period: Ruxolitinib 0.75% Cream BID | Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| FG006 | LTS Period: Ruxolitinib 1.5% Cream BID | Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| COMPLETED |
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| NOT COMPLETED |
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| LTS Period (Weeks 8 to 52) |
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| ID | Title | Description |
|---|---|---|
| BG000 | VC Period: Vehicle Cream BID | Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| BG001 | VC Period: Ruxolitinib 0.75% Cream BID | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| BG002 | VC Period: Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| BG003 | 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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 | The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline. | Intent-to-Treat (ITT) Population: all participants who were randomized to the study. Treatment groups for this population were defined according to the treatment assignment at the time of randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Week 8 |
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| Secondary | VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. | ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Week 8 |
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| Secondary | VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1) | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. | ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis. Missing Day 7 Itch scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors, Baseline, and post-Baseline Day 1 to Day 7 Itch NRS Score as predicators. | Posted | Number | percentage of participants | Baseline to Day 7 (Week 1) |
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| Secondary | VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. | ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis. Missing Day 3 Itch scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors, Baseline, and post-Baseline Day 1 to Day 7 Itch NRS Score as predicators. | Posted | Number | percentage of participants | Baseline to Day 3 |
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| Secondary | VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event 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 be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. | Safety Population: all randomized participants who applied ruxolitinib 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. | Posted | Count of Participants | Participants | from Baseline up to Week 8 |
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| Secondary | LTS Period: Number of Participants With Any TEAE | An adverse event 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 be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. | LTS Evaluable Population: all participants who applied study drug at least once during the LTS Period | Posted | Count of Participants | Participants | From Week 8 up to Week 56 |
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| Secondary | VC Period: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (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. | Safety Population | Posted | Count of Participants | Participants | from Baseline up to Week 8 |
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| Secondary | LTS Period: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (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. | LTS Evaluable Population | Posted | Count of Participants | Participants | From Week 12 up to Week 56 |
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| Secondary | VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4 | The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Weeks 2 and 4 |
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| Secondary | VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD 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. | ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Weeks 2 and 4 |
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| Secondary | VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (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 ≥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), each 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. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Weeks 2, 4, and 8 |
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| Secondary | VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points | The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses. | ITT Population. Participants who were at least 6 years of age and had a Baseline Itch NRS score ≥2 (for assessment of improvement of at least 2 points) or ≥4 (for assessment of improvement of at least 4 points), a daily Itch NRS assessment during the VC Period, and available data were included in the analysis. | Posted | Median | 95% Confidence Interval | days | up to Week 8 |
|
up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
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 received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 up to Week 8. | 0 | 65 | 0 | 65 | 4 | 65 |
| EG001 | Ruxolitinib 0.75% Cream BID | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 up to Week 8. Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. | 0 | 159 | 0 | 159 | 50 | 159 |
| EG002 | Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 up to Week 8. Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. | 0 | 154 | 3 | 154 | 49 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eczema herpeticum | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | 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 | Jun 2, 2023 | May 8, 2024 | SAP_001.pdf |
Not provided
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Protocol-specified Withdrawal Criterion Met |
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| Non-compliance with Study Drug |
|
| Follow-up Not Performed per Protocol |
|
| Male |
|
| Black/African-American |
|
| Asian |
|
| American-Indian/Alaska Native |
|
| Native Hawaiian/Pacific Islander |
|
| Not Reported |
|
| Black or African American and White |
|
| Mixed, Black |
|
| Captured as Hispanic or Latino in Database |
|
| Caucasian and North African |
|
| Caregiver Did Not Identify |
|
| Puerto Rican |
|
| Black and Asian |
|
| African-American/Black, Hispanic, and Caucasian/White |
|
| Portuguese |
|
| Brazilian |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| Unknown |
|
| Asian |
|
| Exact Logistic Regression |
| <0.0001 |
The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. |
| Odds Ratio (OR) |
| 10.72 |
| 2-Sided |
| 95 |
| 4.429 |
| 30.042 |
| Superiority |
| VC Period: Ruxolitinib 1.5% Cream BID |
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|
|
| OG002 | VC Period: Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|
| OG002 | VC Period: Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|
| OG002 | VC Period: Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|
| OG002 | LTS Period: Ruxolitinib 0.75% Cream BID | Participants who applied ruxolitinib 0.75% cream during the VC Period continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| OG003 | LTS Period: Ruxolitinib 1.5% Cream BID | Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
|
|
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
| OG002 | VC Period: Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|
Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| OG002 | LTS Period: Ruxolitinib 0.75% Cream BID | Participants who applied ruxolitinib 0.75% cream during the VC Period continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| OG003 | LTS Period: Ruxolitinib 1.5% Cream BID | Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
|
|
|
|
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|
| OG002 | VC Period: Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|
| OG002 | VC Period: Ruxolitinib 1.5% Cream BID | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|