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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505433-27-00 | Registry Identifier | EU CT Number |
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This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VC Period: Ruxolitinib 1.5% Cream BID | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
| VC Period: Vehicle Cream BID | Placebo Comparator | Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
| VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BID | Experimental | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 24 during the Vehicle Control Extension (VCE) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
|
| VC Extension Period/Escape Arm: Vehicle Cream BID | Placebo Comparator | Participants who applied vehicle cream during the VC Period, continued applying vehicle cream as a thin film twice daily (BID) from Weeks 8 to 24 during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants will be eligible to enter the ruxolitinib 1.5% cream open-label escape arm as defined in the protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib Cream | Drug | Ruxolitinib cream applied topically to the affected area as a thin film twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) at Week 8 | EASI75 was defined as achieving a ≥75% improvement in the EASI score compared to the baseline score. The EASI scoring system is a validated scoring system that grades the physical signs of atopic dermatitis (AD) to provide a measure of AD severity (ranging from 0 to 72). The disease severity strata for the EASI are: 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. | Baseline; Week 8 |
| Percentage of Participants With Investigator's Global Assessment Treatment Success (IGA-TS) at Week 8 | IGA-TS was defined as achieving an IGA score of 0 or 1 with a ≥2-grade improvement from baseline. The IGA is an overall eczema severity rating on a 0 to 4 scale. 0: clear; no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1: almost clear; may be trace faint pink erythema, with almost no induration/papulation, and no oozing/crusting. 2: mild; may be faint pink erythema, with mild induration/papulation and no oozing/crusting. 3: moderate; may be pink-red erythema with moderate induration/papulation and may be some oozing/crusting. 4: severe; may be deep or bright red erythema with severe induration/papulation and with oozing/crusting. | Baseline; Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a ≥4-point Improvement in Itch Numeric Rating Scale (NRS) Score (ITCH4) From Baseline to Week 8 | Baseline; Week 8 | |
| Percentage of Participants Achieving ITCH4 From Baseline to Days 2, 3, and 7 | Baseline; Days 2, 3, and 7 |
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Inclusion Criteria:
Exclusion Criteria:
Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
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 cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Any of the following clinical laboratory test results at screening:
Hemoglobin < 10 g/dL.
Liver function tests:
Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation).
Positive serology test results for HIV antibody.
Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
Use of any of the following treatments within the indicated washout period before Day 1:
Note: COVID-19 vaccination is allowed.
• 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.
Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72204 | United States | ||
| First Oc Dermatology |
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| Label | URL |
|---|---|
| A study to evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis | View source |
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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 study was conducted at 75 study centers in Europe, North America, and Australia. Participants could have entered the open-label Escape Arm either at Week 8 (end of the VC Period) or anytime during the VCE DB Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Cream | During the 8-week vehicle-controlled (VC) period, participants applied vehicle cream twice daily (BID) to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the Eczema Area and Severity Index (EASI) score from baseline (EASI50), continued blinded treatment with vehicle cream BID and were evaluated for durability of response during an additional 16-week period vehicle-controlled extension double-blind period (VCE DB). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded-Treatment 8-Week VC Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2024 | Apr 9, 2026 |
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|
| VC Extension Period: Ruxolitinib 1.5% cream open-label escape arm | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
|
|
| Vehicle Cream | Drug | Matching vehicle cream applied topically to the affected area as a thin film twice daily. |
|
| Vehicle-controlled (VC) Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) | up to Week 12 |
| Vehicle-controlled Extension Double-blind (VCE DB) Period: Number of Participants With Any TEAE | up to 16 weeks (from Week 8 to Week 24) |
| VCE Escape Arm: Number of Participants With Any TEAE | up to 150 days |
| VC Period: Number of Participants With Any ≥Grade 3 TEAE | up to Week 12 |
| VCE DB Period: Number of Participants With Any ≥Grade 3 TEAE | up to 16 weeks (from Week 8 to Week 24) |
| VCE Escape Arm: Number of Participants With Any ≥Grade 3 TEAE | up to 150 days |
| Double-blind Treatment Period: Percentage of Participants Achieving EASI75 From Baseline at Weeks 2, 4, 12, 16, 20, and 24 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 |
| VCE Escape Arm: Percentage of Participants Achieving EASI75 From Baseline at Weeks 12, 16, 20, and 24 | Baseline; Weeks 12, 16, 20, and 24 |
| Double-blind Treatment Period: Percentage of Participants With IGA-TS From Baseline at Each Postbaseline Visit Except Week 8 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 |
| VCE Escape Arm: Percentage of Participants With IGA-TS From Baseline at Weeks 12, 16, 20, and 24 | Baseline; Weeks 12, 16, 20, and 24 |
| Percentage of Participants Achieving ITCH4 From Baseline to Weeks 2 and 4 | Baseline; Weeks 2 and 4 |
| Time to Achieve ITCH4 During the VC Period | up to Week 8 |
| Time to Achieve ITCH2 During the VC Period | up to Week 8 |
| Change From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-initial Dose on Day 1 | Baseline; Day 1 |
| Percentage of Participants Achieving at Least a 2-point Decrease From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-Initial Dose on Day 1 | Baseline; Day 1 |
| Percentage of Participants Achieving at Least a 4-point Decrease From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-Initial Dose on Day 1 | Baseline; Day 1 |
| Double-blind Treatment Period: Percentage of Participants Achieving EASI50 From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 |
| Double-blind Treatment Period: Percentage of Participants With EASI90 From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 |
| Double-blind Treatment Period: Percentage of Participants Achieving Both EASI75 and IGA-TS at Weeks 2, 4, 8, 12, 16, 20, and 24 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 |
| Change From Baseline for Atopic Dermatitis-affected %Body Surface Area (BSA) at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline for Atopic Dermatitis-affected %BSA at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline for the EASI Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline for the EASI Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline for the SCORing Atopic Dermatitis (SCORAD) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline for the SCORAD Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline for Itch NRS Score at Days 1 Through 56 (8 Weeks) | Baseline; Days 1 through 56 (8 weeks) |
| Change From Baseline for Skin Pain NRS Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline for Skin Pain NRS Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Baseline; Weeks 12, 16, 20, and 24 |
| Time to Open-label Escape Arm | up to 16 weeks (from Week 8 to Week 24) |
| Percentage of Participants in the VCE DB Period Concurrently Meeting All of the Following Criteria: IGA Score ≥3, EASI Score ≥16, Itch NRS Score, ≥4, BSA ≥10%, and Dermatology Life Quality Index (DLQI) Score >10 | up to 16 weeks (from Week 8 to Week 24) |
| Time to Participants in the VCE DB Period Concurrently Meeting All of the Following Criteria: IGA Score ≥3, EASI Score ≥16, Itch NRS Score ≥4, BSA ≥10%, and DLQI Score >10 | up to 16 weeks (from Week 8 to Week 24) |
| Percentage of Participants Who Experienced a Relapse After Study Treatment Discontinuation | up to 30 days following Week 24 |
| Time to First Retreatment During the VCE DB Period | up to 16 weeks (from Week 8 to Week 24) |
| Percentage of Time Off Study Treatment Due to Lesion Clearance During the VCE DB Period | from Week 8 to Week 24 |
| Percentage of Time on Study Treatment During the VCE DB Period | from Week 8 to Week 24 |
| Double-blind Treatment Period: Percentage of Participants Who Achieved a ≥4-point Improvement in Dermatology Life Quality Index (DLQI) From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 |
| Change From Baseline in the DLQI Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline in the DLQI Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline in the Patient-oriented Eczema Measure (POEM) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline in the POEM Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline in the EQ-5D-5L Visual Analog Scale Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline in the EQ-5D-5L Visual Analog Scale Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline in the HADS Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep-Related Impairment (8a: 7-day Recall) Score at Weeks 2, 4, and 8 | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline in the PROMIS Short Form - Sleep-Related Impairment (8a: 7-day Recall) Score at Weeks 12, 16, 20, and 24 | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline in the PROMIS Short Form - Sleep Disturbance (8b: 7-day Recall) Score at Weeks 2, 4, and 8 | Baseline; Weeks 2, 4, and 8 |
| Change From Baseline in the PROMIS Short Form - Sleep Disturbance (8b: 7-day Recall) Score at Weeks 12, 16, 20, and 24 | Baseline; Weeks 12, 16, 20, and 24 |
| Change From Baseline in the Work Productivity and Activity Impairment Questionairre-Atopic Dermatitis (WPAI-AD) Score at Weeks 8 and 24 | Baseline; Weeks 8 and 24 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Center For Dermatology Cosmetic and Laser Surgery | Fremont | California | 94538 | United States |
| Medderm Associates, Inc | San Diego | California | 92103 | United States |
| Encore Medical Research, Llc Hollywood | Hollywood | Florida | 33021 | United States |
| Entrust Clinical Research | Miami | Florida | 33176 | United States |
| Lane Dermatology and Dermatologic Surgery | Columbus | Georgia | 31904 | United States |
| Marietta Dermatology the Skin Cancer Center Marietta | Marietta | Georgia | 30060 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | United States |
| Northshore University Healthsystem | Skokie | Illinois | 60077 | United States |
| Oakland Hills Dermatology Pc | Auburn Hills | Michigan | 48326 | United States |
| Revival Research Institute, Llc Troy | Troy | Michigan | 48084 | United States |
| Best Skin Research | Camp Hill | Pennsylvania | 17011 | United States |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | 37130 | United States |
| Center For Clinical Studies Webster | Houston | Texas | 77004 | United States |
| Texas Dermatology Research Center | Plano | Texas | 75025 | United States |
| Rainey and Finklea Dermatology | San Antonio | Texas | 78213 | United States |
| North Sound Dermatology | Mill Creek | Washington | 98012 | United States |
| Premier Specialists Pty Ltd | Kogarah | New South Wales | 02217 | Australia |
| Australian Clinical Research Network | Maroubra | New South Wales | 02035 | Australia |
| Veracity Clinical Research | Woolloongabba | Queensland | 04102 | Australia |
| Clinical Trials Sa | Campbelltown | South Australia | 05074 | Australia |
| Skin Health Institute Inc. | Carlton | Victoria | 03053 | Australia |
| Paratus Clinical Research, Woden | Phillip | 02606 | Australia |
| Ulb Hospital Erasme | Brussels | 01070 | Belgium |
| Cliniques Universitaires Ucl Saint-Luc | Brussels | 01200 | Belgium |
| Universitair Ziekenhuis Antwerpen (Uza) | Edegem | 02650 | Belgium |
| Universitair Ziekenhuis Gent (Uz Gent) | Ghent | 09000 | Belgium |
| Grand Hopital de Charleroi | Gilly | 06060 | Belgium |
| Dermatologie Handelskaai | Kortrijk | 08500 | Belgium |
| Mhat Dr. Tota Venkova Ad | Gabrovo | 05300 | Bulgaria |
| Medical Center Medconsult Pleven Ood | Pleven | 05800 | Bulgaria |
| Ambulatory For Specialized Medical Help - Skin and Venereal Diseases | Sofia | 01407 | Bulgaria |
| Dcc 'Alexandrovska', Eood | Sofia | 01431 | Bulgaria |
| Medical Center Hera Eood | Sofia | 01510 | Bulgaria |
| Diagnostic Consultative Center Xxviii | Sofia | 01592 | Bulgaria |
| Medical Center Assoc. Prof. Vasilev | Sofia | 01618 | Bulgaria |
| Dermatology Research Institute Inc. | Calgary | Alberta | T2J 7E1 | Canada |
| Dr. Chih-Ho Hong Medical Inc. | Surrey | British Columbia | V3R 6A7 | Canada |
| Wiseman Dermatology Research Inc | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Dr. Irina Turchin Pc Inc. | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X3 | Canada |
| Skin Centre For Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| Centre de Recherche Dermatologique Du Quebec Metropolitain | Québec | Quebec | G1V 4X7 | Canada |
| Skincare Studio Dermatology Centre | St. John's | A1E 1V4 | Canada |
| Ghicl - Hôpital Saint-Vincent de Paul | Lille | 59020 | France |
| Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu | Nantes | 44093 | France |
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Chu de Rouen - Hospital Charles Nicolle | Rouen | 76000 | France |
| University Hospital of Saint Etienne | Saint-Etienne | 42055 | France |
| Universitaetsklinikum Augsburg Sued | Augsburg | 86179 | Germany |
| Fachklinik Bad Bentheim Dermatologie | Bad Bentheim | 48455 | Germany |
| Praxis Fuer Haut- Und Geschlechtskrankheiten Dr. Med. Thomas Wildfeuer Und Partner | Berlin | 13055 | Germany |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| Dermatologie Potsdam Mvz Gmbh | Potsdam | 14467 | Germany |
| Clinexpert Kft. | Budapest | 01033 | Hungary |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 01036 | Hungary |
| Semmelweis Egyetem | Budapest | 01085 | Hungary |
| Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika | Debrecen | 04032 | Hungary |
| Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | 06720 | Hungary |
| Fondazione Irccs Ca Granda Ospedale Maggiore | Milan | 20122 | Italy |
| Azienda Ospedaliera Universitaria Federico Ii | Naples | 80131 | Italy |
| Universita Degli Studi Della Campania Luigi Vanvitelli | Naples | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs | Rome | 00168 | Italy |
| Irccs Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Bravis Ziekenhuis | Bergen op Zoom | 4624 VT | Netherlands |
| Amphia Ziekenhuis, Molengracht | Breda | 04818 | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713GZ | Netherlands |
| Centrum Badan Klinicznych Pi-House Sp. Z O.O. | Gdansk | 80-546 | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | 40-081 | Poland |
| Centrum Medyczne All-Med | Krakow | 30-033 | Poland |
| Pratia McM Krakow | Krakow | 30-727 | Poland |
| Santa Sp. Z O.O. Santa Familia Ptg Lodz | Lodz | 90-302 | Poland |
| Etg Lublin | Lublin | 20-412 | Poland |
| Solumed Centrum Medyczne | Poznan | 60-529 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71- 500 | Poland |
| Centrum Medyczne Evimed | Warsaw | 02-625 | Poland |
| Klinika Ambroziak Dermatologia | Warsaw | 02-953 | Poland |
| Dermmedica Sp. Z O.O. | Wroclaw | 51-503 | Poland |
| Ceim Hospital Universitari Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital de La Santa Creu I Sant Pau | Barcelona | 08041 | Spain |
| Hospital Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Universitario de La Paz | Madrid | 28046 | Spain |
| Hospital de Manises | Manises | 46940 | Spain |
| Hospital Marina Baixa | Villajoyosa | 03570 | Spain |
| Universitatsspital Basel | Basel | CH-4055 | Switzerland |
| Inselspital Universitatsklinik Fur Medizinische Onkologie | Bern | 03010 | Switzerland |
| Dermatology & Skin Care Clinic | Buochs | 06374 | Switzerland |
| Universitatsspital Zurich | Zurich | 08091 | Switzerland |
| West Middlesex University Hospital | Isleworth | TW7 6AF | United Kingdom |
| Guys Hospital | London | SE1 9RT | United Kingdom |
| Northampton General Hospital | Northampton | NN1 5BD | United Kingdom |
| University Hospital Plymouth | Plymouth | PL6 8DH | United Kingdom |
| Walsall Manor Hospital | Walsall | WS2 9PS | United Kingdom |
| FG001 | Ruxolitinib 1.5% Cream | During the 8-week VC period, participants applied ruxolitinib 1.5% cream BID to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the EASI score from baseline (EASI50), continued blinded treatment with ruxolitinib 1.5% cream BID and were evaluated for durability of response during an additional 16-week period VCE DB period. |
| FG002 | Vehicle Cream to Ruxolitinib 1.5% Cream | Participants who were randomized to receive vehicle cream BID at the beginning of the VC period and did not have an adequate response at Week 8 or had lost EASI50 response (i.e., \ |
| FG003 | Ruxolitinib 1.5% Cream to Ruxolitinib 1.5% Cream | Participants who were randomized to receive ruxolitinib 1.5% cream BID at the beginning of the VC period and did not have an adequate response at Week 8 or had lost EASI50 response (i.e., \ |
| Entered Escape Arm at Week 8 |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Blinded-Treatment 16-Week VCE DB Period |
|
|
| Open-Label Escape 16-Week VCE DB Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Cream | Participants applied vehicle cream twice daily (BID) for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% body surface area (BSA). |
| BG001 | Ruxolitinib 1.5% Cream | Participants applied ruxolitinib 1.5% cream BID for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% BSA. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 Achieving a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) at Week 8 | EASI75 was defined as achieving a ≥75% improvement in the EASI score compared to the baseline score. The EASI scoring system is a validated scoring system that grades the physical signs of atopic dermatitis (AD) to provide a measure of AD severity (ranging from 0 to 72). The disease severity strata for the EASI are: 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. | Intent-to-Treat (ITT) Population: all participants who were randomized to the study. Treatment groups were defined according to the treatment assignment at the time of randomization, regardless of the actual study treatment applied. The confidence interval was calculated based on exact methods for binomial distribution. Nonresponder imputation: missing postbaseline values were imputed as nonresponders at Week 8. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Week 8 |
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| Primary | Percentage of Participants With Investigator's Global Assessment Treatment Success (IGA-TS) at Week 8 | IGA-TS was defined as achieving an IGA score of 0 or 1 with a ≥2-grade improvement from baseline. The IGA is an overall eczema severity rating on a 0 to 4 scale. 0: clear; no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1: almost clear; may be trace faint pink erythema, with almost no induration/papulation, and no oozing/crusting. 2: mild; may be faint pink erythema, with mild induration/papulation and no oozing/crusting. 3: moderate; may be pink-red erythema with moderate induration/papulation and may be some oozing/crusting. 4: severe; may be deep or bright red erythema with severe induration/papulation and with oozing/crusting. | ITT Population. The confidence interval was calculated based on exact methods for binomial distribution. Nonresponder imputation: missing postbaseline values were imputed as nonresponders at Week 8. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Week 8 |
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| Secondary | Percentage of Participants Achieving a ≥4-point Improvement in Itch Numeric Rating Scale (NRS) Score (ITCH4) From Baseline to Week 8 | Not Posted | Oct 2026 | Baseline; Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ITCH4 From Baseline to Days 2, 3, and 7 | Not Posted | Oct 2026 | Baseline; Days 2, 3, and 7 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Vehicle-controlled (VC) Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) | Not Posted | Oct 2026 | up to Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Vehicle-controlled Extension Double-blind (VCE DB) Period: Number of Participants With Any TEAE | Not Posted | Oct 2026 | up to 16 weeks (from Week 8 to Week 24) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VCE Escape Arm: Number of Participants With Any TEAE | Not Posted | Oct 2026 | up to 150 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VC Period: Number of Participants With Any ≥Grade 3 TEAE | Not Posted | Oct 2026 | up to Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VCE DB Period: Number of Participants With Any ≥Grade 3 TEAE | Not Posted | Oct 2026 | up to 16 weeks (from Week 8 to Week 24) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VCE Escape Arm: Number of Participants With Any ≥Grade 3 TEAE | Not Posted | Oct 2026 | up to 150 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Treatment Period: Percentage of Participants Achieving EASI75 From Baseline at Weeks 2, 4, 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VCE Escape Arm: Percentage of Participants Achieving EASI75 From Baseline at Weeks 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Treatment Period: Percentage of Participants With IGA-TS From Baseline at Each Postbaseline Visit Except Week 8 | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VCE Escape Arm: Percentage of Participants With IGA-TS From Baseline at Weeks 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ITCH4 From Baseline to Weeks 2 and 4 | Not Posted | Oct 2026 | Baseline; Weeks 2 and 4 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Achieve ITCH4 During the VC Period | Not Posted | Oct 2026 | up to Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Achieve ITCH2 During the VC Period | Not Posted | Oct 2026 | up to Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-initial Dose on Day 1 | Not Posted | Oct 2026 | Baseline; Day 1 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving at Least a 2-point Decrease From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-Initial Dose on Day 1 | Not Posted | Oct 2026 | Baseline; Day 1 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving at Least a 4-point Decrease From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-Initial Dose on Day 1 | Not Posted | Oct 2026 | Baseline; Day 1 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Treatment Period: Percentage of Participants Achieving EASI50 From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Treatment Period: Percentage of Participants With EASI90 From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Treatment Period: Percentage of Participants Achieving Both EASI75 and IGA-TS at Weeks 2, 4, 8, 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Atopic Dermatitis-affected %Body Surface Area (BSA) at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Atopic Dermatitis-affected %BSA at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for the EASI Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for the EASI Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for the SCORing Atopic Dermatitis (SCORAD) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for the SCORAD Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Itch NRS Score at Days 1 Through 56 (8 Weeks) | Not Posted | Oct 2026 | Baseline; Days 1 through 56 (8 weeks) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Skin Pain NRS Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Skin Pain NRS Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Open-label Escape Arm | Not Posted | Oct 2026 | up to 16 weeks (from Week 8 to Week 24) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in the VCE DB Period Concurrently Meeting All of the Following Criteria: IGA Score ≥3, EASI Score ≥16, Itch NRS Score, ≥4, BSA ≥10%, and Dermatology Life Quality Index (DLQI) Score >10 | Not Posted | Oct 2026 | up to 16 weeks (from Week 8 to Week 24) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Participants in the VCE DB Period Concurrently Meeting All of the Following Criteria: IGA Score ≥3, EASI Score ≥16, Itch NRS Score ≥4, BSA ≥10%, and DLQI Score >10 | Not Posted | Oct 2026 | up to 16 weeks (from Week 8 to Week 24) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced a Relapse After Study Treatment Discontinuation | Not Posted | Oct 2026 | up to 30 days following Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Retreatment During the VCE DB Period | Not Posted | Oct 2026 | up to 16 weeks (from Week 8 to Week 24) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Time Off Study Treatment Due to Lesion Clearance During the VCE DB Period | Not Posted | Oct 2026 | from Week 8 to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Time on Study Treatment During the VCE DB Period | Not Posted | Oct 2026 | from Week 8 to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Treatment Period: Percentage of Participants Who Achieved a ≥4-point Improvement in Dermatology Life Quality Index (DLQI) From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the DLQI Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the DLQI Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Patient-oriented Eczema Measure (POEM) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the POEM Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EQ-5D-5L Visual Analog Scale Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EQ-5D-5L Visual Analog Scale Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the HADS Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep-Related Impairment (8a: 7-day Recall) Score at Weeks 2, 4, and 8 | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the PROMIS Short Form - Sleep-Related Impairment (8a: 7-day Recall) Score at Weeks 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the PROMIS Short Form - Sleep Disturbance (8b: 7-day Recall) Score at Weeks 2, 4, and 8 | Not Posted | Oct 2026 | Baseline; Weeks 2, 4, and 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the PROMIS Short Form - Sleep Disturbance (8b: 7-day Recall) Score at Weeks 12, 16, 20, and 24 | Not Posted | Oct 2026 | Baseline; Weeks 12, 16, 20, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Work Productivity and Activity Impairment Questionairre-Atopic Dermatitis (WPAI-AD) Score at Weeks 8 and 24 | Not Posted | Oct 2026 | Baseline; Weeks 8 and 24 | Participants |
up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
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 | During the 8-week vehicle-controlled (VC) period, participants applied vehicle cream twice daily (BID) to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the Eczema Area and Severity Index (EASI) score from baseline (EASI50), continued blinded treatment with vehicle cream BID and were evaluated for durability of response during an additional 16-week period vehicle-controlled extension double-blind period (VCE DB). | 1 | 81 | 1 | 81 | 12 | 81 |
| EG001 | Ruxolitinib 1.5% Cream | During the 8-week VC period, participants applied ruxolitinib 1.5% cream BID to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the EASI score from baseline (EASI50), continued blinded treatment with ruxolitinib 1.5% cream BID and were evaluated for durability of response during an additional 16-week period VCE DB period. | 0 | 204 | 4 | 204 | 33 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
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 | May 6, 2025 | Apr 9, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| D004485 | Eczema |
| 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 |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Withdrawal by Subject |
|
| Pregnancy |
|
| Ongoing |
|
| Entered the Escape Arm |
|
| Withdrawal by Subject |
|
| Sponsor Decision |
|
| Ongoing |
|
| Male |
|
| Black/African-American |
|
| Asian |
|
| Native Hawaiian/Pacific Islander |
|
| Not Reported |
|
| Phillipino |
|
| Mix of White and American-Indian |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| Unknown |
|
| Missing |
|
Participants applied ruxolitinib 1.5% cream BID for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% BSA.
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