A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
NCT ID: NCT06832618
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2025-06-17
2028-05-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle-controlled (VC) Period: Ruxolitinib (1.5% Cream)
Study drug will be administered twice daily.
Ruxolitinib
The study cream will be applied topically as defined in the protocol for each period.
VC Period: Vehicle Cream
Matching vehicle cream will be administered twice daily.
Vehicle Cream
Matching vehicle cream will be applied topically as defined in the protocol for each period.
Disease Control (DC) Period: Ruxolitinib (1.5% Cream)
Study drug will be administered twice weekly.
Ruxolitinib
The study cream will be applied topically as defined in the protocol for each period.
DC Period: Vehicle Cream
Matching vehicle cream will be administered twice weekly.
Vehicle Cream
Matching vehicle cream will be applied topically as defined in the protocol for each period.
DC Period: Open Label - Ruxolitinib (1.5% Cream)
Study drug will be administered twice daily to treat Disease Exacerbations.
Ruxolitinib
The study cream will be applied topically as defined in the protocol for each period.
Open-label Extension (OLE) period: Ruxolitinib (1.5% Cream)
Study drug will be administered twice daily.
Ruxolitinib
The study cream will be applied topically as defined in the protocol for each period.
Interventions
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Ruxolitinib
The study cream will be applied topically as defined in the protocol for each period.
Vehicle Cream
Matching vehicle cream will be applied topically as defined in the protocol for each period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
* AD duration of at least 3 months for 6 to 11 year olds and at least 2 years for 12 to \< 18 year olds (participant/parent/guardian may verbally report signs and symptoms of AD).
* EASI score \> 7 at the screening and VC Day 1 visits.
* IGA score of 3 at the screening and VC Day 1 visits.
* Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20% at the screening and VC Day 1 visits.
* Itch NRS or WI NRS score ≥ 4 at the screening and VC Day 1 visits, defined as the average of the 7 days directly before the VC/Day 1 visit, with Itch NRS or WI NRS values available for at least 4 of the 7 days.
* Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs as follows:
* Inadequate response:
* For TCSs: Inability of a given TCS to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment for 28 days or for the maximum duration recommended by the product prescribing information (eg, 14 days for superpotent TCSs), whichever is shorter and
* For TCIs: Inability of a given TCI to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment according to the product prescribing information.
Note: Documented (within 12 months before the screening visit) systemic treatment for AD (eg, oral corticosteroids, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil) or phototherapy or photo(chemo)therapy can also be considered as a surrogate for inadequate response to TCSs and TCIs.
• Intolerance: Clinically relevant side effects, safety risks, or skin tolerability issues that outweigh the potential treatment benefits and are the reason why a topical treatment could not be restarted or continued.
Note: Documented history (more than 12 months prior to the screening visit) of clinically significant adverse reactions with use of TCSs and/or TCIs that in the opinion of the investigator outweigh the benefits of restarting treatment would also be considered as evidence of intolerance.
• Contraindication: As defined in the product prescribing information.
* Agreement by participants and guardians to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit, except as outlined in the protocol.
* For sexually active participants, willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of prepubescent participants.
Note: Female participants who have reached menarche must have a negative urine pregnancy test at the screening and baseline visits before the first application of study cream at baseline. They must also take appropriate precautions to avoid pregnancy from the screening visit through the safety follow-up visit.
\- Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible.
Note: A signed written ICF must be obtained for inclusion; see protocol.
Exclusion Criteria
* Concurrent conditions and history of other diseases as follows:
* Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
* Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the VC Day 1 visit.
* Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before the VC Day 1 visit.
* Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
* Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.
* Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream.
* Current or history of hepatitis B or C virus infection.
* 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:
* Absolute neutrophil count \< 1000/μL.
* Platelet count \< 100,000/μL.
* AST or ALT ≥ 2 × ULN.
* Alkaline phosphatase \> 1.5 × ULN.
* Bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin isfractionated and direct bilirubin \< 35%) with the exception of Gilbert disease.
* Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease 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 the VC Day 1 visit:
* 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor.
* 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating (eg, mycophenolate or tacrolimus) agents.
* 2 weeks or 5 half-lives, whichever is longer: strong systemic CYP3A4 inhibitors.
* 2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted).
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.
* History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or any other inflammatory condition.
* 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 that is thought by the investigator to potentially impact the participant's AD.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug Protocol.
* Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
* Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
* Known allergy or reaction to any component of the study cream formulation.
* In the opinion of the investigator, unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance).
* Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
* Employees of the sponsor, sponsor delegates (eg, contract research organizations), or investigators or are otherwise dependents of them.
* The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
* In the EU, participants considered incapacitated (according to CTR Article 31).
6 Years
17 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Saguaro Dermatology
Phoenix, Arizona, United States
National Jewish Health
Denver, Colorado, United States
Encore Medical Research, Llc Hollywood
Hollywood, Florida, United States
Cleaver Medical Group
Cumming, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Sneeze Wheeze and Itch Associates Llc
Normal, Illinois, United States
Endeavor Health Medical Group
Skokie, Illinois, United States
Raven Clinical Research
Marriottsville, Maryland, United States
Oakland Hills Dermatology Pc
Auburn Hills, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Red River Research Partners
Bolivar, Missouri, United States
Medisearch Clinical Trials
Saint Joseph, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Lane Dermatology and Dermatologic Surgery
Columbus, Ohio, United States
University of Texas Physicians - Bellaire Station
Bellaire, Texas, United States
Frontier Dermatology
Mill Creek, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cliniques Universitaires Ucl Saint-Luc
Brussels, , Belgium
Az Sint-Lucas
Ghent, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Grand Hôpital de Charleroi-Les Viviers
Gilly, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Dermatologie Maldegem
Maldegem, , Belgium
Dermatology Research Institute Inc.
Calgary, Alberta, Canada
Laster Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, Canada
Dr. Chih-Ho Hong Medical Inc.
Surrey, British Columbia, Canada
University of British Columbia (Ubc) - British Columbia Children'S Hospital (Bc Children'S Hospital)
Vancouver, British Columbia, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
Leader Research
Hamilton, Ontario, Canada
K. Papp Clinical Research
Ontario, Ontario, Canada
Skin Centre For Dermatology
Peterborough, Ontario, Canada
Facet Dermatology
Toronto, Ontario, Canada
Centre de Recherche Saint-Louis
Montreal, Quebec, Canada
Chu Sainte-Justine
Montreal, Quebec, Canada
Chu de Quebec Universite Laval
Québec, Quebec, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
Skincare Studio Dermatology Centre
St. John's, , Canada
Bordeaux Chu Hopital Saint - Andre
Bordeaux, , France
Polyclinique Reims-Bezannes
Reims, , France
Hopitaux Drome Nord
Romans-sur-Isère, , France
Fachklinik Bad Bentheim Dermatologie
Bad Bentheim, , Germany
St. Josef-Hospital Universitaetsklinikum
Bochum, , Germany
Universitatsklinikum Bonn Aoer
Bonn, , Germany
Drk Krankenhaus Chemnitz-Rabenstein
Chemnitz, , Germany
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Universitatsmedizin Goettingen
Göttingen, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Universitatsklinikum Munster
Münster, , Germany
Clinexpert Kft.
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, , Hungary
Geomedical Orvosi Kft.
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
Debrecen, , Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, , Hungary
Pecsi Tudomanyegyetem
Pécs, , Hungary
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
Catania, , Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, , Italy
Azienda Ospedaliera Universitaria Federico Ii
Naples, , Italy
Azienda Ospedale Universita Di Padova
Padua, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, , Italy
Umc Utrecht
Utrecht, , Netherlands
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
Gdansk, , Poland
Gyncentrum Sp. Z O.O.
Katowice, , Poland
Centrum Medyczne All-Med Badania Kliniczne
Krakow, , Poland
Diamond Clinic Sp. Z O.O.
Krakow, , Poland
Dermoklinika
Lodz, , Poland
Clinical Best Solutions Sp. Z O.O. Sp. K.
Lublin, , Poland
Dermodent Centrum Medyczne Czajkowscy S.C.
Osielsko, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
Mics Centrum Medyczne Toruń
Torun, , Poland
Mics Centrum Medyczne Warszawa Chlodna
Warsaw, , Poland
High-Med Przychodnia Specjalistycza
Warsaw, , Poland
Centrum Medyczne Evimed
Warsaw, , Poland
Etg Warszawa
Warsaw, , Poland
Dermmedica Sp. Z O.O.
Wroclaw, , Poland
Hospital General Unviersitario de Alicante
Alicante, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario de La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, , Spain
Hospital de Manis
Manises, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
West Glasgow Ambulatory Care Hospital
Glasgow, , United Kingdom
St John'S Institute of Dermatology
London, , United Kingdom
The Adam Practice
Metropolitan Borough of Wirral, , United Kingdom
University of Nottingham Health Service
Nottingham, , United Kingdom
Sheffield Childrens Hospital
Sheffield, , United Kingdom
Walsall Manor Hospital
Walsall, , United Kingdom
Countries
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Central Contacts
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Related Links
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A study to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis
Other Identifiers
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2024-518156-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB018424-316
Identifier Type: -
Identifier Source: org_study_id