Clinical trial NCT06832618: A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
Official title: A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Ruxolitinib
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Aged 6 to \< 18 years at the VC Day 1 visit.
* 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:

* Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to the VC Day 1 visit.
* 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).

Primary outcomes:
measure: VC Period: Binary response status of Eczema Area and Severity Index 75 (EASI75)
timeFrame: VC Week 8
Secondary outcomes:
measure: VC Period: Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS)
timeFrame: VC Week 8
measure: VC Period: Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
timeFrame: VC Week 8
measure: DC Period: Time to first disease exacerbation, defined as Investigator's Global Assessment score of ≥ 2 (DE) in the DC period
timeFrame: Up to 44 Weeks
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Baseline up to 70 weeks
measure: Binary response status of Eczema Area and Severity Index 75 (EASI75) at each postbaseline visit except Week 8
timeFrame: Up to 44 weeks
measure: Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS) at each postbaeline visit except Week 8
timeFrame: Up to 44 weeks
measure: Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
timeFrame: Days 2, 3, and 7 and VC Weeks 2 and 4
measure: VC Period: Time to achieve ITCH4
timeFrame: Up to 8 weeks
measure: VC Period: Binary response status of both EASI75 and IGA-TS at each postbaseline visit in the VC period
timeFrame: Up to 44 weeks
measure: VC Period: The binary response status of DLQI-4/CDLQI-4 at VC Weeks 2, 4, and 8
timeFrame: Weeks 2, 4 and 8
measure: VC Period and DC Period: Change from baseline in the CDLQI (or DLQI) score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: VC Period and DC Period: Change from baseline in the Patient-Oriented Eczema Measure (POEM) score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: VC Period and DC Period: Acceptability and tolerability assessment (exit interview/questionnaire)
timeFrame: VC Period Week 8 and DC Period Week 44
measure: DC Period: Number of disease exacerbations (DEs)
timeFrame: Up to 44 weeks
measure: DC Period: Amount of ruxolitinib cream used
timeFrame: Up to 44 weeks
measure: VC Period: Plasma concentrations of ruxolitinib and PK parameters (Ctrough,ss)
timeFrame: VC Week 2 and VC Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Saguaro Dermatology
state: Arizona
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Cumming
country: United States
facility: Cleaver Medical Group
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Normal
country: United States
facility: Sneeze Wheeze and Itch Associates Llc
state: Illinois
city: Marriottsville
country: United States
facility: Raven Clinical Research
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Bellaire
country: United States
facility: University of Texas Physicians - Bellaire Station
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Brussels
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Gent
country: Belgium
facility: Az Sint-Lucas
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Gilly
country: Belgium
facility: Les Viviers
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Maldegem
country: Belgium
facility: Dermatologie Maldegem
city: Dupnitsa
country: Bulgaria
facility: Medical Centre 'Asklepii', Ood
city: Gabrovo
country: Bulgaria
facility: Mhat Dr. Tota Venkova Ad
city: Sofia
country: Bulgaria
facility: Dcc 'Alexandrovska', Eood
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Xxviii
city: Sofia
country: Bulgaria
facility: Medical Center Assoc. Prof. Vasilev
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc.
state: Alberta
city: Edmonton
country: Canada
facility: Laster Rejuvenation Clinics Edmonton D.T. Inc.
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia (Ubc) - British Columbia Children'S Hospital (Bc Children'S Hospital)
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Hamilton
country: Canada
facility: Leader Research
state: Ontario
city: Toronto
country: Canada
facility: Facet Dermatology
state: Ontario
city: Montréal
country: Canada
facility: Chu Sainte-Justine
state: Quebec
city: Saskatoon
country: Canada
facility: Skinsense Medical Research
state: Saskatchewan
city: Ontario
country: Canada
facility: K. Papp Clinical Research
city: Quebec
country: Canada
facility: Chu de Québec-Université Laval
city: St. John's
country: Canada
facility: Skincare Studio Dermatology Centre
city: Bordeaux
country: France
facility: Bordeaux Chu Hopital Saint - Andre
city: Reims
country: France
facility: Polyclinique Reims-Bezannes
city: Romans-sur-isère
country: France
facility: Hopitaux Drome Nord
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim Dermatologie
city: Bochum
country: Germany
facility: Rhur Universitat Bochum
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn Aoer
city: Chemnitz
country: Germany
facility: Drk Krankenhaus Chemnitz-Rabenstein
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Tu Dresden
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Goettingen
country: Germany
facility: Universitatsmedizin Goettingen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Muenster
country: Germany
facility: Universitatsklinikum Munster
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Geomedical Orvosi Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Varmegyei Oktatokorhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
city: Milano
country: Italy
facility: Fondazione Irccs Ca Granda Ospedale Maggiore
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico Ii
city: Padova
country: Italy
facility: Azienda Ospedale-Università Di Padova
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs
city: Utrecht
country: Netherlands
facility: Umc Utrecht
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych Pi-House Sp. Z O.O.
city: Katowice
country: Poland
facility: Gyncentrum Sp Z O O
city: Krakow
country: Poland
facility: Centrum Medyczne All Med Badania Kliniczne
city: Krakow
country: Poland
facility: Diamond Clinic Specjalistyczne Poradnie Lekarskie
city: Lodz
country: Poland
facility: Dermoklinika
city: Lublin
country: Poland
facility: Clinical Best Solutions
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Torun
country: Poland
facility: Mics Centrum Medyczne Torun
city: Warsaw
country: Poland
facility: Etg Warszawa
city: Warszawa
country: Poland
facility: Mics Centrum Medyczne Warszawa
city: Warszawa
country: Poland
facility: High-Med Przychodnia Specjalistycza
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
city: Wrocław
country: Poland
facility: Dermmedica Sp. Z O.O.
city: Alicante
country: Spain
facility: Hospital General Unviersitario de Alicante
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Manises
country: Spain
facility: Hospital de Manises
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Glasgow
country: United Kingdom
facility: West Glasgow Ambulatory Care Hospital
city: London
country: United Kingdom
facility: St John'S Institute of Dermatology
city: Nottingham
country: United Kingdom
facility: University of Nottingham Health Service
city: Sheffield
country: United Kingdom
facility: Sheffield Childrens Hospital
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
city: Wirral
country: United Kingdom
facility: The Adam Practice
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: