RECRUITING

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-05-28

Study Completion:2028-05-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06832618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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. * 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.	* 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). * 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).

Inclusion Criteria

Exclusion 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.
* 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.

* 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).
* 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).

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423

eumedinfo@incyte.com

Principal Investigator

Incyte Medical Monitor

STUDY_DIRECTOR

Incyte Corporation

Study Locations (Sites)

Clinical Research Center of Alabama

Birmingham, Alabama, 35209

United States

Saguaro Dermatology

Phoenix, Arizona, 85008

United States

National Jewish Health

Denver, Colorado, 80206

United States

Cleaver Medical Group

Cumming, Georgia, 30040

United States

Treasure Valley Medical Research

Boise, Idaho, 83706

United States

Sneeze Wheeze and Itch Associates Llc

Normal, Illinois, 61761

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229

United States

University of Texas Physicians - Bellaire Station

Bellaire, Texas, 77401

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Incyte Corporation

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-28

Study Completion Date2028-05-18

Study Record Updates

Study Start Date2025-05-28

Study Completion Date2028-05-18

Terms related to this study

Keywords Provided by Researchers

Atopic Dermatitis
Ruxolitinib

Additional Relevant MeSH Terms

Atopic Dermatitis