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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT06832618

Run by

Incyte Corporation

People needed

159

Starts

2025-06-17

Expected to finish

2028-05-18

Last updated by the study team

2026-06-16

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Saguaro Dermatology — Phoenix, Arizona, United States
• National Jewish Health — Denver, Colorado, United States
• Encore Medical Research, Llc Hollywood — Hollywood, Florida, United States
• Lane Dermatology and Dermatologic Surgery — Columbus, Georgia, 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
• 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
• Clinical Research Center of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.