| Eligibility |
Inclusion Criteria:
- Male and female children aged = 2 years to < 12 years (age at the screening visit).
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
- AD duration of at least 3 months (participant/parent/guardian may verbally report
signs and symptoms of AD with onset at least 3 months prior to screening).
- An IGA score as follows:
- Treatment period: = 2 at the screening and baseline visits.
- LTS period: 0 to 4 at Week 8
- %BSA (excluding the scalp) with AD involvement as follows:
- Treatment period: = 35% at screening and baseline
- LTS period: 0% to 20% at Week 8
- For children aged 6 years to < 12 years, mean Itch NRS score = 4 during the screening
period.
- Participants/guardians who agree to discontinue all agents used by the participant to
treat AD from the screening visit through the final safety follow-up visit.
- At least 1 target lesion that measures approximately 5 cm2 or more at the screening
and baseline visits. The target lesion must be representative of the participant's
disease state but not located on the face, hands, feet, or genitalia.
- 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 male and female participants who are prepubescent.
- 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.
Exclusion Criteria:
- An unstable course of AD (spontaneously improving or rapidly deteriorating) as
determined by the investigator over the previous 4 weeks prior to the baseline visit.
- Concurrent conditions and history of other diseases as follows:
- Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome,
- Wiskott-Aldrich syndrome) or a history of malignant disease within 5 years before
the baseline visit.
- Chronic or acute infection requiring treatment with systemic antibiotics,
antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before
the baseline visit.
- Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex,
herpes zoster, chickenpox, clinically infected AD, impetigo) within 1 week before
the baseline 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.
- Other types of eczema.
- Chronic asthma requiring more than 800 µg/day of inhaled budesonide or equivalent
high dose of other inhaled corticosteroids.
- A medical history of hepatitis B virus or hepatitis C virus infection.
- Any participant on maintenance dialysis.
- Any of the following clinical laboratory test results at screening:
- Cytopenias at screening, defined as follows:
- Hemoglobin < 10 g/dL
- ANC < 1000/µL
- Platelet count < 100,000/µL
- Liver function tests:
- AST or ALT = 2.5 × ULN
- Total bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if
bilirubin is fractionated and direct bilirubin is < 35%).
- Estimated GFR < 30 mL/min/1.73 m2 (using the Modification of Diet in Renal
Disease equation)
- Positive serology test results at screening for HIV antibody.
- Any other clinically significant laboratory result that, in the opinion of the
investigator, pose a significant risk to the participant
- 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 drug and attending required study visits; pose a
significant risk to the participant; or interfere with interpretation of study data.
- Use of any of the following treatments within the indicated washout period before the
baseline visit:
- 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
- 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues,
cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or
immunomodulating agents (eg, mycophenolate, choroquine or tacrolimus).
- 2 weeks - immunizations with live-attenuated vaccines; sedating antihistamines
unless on a long-term stable regimen (nonsedating antihistamines are permitted).
Note: Live-attenuated vaccines are not recommended during the treatment period of
the study. COVID-19 vaccines are allowed during the study.
- 1 week - use of topical treatments for AD (other than bland emollients, creams,
ointments, sprays, soap substitutes), topical antipruritics (eg, doxepin cream),
corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo),
topical 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.
- Previous treatment with systemic or topical JAK inhibitors (eg, ruxolitinib,
tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
- 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, which is thought by the
investigator to potentially impact the participant's AD.
- Known or suspected hypersensitivity to either ruxolitinib or any component of its
cream vehicle.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer)
before the baseline visit with another investigational medication or current
enrollment in another investigational drug protocol.
- Inadequate venous access in nonlesional areas for laboratory blood draws.
- In the opinion of the investigator, unable or unlikely to comply with the
administration schedule and study evaluations.
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