Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Inclusion Criteria:

• Adolescents aged ≥12 to 17 years, inclusive, and men and women aged ≥18 years.
• Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajkacriteria.
• AD duration of at least 2 years.
• Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 atscreening and Baseline [Vehicle Controlled (VC) Period] and 0 to 4 at Week 8 [Long-Term Safety (LTS) Period].
• Participants with percentage of Body Surface Area (% BSA) (excluding scalp) of ADinvolvement of 3% to 20% at screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period).
• Participants who agree to discontinue all agents used to treat AD from screeningthrough the final follow-up visit.
• Participants who have at least 1 "target lesion" that measures approximately 10 cm^2or more at screening and Baseline. Lesion must be representative of the participant'sdisease state and not be located on the hands, feet, or genitalia.
• Willingness to avoid pregnancy or fathering of children.

Exclusion Criteria:

• Unstable course of AD (spontaneously improving or rapidly deteriorating) as determinedby the investigator in the 4 weeks prior to Baseline.
• Concurrent conditions and history of other diseases:
• Immunocompromised.
• Chronic or acute infection requiring treatment with systemic antibiotics,antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks beforeBaseline.
• Active acute bacterial, fungal, or viral skin infection within 1 week beforeBaseline.
• Any other concomitant skin disorder, pigmentation, or extensive scarring that, inthe opinion of the investigator, may interfere with the evaluation of AD lesionsor compromise participant safety.
• Presence of AD lesions only on the hands or feet without prior history ofinvolvement of other classical areas of involvement such as the face or thefolds.
• Other types of eczema.
• Any serious illness or medical, physical, or psychiatric condition(s) that, in theinvestigator's opinion, would interfere with full participation in the study,including administration of study drug and attending required study visits; pose asignificant risk to the participant; or interfere with interpretation of study data.
• Use of any of the following treatments within the indicated washout period beforeBaseline:
• 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg. dupilumab).
• 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs,cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive orimmunomodulating agents (eg. mycophenolate or tacrolimus).
• 2 weeks - immunizations and sedating antihistamines, unless on long-term stableregimen (nonsedating antihistamines are permitted).
• 1 week - use of other topical treatments for AD (other than bland emollients).Diluted sodium hypochlorite "bleach" baths are allowed as long as they do notexceed 2 baths per week and their frequency remains the same throughout thestudy.
• Participants who have previously received Janus kinase (JAK) inhibitors, systemic ortopical.
• Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sourcesof UV radiation within 2 weeks prior to Baseline and/or intention to have suchexposure during the study, which is thought by the investigator to potentially impactthe participant's AD.
• Positive serology test results at screening for Human Immunodeficiency Virus (HIV)antibody.
• Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin > 1.5 ×ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated anddirect bilirubin < 35%).
• Pregnant or lactating participants, or those considering pregnancy.
• History of alcoholism or drug addiction within 1 year before screening or currentalcohol or drug use that, in the opinion of the investigator, will interfere with theparticipant's ability to comply with the administration schedule and studyassessments.
• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer)before Baseline with another investigational medication or current enrollment inanother investigational drug protocol.