Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 3 (TRuE-AD3)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Atopic Dermatitis (ad)
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Age: Between 2 - 11 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Diagnosis of Atopic Dermatitis (AD)
- AD duration of at least 3 months
- Eczema patches on the skin (if hands/feet or genitalia only they do not qualify)
- For children aged 6 years to < 12 years, baseline itch Numerical Rating Scale (NRS) score = 4
- 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
- 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
You may not be eligible for this study if the following are true:
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- An unstable course of Atopic Dermatitis (spontaneously improving or rapidly deteriorating)
- Concurrent conditions and history of other diseases
- 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 study visit
- Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, impetigo) within 1 week before the study visit
- Any other skin disorder (eg, generalized erythroderma such as Netherton syndrome), pigmentation, or extensive scarring
- Presence of AD lesions only on the hands or feet without prior history of lesions present in other classic areas of involvement such as the face or the flexural fold
- Other types of eczema
- Chronic asthma requiring more than 880 µg/day of inhaled budesonide or equivalent high dose of other inhaled corticosteroids
- Any participant on maintenance dialysis
- A medical history of hepatitis B virus or hepatitis C virus infection
- Any serious illness or medical, physical, or psychiatric condition(s) that would interfere with full participation in the study
- Previous treatment with systemic or topical JAK inhibitors
- Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation
- Current treatment or treatment within 30 days with another investigational medication or current enrollment in another investigational drug study
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.