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Safety and Efficacy of Baricitinib in Patients with Atopic Dermatitis
Study I4V-MC-JAHN (JAHN) is a Phase 3, multicenter, double-blind study to evaluate the long-term safety and efficacy of baricitnib (1-mg once daily, 2-mg once daily and 4-mg once daily) in adult patients with AD for approximately 2 years.
- Have completed the final active treatment visit for an originating study (i.e., Visit 8, Week 16 of JAHL or JAHM) eligible to enroll patients directly into Study JAHN.
- Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that develop during a previous baricritinib study that, in the opinion of the investigator, pose an unacceptable risk to the patient.
The study duration will be approximately 2 years with 17 study visits.